Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
Purpose
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.
Condition
- Plasma Cell Myeloma
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration - Participants must have measurable disease within 28 days prior to registration as defined by any of the following: - Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >= 0.5 gram/deciliter [g/dL] or urine M-protein level >= 200 milligram[mg]/24 hours[hrs]); OR - IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >= 0.2 g/dL or urine M-protein level >= 200 mg/24 hrs); OR - Light chain multiple myeloma (serum immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio) - All disease must be assessed and documented on the baseline/pre-registration tumor assessment form - Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration - For Participants Meeting "Frail" Status: - Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible - For Participants Meeting "Frail" Status: - Hemoglobin >= 7 g/dL (must be performed within 28 days prior to registration) - Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) - For Participants Meeting "Frail" Status: - Platelets >= 50 x 10^9/L (must be performed within 28 days prior to registration) - Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) - For Participants Meeting "Frail" Status: - Absolute neutrophil count (ANC) >= 0.75 x10^9/L (must be performed within 28 days prior to registration) - Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) - For Participants Meeting "Intermediate Fit" Status, one or more of the following criteria must be present: - Kidney dysfunction showing calculated creatinine clearance (CrCl) <30 ml/min. - Actual lab serum creatinine value with a minimum of 0.7 mg/dL. - Participants must have bone marrow function assessed and meet the below criteria ranges: - Hemoglobin between 7-8 g/dL, OR - Platelets between 50-75 x10^9/L, OR - ANC between 0.75-1 x10^9/L - Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM) - Revised International Staging System (R-ISS) stage III disease - Note: All labs must be performed within 28 days prior to registration - Participants must have a complete medical history and physical exam within 28 days prior to registration - Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography/computed tomography (PET/CT); a low-dose whole body CT scan or whole-body magnetic resonance imaging (MRI) or skeletal survey should be done only if a PET/CT scan cannot be done or is non-feasible. This must be documented in the comments section of the Onstudy form. - Total bilirubin =< 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN (within 28 days prior to registration) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 × institutional ULN (within 28 days prior to registration) - Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4 - Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C > 7 - Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to registration - All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration - Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load within 28 days prior to registration - Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2 (Note: Participants with ECOG/Zubrod performance score [PS] 3, especially where the deterioration of PS is considered secondary to the MM diagnosis, will be allowed) - Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system - Participants who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study - Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Exclusion Criteria
- Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following: - An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or - Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or - Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol. - Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration - Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =< 140 and DBP =< 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator. - Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen. - Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Arm I (VRd-Lite) |
INDUCTION CYCLES 1-9: Patients receive bortezomib SC on days 1, 8, 15, and 22 of each cycle, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
Experimental Arm II (DRd-R) |
INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
Experimental Arm III (DRd-DR): |
INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
Recruiting Locations
Anchorage 5879400, Alaska 5879092 98508
Anchorage 5879400, Alaska 5879092 99504
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Phoenix 5308655, Arizona 5551752 85004
Fort Smith 4111410, Arkansas 4099753 72903
Site Public Contact
800-378-9373
Little Rock 4119403, Arkansas 4099753 72205
Little Rock 4119403, Arkansas 4099753 72205
Site Public Contact
501-686-8274
Arroyo Grande 5324802, California 5332921 93420
Burbank 5331835, California 5332921 91505
Cameron Park 5333282, California 5332921 95682
Carmichael 5334336, California 5332921 95608
Carmichael 5334336, California 5332921 95608
Elk Grove 5346111, California 5332921 95758
Marysville 5370984, California 5332921 95901
Site Public Contact
530-749-4400
Merced 5372253, California 5332921 95340
Napa 5376095, California 5332921 94558
Site Public Contact
707-521-3830
Rocklin 5388319, California 5332921 95765
Sacramento 5389489, California 5332921 95816
Sacramento 5389489, California 5332921 95817
Site Public Contact
916-734-3089
San Luis Obispo 5392323, California 5332921 93401
Santa Maria 5393180, California 5332921 93444
Santa Rosa 5393287, California 5332921 95403
Site Public Contact
707-521-3830
Santa Rosa 5393287, California 5332921 95405
Site Public Contact
707-521-3830
Truckee 5403676, California 5332921 96161
Site Public Contact
530-582-6450
Woodland 5410430, California 5332921 95695
Aurora 5412347, Colorado 5417618 80045
Site Public Contact
888-336-8262
Colorado Springs 5417598, Colorado 5417618 80907
Colorado Springs 5417598, Colorado 5417618 80907
Colorado Springs 5417598, Colorado 5417618 80923
Durango 5420241, Colorado 5417618 81301
Durango 5420241, Colorado 5417618 81301
Lakewood 5427946, Colorado 5417618 80228
Longmont 5579276, Colorado 5417618 80501
Pueblo 5435464, Colorado 5417618 81004
Derby 4832745, Connecticut 4831725 06418
Fairfield 4834157, Connecticut 4831725 06824
Glastonbury 4835003, Connecticut 4831725 06033
Greenwich 4835395, Connecticut 4831725 06830
Guilford 4835512, Connecticut 4831725 06437
Hartford 4835797, Connecticut 4831725 06105
New Haven 4839366, Connecticut 4831725 06510
New Haven 4839366, Connecticut 4831725 06520
North Haven 4839704, Connecticut 4831725 06473
Stamford 4843564, Connecticut 4831725 06902
Torrington 4844309, Connecticut 4831725 06790
Trumbull 4844459, Connecticut 4831725 06611
Waterbury 4845193, Connecticut 4831725 06708
Waterford 8480031, Connecticut 4831725 06385
Fort Lauderdale 4155966, Florida 4155751 33308
Jacksonville 4160021, Florida 4155751 32224-9980
Site Public Contact
855-776-0015
Jupiter 4160610, Florida 4155751 33458
Site Public Contact
561-745-5768
Boise 5586437, Idaho 5596512 83712
Fruitland 5593708, Idaho 5596512 83619
Meridian 5600685, Idaho 5596512 83642
Nampa 5601933, Idaho 5596512 83686
