RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-10-04
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05020236

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
  2. * Measurable disease based on IMWG criteria as defined by at least 1 of the following:
  3. * Serum M-protein ≥0.5 g/dL.
  4. * Urinary M-protein excretion ≥200 mg/24 hours.
  5. * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
  6. * Prior anti-multiple myeloma therapy including treatment with lenalidomide.
  7. * ECOG performance status ≤2.
  8. * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
  9. * Not pregnant and willing to use contraception.
  1. * Smoldering multiple myeloma.
  2. * Plasma cell leukemia.
  3. * Amyloidosis.
  4. * POEMS Syndrome.
  5. * Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
  6. * Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
  7. * 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.
  8. * Previous treatment with a BCMA-directed therapy.
  9. * Live attenuated vaccine within 4 weeks of the first dose of study intervention.
  10. * 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Clovis Community Medical Center
Clovis, California, 93611
United States
Community Cancer Institute
Clovis, California, 93611
United States
University of California San Francisco
Fresno, California, 93701
United States
Community Regional Medical Center
Fresno, California, 93721
United States
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, 80524
United States
UCHealth Harmony
Fort Collins, Colorado, 80528
United States
UCHealth Greeley Hospital
Greeley, Colorado, 80634
United States
UCHealth - Medical Center of the Rockies
Loveland, Colorado, 80538
United States
Sylvester Comprehensive Cancer Center - Aventura
Aventura, Florida, 33180
United States
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables, Florida, 33146
United States
Sylvester Comprehensive Cancer Center - Coral Springs
Coral Springs, Florida, 33065
United States
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, 33442
United States
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood, Florida, 33021
United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
University of Miami Hospital And Clinics
Miami, Florida, 33136
United States
Sylvester Comprehensive Cancer Center - Kendall
Miami, Florida, 33176
United States
Sylvester Comprehensive Cancer Center - Plantation
Plantation, Florida, 33324
United States
East Jefferson General Hospital Bone Marrow Transplant Clinic
Metairie, Louisiana, 70006
United States
East Jefferson General Hospital
Metairie, Louisiana, 70006
United States
MSK Basking Ridge
Basking Ridge, New Jersey, 07920
United States
MSK Monmouth
Middletown, New Jersey, 07748
United States
MSK Bergen
Montvale, New Jersey, 07645
United States
MSK Commack
Commack, New York, 11725
United States
MSK Westchester
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021
United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
United States
MSK Nassau
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-04
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2021-10-04
Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

  • Elranatamab
  • PF-06863135
  • B-Cell Maturation Antigen
  • BCMA
  • Bispecific antibody
  • BCMA-CD3 bispecific antibody
  • Daratumumab
  • Pomalidomide
  • Multiple myeloma
  • Relapsed multiple myeloma
  • Refractory multiple myeloma
  • MagnetisMM-5

Additional Relevant MeSH Terms

  • Multiple Myeloma