A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH CARFILZOMIB PLUS DEXAMETHASONE AND ELRANATAMAB IN COMBINATION WITH PF-07901801 IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose.

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.

⁃ 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).

• Part 1: Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy).

• Part 2: Received at least 3 prior lines of therapy for multiple myeloma who are refractory to at least one IMiD, one PI and one anti-CD38 antibody.

• ECOG performance status 0-1.

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

• Not pregnant or breastfeeding and willing to use contraception.

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
California
Beverly Hills Cancer Center
RECRUITING
Beverly Hills
Clinical Research Advisors (Encino Satellite Location)
RECRUITING
Encino
Clinical Research Advisors (Korea Town Satellite Location)
RECRUITING
Los Angeles
Clinical Research Advisors (West Hollywood Satellite Location)
RECRUITING
Los Angeles
Florida
Sylvester Comprehensive Cancer Center - Aventura
RECRUITING
Aventura
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
RECRUITING
Coral Gables
Sylvester Comprehensive Cancer Center - Coral Springs
RECRUITING
Coral Springs
University of Miami Hospital and Clinics - Deerfield Beach
RECRUITING
Deerfield Beach
Sylvester Comprehensive Cancer Center - Hollywood
RECRUITING
Hollywood
Griffin Cancer Research Building (GCRB)
RECRUITING
Miami
Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Sylvester Comprehensive Cancer Center - Kendall
RECRUITING
Miami
University of Miami Hospital and Clinics
RECRUITING
Miami
Sylvester Comprehensive Cancer Center - Plantation
RECRUITING
Plantation
Georgia
Emory University Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Winship Cancer Institute
RECRUITING
Atlanta
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Oncology Investigational Drug Service,Department of Pharmacy Services
RECRUITING
Baltimore
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
RECRUITING
Baltimore
New Jersey
MSK Monmouth
RECRUITING
Middletown
New York
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
Tennessee
Henry-Joyce Cancer Clinic
RECRUITING
Nashville
Vanderbilt University Medical Center
RECRUITING
Nashville
Other Locations
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Division of Hematology Hadassah Medical Center - Ein Kerem
RECRUITING
Jerusalem
Hematology Division Davidoff Center, Rabin Medical Center, Beilinson Hospital
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Tel-Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-12-14
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 90
Treatments
Experimental: Part 1 Dose Escalation
Non randomized Elranatamab plus Carfilzomib and Dexamethasone
Experimental: Part 2A Dose Escalation
Non randomized Elranatamab plus Maplirpacept
Experimental: Part 2B Dose Randomization
Randomized dose level Elranatamab plus Maplirpacept
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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