Twin Falls 5610810, Idaho 5596512 83301
Alton 4232679, Illinois 4896861 62002
Site Public Contact
618-463-5623
Aurora 4883817, Illinois 4896861 60504
Bloomington 4885164, Illinois 4896861 61701
Bloomington 4885164, Illinois 4896861 61704
Burr Ridge 4886090, Illinois 4896861 60527
Site Public Contact
708-216-9000
Canton 4831990, Illinois 4896861 61520
Carbondale 4235193, Illinois 4896861 62902
Carterville 4235311, Illinois 4896861 62918
Carthage 4886716, Illinois 4896861 62321
Centralia 4235587, Illinois 4896861 62801
Centralia 4235587, Illinois 4896861 62801
Danville 4889426, Illinois 4896861 61832
Decatur 4236895, Illinois 4896861 62526
Decatur 4236895, Illinois 4896861 62526
Dixon 4889959, Illinois 4896861 61021
Site Public Contact
815-285-7800
Effingham 4237727, Illinois 4896861 62401
Effingham 4237727, Illinois 4896861 62401
Eureka 4891310, Illinois 4896861 61530
Galesburg 4893392, Illinois 4896861 61401
Galesburg 4893392, Illinois 4896861 61401
Site Public Contact
309-344-2831
Hines 4896005, Illinois 4896861 60141
Site Public Contact
708-202-8387
Homer Glen 4896336, Illinois 4896861 60491
Site Public Contact
708-216-9000
Kewanee 4898433, Illinois 4896861 61443
Macomb 4900817, Illinois 4896861 61455
Mattoon 4244099, Illinois 4896861 61938
Maywood 4901514, Illinois 4896861 60153
Site Public Contact
708-226-4357
Melrose Park 4901868, Illinois 4896861 60160
Site Public Contact
708-450-4554
Mount Vernon 4245152, Illinois 4896861 62864
Site Public Contact
618-242-4600
O'Fallon 4245926, Illinois 4896861 62269
O'Fallon 4245926, Illinois 4896861 62269
Ottawa 4905006, Illinois 4896861 61350
Pekin 4905599, Illinois 4896861 61554
Peoria 4905687, Illinois 4896861 61615
Peoria 4905687, Illinois 4896861 61636
Peru 4905770, Illinois 4896861 61354
Peru 4905770, Illinois 4896861 61354
Site Public Contact
815-664-4141
Princeton 4906818, Illinois 4896861 61356
Springfield 4250542, Illinois 4896861 62702
Site Public Contact
217-545-7929
Springfield 4250542, Illinois 4896861 62702
Site Public Contact
800-444-7541
Springfield 4250542, Illinois 4896861 62781
Urbana 4914570, Illinois 4896861 61801
Urbana 4914570, Illinois 4896861 61801
Washington 4915545, Illinois 4896861 61571
Yorkville 4917298, Illinois 4896861 60560
Carmel 4255466, Indiana 4921868 46032
Crown Point 4919451, Indiana 4921868 46307
Site Public Contact
219-310-2550
Dyer 4919820, Indiana 4921868 46311
Site Public Contact
219-924-8178
Hobart 4921476, Indiana 4921868 46342
Site Public Contact
219-947-1795
Hobart 4921476, Indiana 4921868 46342
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46312
Munster 4924014, Indiana 4921868 46321
Site Public Contact
219-836-3349
Munster 4924014, Indiana 4921868 46321
Richmond 4263681, Indiana 4921868 47374
Valparaiso 4927537, Indiana 4921868 46383
Ankeny 4846960, Iowa 4862182 50023
Site Public Contact
515-282-2921
Bettendorf 4848489, Iowa 4862182 52722
Cedar Rapids 4850751, Iowa 4862182 52402
Site Public Contact
319-297-2900
Clive 4852065, Iowa 4862182 50325
Site Public Contact
515-241-3305
Clive 4852065, Iowa 4862182 50325
Creston 4853078, Iowa 4862182 50801
Des Moines 4853828, Iowa 4862182 50314
Des Moines 4853828, Iowa 4862182 50314
Site Public Contact
515-241-3305
Iowa City 4862034, Iowa 4862182 52242
Site Public Contact
800-237-1225
West Des Moines 4881346, Iowa 4862182 50266
Garden City 5445439, Kansas 4273857 67846
Great Bend 4272340, Kansas 4273857 67530
Bardstown 4283133, Kentucky 6254925 40004
Corbin 4288656, Kentucky 6254925 40701
Lexington 4297983, Kentucky 6254925 40504
Lexington 4297983, Kentucky 6254925 40504
Lexington 4297983, Kentucky 6254925 40509
