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

Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 by SPEP

• Urinary M-protein excretion ≥200 mg/24 hour by UPEP

• Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (\<0.26 or \>1.65)

• Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.

• ECOG performance status 0-1

• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

Locations
United States
Georgia
Emory University Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Winship Cancer Institute
RECRUITING
Atlanta
Indiana
Indiana CTSI Clinical Research Center (ICRC)
RECRUITING
Indianapolis
Indiana University Health University Hospital
RECRUITING
Indianapolis
Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC)
RECRUITING
Indianapolis
Massachusetts
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Dana-Farber Cancer Institute
NOT_YET_RECRUITING
Boston
Dana-Farber Cancer Institute - Chestnut Hill
NOT_YET_RECRUITING
Newton
University of Massachusetts Chan Medical School
NOT_YET_RECRUITING
Worcester
Maryland
University of Maryland
RECRUITING
Baltimore
Nebraska
Methodist Hospital
RECRUITING
Omaha
Oncology Hematology West P.C. dba Nebraska Cancer - Methodist
RECRUITING
Omaha
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
RECRUITING
Omaha
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
MSK Basking Ridge
RECRUITING
Basking Ridge
MSK Monmouth
RECRUITING
Middletown
MSK Bergen
RECRUITING
Montvale
New York
MSK Commack
RECRUITING
Commack
MSK Westchester
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
RECRUITING
Long Island City
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
RECRUITING
New York
Memorial Sloan Kettering Cancer Center - Main Campus
RECRUITING
New York
MSK Nassau
RECRUITING
Uniondale
Washington
Fred Hutchinson Cancer Center
NOT_YET_RECRUITING
Seattle
University of Washington
NOT_YET_RECRUITING
Seattle
Other Locations
Australia
Townsville University Hospital
RECRUITING
Douglas
Epworth Freemasons
RECRUITING
East Melbourne
Liverpool Hospital
RECRUITING
Liverpool
Epworth Hospital
RECRUITING
Richmond
Slade Pharmacy
RECRUITING
Richmond
Calvary Mater Newcastle
RECRUITING
Waratah
Canada
Dr. Everett Chalmers Regional Hospital
RECRUITING
Fredericton
CIUSSS de l'Est-de-l'Île-de-Montréal
NOT_YET_RECRUITING
Montreal
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
RECRUITING
Sherbrooke
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2028-03-09
Participants
Target number of participants: 87
Treatments
Experimental: Part 1 Dose Escalation
Non-randomized elranatamab plus iberdomide
Experimental: Part 2 Dose Randomization
Randomized elranatamab plus iberdomide
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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