A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma

Purpose

The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose.

Condition

  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Prior diagnosis of multiple myeloma as defined by IMWG criteria. - Measurable disease based on IMWG criteria as defined by at least 1 of the following: - Serum M-protein ≥0.5 g/dL. - Urinary M-protein excretion ≥200 mg/24 hours. - Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65). - Part 1: Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy). - Part 2: Received at least 3 prior lines of therapy for multiple myeloma who are refractory to at least one IMiD, one PI and one anti-CD38 antibody. - ECOG performance status 0-1. - Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1. - Not pregnant or breastfeeding and willing to use contraception.

Exclusion Criteria

  • Plasma cell leukemia, Smouldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome, Primary refractory MM - Impaired cardiovascular function or clinically significant cardiovascular diseases. - Participants with any active, uncontrolled bacterial, fungal, or viral infection. - Stem cell transplant within 12 weeks prior to enrollment, or active graft versus host disease. - Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. - Part 1: Previous treatment with a BCMA-directed therapy. - Part 2: Previous treatment with any anti-BCMA directed therapy, with the exception of CAR-T. Previous treatment with a CD47-SIRP alpha-directed therapy. - Part 1: Prior treatment with carfilzomib - Live attenuated vaccine within 4 weeks of the first dose of study intervention. - Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study. - Any of the following within 3 months of enrollment: erosive esophagitis, treatment resistant peptic ulcer, infectious or inflammatory bowel disease, pulmonary embolism or uncontrolled thromboembolic event. - Intolerance to or participants who have had a severe (Grade ≥3) allergic or anaphylactic reaction to antibodies or therapeutic proteins

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 Dose Escalation 		Non randomized Elranatamab plus Carfilzomib and Dexamethasone
  • Drug: Elranatamab
    BCMA-CD3 bispecific antibody
    Other names:
    • PF-06863135
  • Drug: Carfilzomib
    proteasome inhibitor
    Other names:
    • Kyprolis
Experimental
Part 2A Dose Escalation 		Non randomized Elranatamab plus Maplirpacept
  • Drug: Elranatamab
    BCMA-CD3 bispecific antibody
    Other names:
    • PF-06863135
  • Drug: Maplirpacept
    CD47-SIRP alpha-directed
    Other names:
    • PF-07901801, TTI-622
Experimental
Part 2B Dose Randomization 		Randomized dose level Elranatamab plus Maplirpacept
  • Drug: Elranatamab
    BCMA-CD3 bispecific antibody
    Other names:
    • PF-06863135
  • Drug: Maplirpacept
    CD47-SIRP alpha-directed
    Other names:
    • PF-07901801, TTI-622

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205

Beverly Hills Cancer Center
Beverly Hills 5328041, California 5332921 90211

Clinical Research Advisors (Encino Satellite Location)
Encino 5346649, California 5332921 91316

Clinical Research Advisors (Korea Town Satellite Location)
Los Angeles 5368361, California 5332921 90020

Clinical Research Advisors (West Hollywood Satellite Location)
Los Angeles 5368361, California 5332921 90048

Sylvester Comprehensive Cancer Center - Aventura
Aventura 4146429, Florida 4155751 33180

Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables 4151871, Florida 4155751 33146

Sylvester Comprehensive Cancer Center - Coral Springs
Coral Springs 4151909, Florida 4155751 33065

University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach 4153071, Florida 4155751 33442

Sylvester Comprehensive Cancer Center - Hollywood
Hollywood 4158928, Florida 4155751 33021

Griffin Cancer Research Building (GCRB)
Miami 4164138, Florida 4155751 33136

Sylvester Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33136

University of Miami Hospital and Clinics
Miami 4164138, Florida 4155751 33136

Sylvester Comprehensive Cancer Center - Kendall
Miami 4164138, Florida 4155751 33176

Sylvester Comprehensive Cancer Center - Plantation
Plantation 4168782, Florida 4155751 33324

Emory University Hospital Midtown
Atlanta 4180439, Georgia 4197000 30308

Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322

Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322

University of Iowa Hospitals and Clinics
Iowa City 4862034, Iowa 4862182 52242

Oncology Investigational Drug Service,Department of Pharmacy Services
Baltimore 4347778, Maryland 4361885 21231

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore 4347778, Maryland 4361885 21231

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

MSK Monmouth
Middletown 5101170, New Jersey 5101760 07748

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York 5128581, New York 5128638 10021

Memorial Sloan Kettering Cancer Center - Main Campus
New York 5128581, New York 5128638 10065

Henry-Joyce Cancer Clinic
Nashville 4644585, Tennessee 4662168 37232

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232

More Details

NCT ID
NCT05675449
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com