London 4298960, Kentucky 6254925 40741
Mount Sterling 4301683, Kentucky 6254925 40353
Baltimore 4347778, Maryland 4361885 21204
Site Public Contact
443-849-3706
Ann Arbor 4984247, Michigan 5001836 48106
Battle Creek 4985153, Michigan 5001836 49017
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48114
Canton 4987990, Michigan 5001836 48188
Canton 4987990, Michigan 5001836 48188
Caro 4988059, Michigan 5001836 48723
Chelsea 4988628, Michigan 5001836 48118
Chelsea 4988628, Michigan 5001836 48118
Clarkston 4988997, Michigan 5001836 48346
Clarkston 4988997, Michigan 5001836 48346
Detroit 4990729, Michigan 5001836 48236
East China Township, Michigan 5001836 48054
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49009
Kalamazoo 4997787, Michigan 5001836 49048
Lansing 4998830, Michigan 5001836 48912
Livonia 4999837, Michigan 5001836 48154
Macomb 5000473, Michigan 5001836 48044
Marlette 5000938, Michigan 5001836 48453
Muskegon 5003132, Michigan 5001836 49444
Niles 5003514, Michigan 5001836 49120
Site Public Contact
616-391-1230
Norton Shores 5004005, Michigan 5001836 49444
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Reed City 5006946, Michigan 5001836 49677
Saginaw 5007989, Michigan 5001836 48601
Saginaw 5007989, Michigan 5001836 48604
Saint Joseph 5008327, Michigan 5001836 49085
Saint Joseph 5008327, Michigan 5001836 49085
Sterling Heights 5011148, Michigan 5001836 48312
Tawas City 5011900, Michigan 5001836 48764
Traverse City 5012495, Michigan 5001836 49684
Warren 5014051, Michigan 5001836 48088
Warren 5014051, Michigan 5001836 48093
Warren 5014051, Michigan 5001836 48093
Warren 5014051, Michigan 5001836 48093
Warren 5014051, Michigan 5001836 48093
West Branch 5014413, Michigan 5001836 48661
Wyoming 5015618, Michigan 5001836 49519
Ypsilanti 5015688, Michigan 5001836 48106
Ypsilanti 5015688, Michigan 5001836 48197
Aitkin 5015978, Minnesota 5037779 56431
Baxter 5017396, Minnesota 5037779 56425
Site Public Contact
218-828-2880
Bemidji 5017822, Minnesota 5037779 56601
Brainerd 5019116, Minnesota 5037779 56401
Burnsville 5019767, Minnesota 5037779 55337
Cambridge 5020068, Minnesota 5037779 55008
Coon Rapids 5022025, Minnesota 5037779 55433
Deer River 5024099, Minnesota 5037779 56636
Detroit Lakes 5024237, Minnesota 5037779 56501
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Edina 5025264, Minnesota 5037779 55435
Ely 5025627, Minnesota 5037779 55731
Site Public Contact
218-365-7900
Fosston 5027191, Minnesota 5037779 56542
Hibbing 5030005, Minnesota 5037779 55746
Site Public Contact
218-786-3308
International Falls 5031404, Minnesota 5037779 56649
Site Public Contact
218-283-9431
Maple Grove 5036493, Minnesota 5037779 55369
Maplewood 5036588, Minnesota 5037779 55109
Maplewood 5036588, Minnesota 5037779 55109
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55415
Minneapolis 5037649, Minnesota 5037779 55454
Monticello 5038045, Minnesota 5037779 55362
Moose Lake 5038132, Minnesota 5037779 55767
Site Public Contact
218-485-4481
New Ulm 5039173, Minnesota 5037779 56073
Park Rapids 5040822, Minnesota 5037779 56470
Princeton 5042360, Minnesota 5037779 55371
Robbinsdale 5043439, Minnesota 5037779 55422
Rochester 5043473, Minnesota 5037779 55905
Site Public Contact
855-776-0015
Saint Louis Park 5045021, Minnesota 5037779 55416
Saint Paul 5045360, Minnesota 5037779 55101
Saint Paul 5045360, Minnesota 5037779 55102
Sandstone 5045908, Minnesota 5037779 55072
Shakopee 5046997, Minnesota 5037779 55379
Stillwater 5048814, Minnesota 5037779 55082
Thief River Falls 5049970, Minnesota 5037779 56701
Site Public Contact
605-312-3320
Virginia 5051468, Minnesota 5037779 55792
