A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.

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

• Participants must have a documented diagnosis of MM.

• Participants with measurable disease defined as at least one of the following:

‣ Serum M-protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or

⁃ Urine M-protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or

⁃ Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65).

• Participants with relapsed and/or refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy.

• Contraceptive use by \[men and women\] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

‣ Male participants agree to practice true abstinence or agree to use contraception while receiving study treatment, during dose interruptions and at least 5 months following study treatment discontinuation, even if has undergone a successful vasectomy.

⁃ A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP XE FCBP \f Abbreviation \t female of childbearing potential ) or agrees to practice complete abstinence or use contraception.

• Capable of giving signed informed consent.

Locations
United States
California
Berenson Cancer Center- Site Number : 8400044
RECRUITING
West Hollywood
Connecticut
Smilow Cancer Center at Yale-New Haven- Site Number : 8400020
RECRUITING
New Haven
Florida
D&H Cancer Research Center- Site Number : 8400049
RECRUITING
Margate
Millennium Oncology- Site Number : 8400011
RECRUITING
Pembroke Pines
BRCR Global- Site Number : 8400008
RECRUITING
Plantation
Louisiana
Pontchartrain Cancer Center- Site Number : 8400046
RECRUITING
Covington
Michigan
Michigan Hematology and Oncology Consultants- Site Number : 8400036
RECRUITING
Dearborn
Michigan Hematology and Oncology Consultants- Site Number : 8400039
RECRUITING
Royal Oak
New Jersey
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021
RECRUITING
Hackensack
New Mexico
San Juan Oncology Associates- Site Number : 8400016
RECRUITING
Farmington
New York
Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003
RECRUITING
New York
Ohio
Gabrail Cancer Center- Site Number : 8400010
RECRUITING
Canton
South Carolina
Prisma Health - Eastside Office- Site Number : 8400019
RECRUITING
Greenville
Tennessee
Tennessee Cancer Specialist- Site Number : 8400035
RECRUITING
Knoxville
University of Tennessee Medical Center- Site Number : 8400006
RECRUITING
Knoxville
Wisconsin
SSM Health - Dean Medical Group South Madison Campus- Site Number : 8400009
RECRUITING
Madison
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2027-07-15
Participants
Target number of participants: 64
Treatments
Experimental: Isatuximab in combination with weekly carfilzomib and dexamethasone
Participants will receive isatuximab via SC-OBDS administration in combination with weekly carfilzomib and dexamethasone. Isatuximab will be administered on days 1, 8, 15 and 22 for Cycle 1 and then on days 1, 15 for subsequent cycles. Carfilzomib will be administered intravenously (IV) at a starting dose on Day 1 of Cycle 1 and then escalated dose on Days 8 and 15 of Cycle 1, followed by Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be given on Days 1, 8, 15, and 22 of Cycle 1 and then on Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be administered IV on Cycle 1 Day 1, and IV or PO in the subsequent administrations. 1 cycle = 28 days.
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov