RECRUITING

A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

Description

The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab. Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab. All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

Study Overview

Study Details

Study overview

The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab. Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab. All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR

A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Clovis

Clovis Community Medical Center, Clovis, California, United States, 93611

Clovis

Community Cancer Institute, Clovis, California, United States, 93611

Fresno

University of California San Francisco, Fresno, California, United States, 93701

Fresno

Community Regional Medical Center, Fresno, California, United States, 93721

Fort Collins

UCHealth Poudre Valley Hospital, Fort Collins, Colorado, United States, 80524

Fort Collins

UCHealth Harmony, Fort Collins, Colorado, United States, 80528

Greeley

UCHealth Greeley Hospital, Greeley, Colorado, United States, 80634

Loveland

UCHealth - Medical Center of the Rockies, Loveland, Colorado, United States, 80538

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

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 (Rajkumar et al, 2014).
  • * 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).
  • * Prior anti-multiple myeloma therapy including treatment with lenalidomide.
  • * ECOG performance status ≤2.
  • * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
  • * Not pregnant and willing to use contraception.
  • * Smoldering multiple myeloma.
  • * Plasma cell leukemia.
  • * Amyloidosis.
  • * POEMS Syndrome.
  • * Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
  • * Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
  • * Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • * Previous treatment with a BCMA-directed therapy.
  • * 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.

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

2027-05-31