Waconia 5051640, Minnesota 5037779 55387
Willmar 5052916, Minnesota 5037779 56201
Woodbury 5053358, Minnesota 5037779 55125
Worthington 5053460, Minnesota 5037779 56187
Site Public Contact
605-312-3320
Wyoming 5053526, Minnesota 5037779 55092
Ballwin 4375663, Missouri 4398678 63011
Site Public Contact
314-251-7058
Bolivar 4377835, Missouri 4398678 65613
Branson 4378219, Missouri 4398678 65616
Site Public Contact
417-269-4520
Cape Girardeau 4379966, Missouri 4398678 63703
Cape Girardeau 4379966, Missouri 4398678 63703
Site Public Contact
573-651-5550
Farmington 4386289, Missouri 4398678 63640
Site Public Contact
314-996-5569
Jefferson City 4392388, Missouri 4398678 65109
Joplin 4392768, Missouri 4398678 64804
Joplin 4392768, Missouri 4398678 64804
Kansas City 4393217, Missouri 4398678 64132
Osage Beach 4402040, Missouri 4398678 65065
Rolla 4406282, Missouri 4398678 65401
Rolla 4406282, Missouri 4398678 65401
Site Public Contact
573-458-6379
Saint Joseph 4407010, Missouri 4398678 64506
Sainte Genevieve 4407294, Missouri 4398678 63670
Site Public Contact
314-996-5569
Springfield 4409896, Missouri 4398678 65804
Site Public Contact
417-269-4520
Springfield 4409896, Missouri 4398678 65807
Site Public Contact
417-269-4520
St Louis 4407066, Missouri 4398678 63109
Site Public Contact
314-353-1870
St Louis 4407066, Missouri 4398678 63128
St Louis 4407066, Missouri 4398678 63131
Site Public Contact
314-996-5569
St Louis 4407066, Missouri 4398678 63141
Site Public Contact
314-251-7066
Sullivan 4410669, Missouri 4398678 63080
Site Public Contact
314-996-5569
Sunset Hills 4410836, Missouri 4398678 63127
Site Public Contact
314-996-5569
Washington 4413621, Missouri 4398678 63090
Site Public Contact
636-390-1600
Missoula 5666639, Montana 5667009 59802
Kearney 5071348, Nebraska 5073708 68847
Omaha 5074472, Nebraska 5073708 68122
Omaha 5074472, Nebraska 5073708 68124
Omaha 5074472, Nebraska 5073708 68130
Omaha 5074472, Nebraska 5073708 68131
Exeter 5085966, New Hampshire 5090174 03833
Site Public Contact
800-439-3837
Albuquerque 5454711, New Mexico 5481136 87102
Albuquerque 5454711, New Mexico 5481136 87102
Albuquerque 5454711, New Mexico 5481136 87110
Rio Rancho 5487811, New Mexico 5481136 87124
New York 5128581, New York 5128638 10032
Rochester 5134086, New York 5128638 14642
Site Public Contact
585-275-5830
Bismarck 5688025, North Dakota 5690763 58501
Fargo 5059163, North Dakota 5690763 58103
Fargo 5059163, North Dakota 5690763 58103
Site Public Contact
701-234-6161
Fargo 5059163, North Dakota 5690763 58103
Site Public Contact
605-312-3320
Fargo 5059163, North Dakota 5690763 58104
Site Public Contact
800-437-4010
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Jamestown 5059836, North Dakota 5690763 58401
Beavercreek 4506008, Ohio 5165418 45431
Boardman 5147784, Ohio 5165418 44512
Centerville 4508204, Ohio 5165418 45459
Cincinnati 4508722, Ohio 5165418 45220
Cincinnati 4508722, Ohio 5165418 45236
Cincinnati 4508722, Ohio 5165418 45242
Cincinnati 4508722, Ohio 5165418 45247
Cincinnati 4508722, Ohio 5165418 45255
Dayton 4509884, Ohio 5165418 45415
Findlay 5153924, Ohio 5165418 45840
Findlay 5153924, Ohio 5165418 45840
Findlay 5153924, Ohio 5165418 45840
Franklin 4512203, Ohio 5165418 45005
Greenville 5156493, Ohio 5165418 45331
Greenville 5156493, Ohio 5165418 45331
Kettering 4515843, Ohio 5165418 45409
Kettering 4515843, Ohio 5165418 45429
Troy 5174358, Ohio 5165418 45373
Warren 5175865, Ohio 5165418 44484
Youngstown 5177568, Ohio 5165418 44501
Oklahoma City 4544349, Oklahoma 4544379 73120
Site Public Contact
405-752-3402
Bend 5713587, Oregon 5744337 97701
