RECRUITING

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

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 study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: * Are 18 years of age or older and have MM. * Have received treatments before for MM. * Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: * a shot under the skin at the study clinic * through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.

Official Title

A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY

Quick Facts

Study Start:2024-02-08
Study Completion:2028-03-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06152575

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 International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
  2. * Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
  3. * Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
  4. * Have clinical laboratory values within the specified range.
  5. * ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
  6. * Not pregnant or breastfeeding and willing to use contraception.
  1. * Smoldering multiple myeloma.
  2. * Plasma cell leukemia.
  3. * Amyloidosis.
  4. * Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
  5. * Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
  6. * Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
  7. * Any active, uncontrolled bacterial, fungal, or viral infection.
  8. * Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
  9. * Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
  10. * Unable to receive investigator's choice therapy.
  11. * Live attenuated vaccine within 4 weeks of the first dose of study intervention.
  12. * Administration with an investigational product (e.g. drug or vaccine) 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)

Infirmary Cancer Care
Mobile, Alabama, 36607
United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211
United States
Community Cancer Institute
Clovis, California, 93611
United States
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817
United States
University of California
Sacramento, California, 95817
United States
UCHealth Harmony
Fort Collins, Colorado, 80528
United States
Longs Peak Hospital
Longmont, Colorado, 80504
United States
BRCR Global
Plantation, Florida, 33322
United States
BRCR Global
Plantation, Florida, 33322
United States
BRCR Global - Tamarac
Tamarac, Florida, 33321
United States
BRCR Global
Tamarac, Florida, 33321
United States
Community Health Network, Inc.
Indianapolis, Indiana, 46227
United States
Community Health Network, Inc.
Indianapolis, Indiana, 46250
United States
Community Health Network, Inc.
Indianapolis, Indiana, 46256
United States
Ascentist Doctor Hospital
Leawood, Kansas, 66211
United States
Alliance for Multispecialty Research, LLC
Merriam, Kansas, 66204
United States
O'Brien Pharmacy
Mission, Kansas, 66205
United States
Bryan Medical Center
Lincoln, Nebraska, 68506-1299
United States
NHO Revive Research Institute, LLC
Lincoln, Nebraska, 68506
United States
WMCHealth Advanced Physician Services
Hawthorne, New York, 10532
United States
Cayuga Cancer Center at Cayuga Park
Ithaca, New York, 14850
United States
Cayuga Medical Center
Ithaca, New York, 14850
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
TriHealth Cancer Institute-Good Samaritan Hospital
Cincinnati, Ohio, 45220
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
St Francis Cancer Center
Greenville, South Carolina, 29607
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Houston Methodist Willowbrook Hospital
Houston, Texas, 77070
United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, 77479
United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508
United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
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 Date2024-02-08
Study Completion Date2028-03-24

Study Record Updates

Study Start Date2024-02-08
Study Completion Date2028-03-24

Terms related to this study

Keywords Provided by Researchers

  • Elranatamab
  • B-Cell Maturation Antigen
  • BCMA
  • Bispecific antibody
  • BCMA-CD3 bispecific antibody
  • Myeloma
  • Multiple myeloma
  • Relapsed multiple myeloma
  • Refractory multiple myeloma
  • MagnetisMM
  • MagnetisMM-32
  • Pomalidomide
  • Elotuzumab
  • Bortezomib
  • Carfilzomib
  • PF-06863135

Additional Relevant MeSH Terms

  • Multiple Myeloma