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

Description

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.

Conditions

Multiple Myeloma

Study Overview

Study Details

Study overview

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.

A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH CARFILZOMIB PLUS DEXAMETHASONE AND ELRANATAMAB IN COMBINATION WITH PF-07901801 IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA

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

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Beverly Hills

Beverly Hills Cancer Center, Beverly Hills, California, United States, 90211

Aventura

Sylvester Comprehensive Cancer Center - Aventura, Aventura, Florida, United States, 33180

Coral Gables

Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center, Coral Gables, Florida, United States, 33146

Coral Springs

Sylvester Comprehensive Cancer Center - Coral Springs, Coral Springs, Florida, United States, 33065

Deerfield Beach

University of Miami Hospital and Clinics - Deerfield Beach, Deerfield Beach, Florida, United States, 33442

Hollywood

Sylvester Comprehensive Cancer Center - Hollywood, Hollywood, Florida, United States, 33021

Miami

Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Miami

University of Miami Hospital And Clinics, Miami, Florida, United States, 33136

Miami

Sylvester Comprehensive Cancer Center - Kendall, Miami, Florida, United States, 33176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2027-11-05