Clackamas 5719308, Oregon 5744337 97015
Clackamas 5719308, Oregon 5744337 97015
Coos Bay 5720495, Oregon 5744337 97420
Medford 5740099, Oregon 5744337 97504
Newberg 5742726, Oregon 5744337 97132
Oregon City 5744253, Oregon 5744337 97045
Portland 5746545, Oregon 5744337 97213
Portland 5746545, Oregon 5744337 97225
Redmond 5747882, Oregon 5744337 97756
Site Public Contact
541-706-2909
Allentown 5178127, Pennsylvania 6254927 18103
Bethlehem 5180225, Pennsylvania 6254927 18017
Danville 5186327, Pennsylvania 6254927 17822
East Stroudsburg 5188075, Pennsylvania 6254927 18301
Hazleton 5193011, Pennsylvania 6254927 18201
Lewisburg 5197842, Pennsylvania 6254927 17837
Scranton 5211303, Pennsylvania 6254927 18510
Wilkes-Barre 5219488, Pennsylvania 6254927 18711
Westerly 5225631, Rhode Island 5224323 02891
Boiling Springs 4571805, South Carolina 4597040 29316
Site Public Contact
864-241-6251
Easley 4577263, South Carolina 4597040 29640
Greenville 4580543, South Carolina 4597040 29605
Site Public Contact
864-241-6251
Greenville 4580543, South Carolina 4597040 29605
Site Public Contact
864-241-6251
Greenville 4580543, South Carolina 4597040 29615
Site Public Contact
864-241-6251
Greer 4580599, South Carolina 4597040 29650
Site Public Contact
864-241-6251
Seneca 4595346, South Carolina 4597040 29672
Site Public Contact
864-241-6251
Aberdeen 5225857, South Dakota 5769223 57401
Sioux Falls 5231851, South Dakota 5769223 57104
Sioux Falls 5231851, South Dakota 5769223 57105
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Yankton 5233053, South Dakota 5769223 57078
Conroe 4682991, Texas 4736286 77384
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Site Public Contact
713-873-2000
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Site Public Contact
800-553-2278
Houston 4699066, Texas 4736286 77079
League City 4705692, Texas 4736286 77573
San Antonio 4726206, Texas 4736286 78229
Sugar Land 4734825, Texas 4736286 77478
Martinsville 4771808, Virginia 6254928 24115
Richmond 4781708, Virginia 6254928 23229
Richmond 4781708, Virginia 6254928 23235
Richmond 4781708, Virginia 6254928 23298
South Hill 4786619, Virginia 6254928 23970
Aberdeen 5785243, Washington 5815135 98520
Bellingham 5786899, Washington 5815135 98225
Site Public Contact
360-788-8223
Bremerton 5788054, Washington 5815135 98310
Centralia 5789683, Washington 5815135 98531
Edmonds 5793427, Washington 5815135 98026
Everett 5793933, Washington 5815135 98201
Issaquah 5798487, Washington 5815135 98029
Kennewick 5799610, Washington 5815135 99336
Lacey 5800112, Washington 5815135 98503
Longview 5801617, Washington 5815135 98632
Seattle 5809844, Washington 5815135 98107
Seattle 5809844, Washington 5815135 98122-5711
Seattle 5809844, Washington 5815135 98122
Sedro-Woolley 5809902, Washington 5815135 98284
Shelton 5810176, Washington 5815135 98584
Vancouver 5814616, Washington 5815135 98664
Walla Walla 5814916, Washington 5815135 99362
Yelm 5816656, Washington 5815135 98597
Charleston 4801859, West Virginia 4826850 25304
Site Public Contact
304-388-9944
Antigo 5244010, Wisconsin 5279468 54409
Appleton 5244080, Wisconsin 5279468 54911
Ashland 5244247, Wisconsin 5279468 54806
Ashland 5244247, Wisconsin 5279468 54806
Chippewa Falls 5248511, Wisconsin 5279468 54729
Eau Claire 5251436, Wisconsin 5279468 54701
Hayward 5255882, Wisconsin 5279468 54843
La Crosse 5258957, Wisconsin 5279468 54601
Ladysmith 5259048, Wisconsin 5279468 54848
Marshfield 5261969, Wisconsin 5279468 54449
Medford 5262475, Wisconsin 5279468 54451
Minocqua 5263156, Wisconsin 5279468 54548
Neillsville 5264241, Wisconsin 5279468 54456
New Richmond 5264475, Wisconsin 5279468 54017
