RECRUITING

A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

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 main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide. There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma. Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement. All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle. Participants will receive study medicine until: * their disease progresses or, * they experience unacceptable side effects or, * they choose to no longer take part in the study. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.

Official Title

A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA

Quick Facts

Study Start:2024-02-20
Study Completion:2028-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06215118

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
  2. * Measurable disease based on IMWG criteria as defined by at least 1 of the following:
  3. * Serum M-protein ≥0.5 g/dL by SPEP
  4. * Urinary M-protein excretion ≥200 mg/24 hour by UPEP
  5. * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (\<0.26 or \>1.65)
  6. * Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
  7. * Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
  8. * ECOG performance status 0-1
  9. * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
  1. * Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome
  2. * Impaired cardiovascular function or clinically significant cardiovascular diseases
  3. * Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
  4. * Participants with any active, uncontrolled bacterial, fungal, or viral infection
  5. * 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
  6. * Previous treatment with:
  7. * BCMA-directed or CD3 redirecting therapy
  8. * Iberdomide (CC-220) or Mezigdomide
  9. * Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study
  10. * Administration with an investigational product within 30 days preceding the first dose of study intervention
  11. * Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis

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)

Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Indiana CTSI Clinical Research Center (ICRC)
Indianapolis, Indiana, 46202
United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC)
Indianapolis, Indiana, 46202
United States
University of Maryland
Baltimore, Maryland, 21201
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United States
Methodist Hospital
Omaha, Nebraska, 68114
United States
Oncology Hematology West P.C. dba Nebraska Cancer - Methodist
Omaha, Nebraska, 68114
United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
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 - Investigational Drug Service Pharmacy
Long Island City, New York, 11101
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 Date2024-02-20
Study Completion Date2028-05-31

Study Record Updates

Study Start Date2024-02-20
Study Completion Date2028-05-31

Terms related to this study

Keywords Provided by Researchers

  • elranatamab
  • PF-06863135
  • iberdomide
  • relapsed
  • refractory
  • RRMM
  • BCMA
  • MagnetisMM
  • Bispecific antibody
  • CC-220

Additional Relevant MeSH Terms

  • Multiple Myeloma