Rhinelander 5268720, Wisconsin 5279468 54501
Rice Lake 5268798, Wisconsin 5279468 54868
Spooner 5274034, Wisconsin 5279468 54801
Stevens Point 5274644, Wisconsin 5279468 54481
Stevens Point 5274644, Wisconsin 5279468 54482
Superior 5275191, Wisconsin 5279468 54880
Site Public Contact
701-364-6272
Wausau 5278120, Wisconsin 5279468 54401
Site Public Contact
877-405-6866
Wausau 5278120, Wisconsin 5279468 54401
Weston 5278693, Wisconsin 5279468 54476
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
Site Public Contact
715-422-7718
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
More Details
- NCT ID
- NCT05561387
- Status
- Recruiting
- Sponsor
- SWOG Cancer Research Network
Detailed Description
PRIMARY OBJECTIVES: I. To compare progression-free survival (PFS) in frail or selected intermediate fit newly diagnosed multiple myeloma (NDMM) participants treated with bortezomib with lenalidomide and dexamethasone at reduced dosing (VRd-Lite) induction followed by lenalidomide maintenance (Arm 1) versus daratumumab and hyaluronidase-fihj with lenalidomide and dexamethasone (DRd) induction followed by lenalidomide maintenance (Arm 2). II. To compare overall survival (OS) in frail or selected intermediate fit NDMM participants treated with VRd-Lite induction followed by lenalidomide maintenance (Arm 1) versus DRd induction followed by lenalidomide and daratumumab and hyaluronidase-fihj maintenance (Arm 3). SECONDARY OBJECTIVES: I. To compare PFS in Arm 1 versus Arm 3 II. To compare OS in Arm 1 versus Arm 2. III. To compare PFS in Arm 2 versus 3. IV. To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3. V. To compare the safety of Arm 1 with the safety of Arm 2 and Arm 3. VI. To explore veinous thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms. VII. To describe median time to response (complete response [CR] or better per International Myeloma Working Group [IMWG] criteria, very good partial response [VGPR] or better per IMWG criteria, partial response [PR] or better per IMWG criteria) on the three study arms. PRIMARY QUALITY OF LIFE (QOL) OBJECTIVE: I. To compare patient-reported global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) at 9 months after randomization (end of induction therapy) using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30). SECONDARY QOL OBJECTIVE: II. To compare longitudinal changes in global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) from baseline to 9 months after randomization (end of induction therapy). PATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (PRO-CTCAE) OBJECTIVE: I. To compare selected patient-reported outcome symptoms using PRO-CTCAE items among the 3 study arms. ADDITIONAL OBJECTIVES: I. To compare the rate of minimal residual disease (MRD) by clonoSEQ after 9 cycles of induction in Arm 1 versus Arm 2 and Arm 3, respectively. II. To compare the rate of MRD conversion after 1 year of maintenance in participants who were MRD positive after induction in Arm 1 versus Arm 2 and Arm 3, respectively. III. To compare the rate of sustained MRD negativity at time points of post-induction, post-1 year maintenance in Arm 1 versus Arm 2 and Arm 3, respectively. BANKING OBJECTIVES: I. To bank specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I (VRd-Lite): INDUCTION CYCLES 1-9: Patients receive bortezomib subcutaneously (SC) on days 1, 8, 15, and 22 of each cycle, lenalidomide orally (PO) on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II (DRd-R): INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM III (DRd-DR): INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years.