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)
Sanofi
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.
Description
The duration of the study for a participant will include a period for screening of up to 28 days, a study treatment period of 12 months (except early discontinuation), the end-of-treatment (EOT) visit about 30 days after the last dose of study treatment, and a study follow-up period until death or the final study cut-off date. A cycle duration is 28 days. After study treatment discontinuation, participants will return to the study site 30 days after the last dose of study treatment for the EOT visit or before further anti-myeloma therapy initiation, whichever comes first.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 ther…
Interventions
- DrugIsatuximab SC-OBDS
Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS
- DrugMontelukast
Pharmaceutical form:As per local commercial product-Route of administration:Oral
- DrugDexamethasone
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
- DrugAcetaminophen
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
- DrugDiphenhydramine
Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)
- DrugMethylprednisolone
Pharmaceutical form:As per local commercial product-Route of administration:IV
Locations (34)
- Mayo Clinic in Arizona - Phoenix- Site Number : 8400058Phoenix, Arizona
- Los Angeles Hematology Oncology Medical Group- Site Number : 8400027Los Angeles, California
- Private Practice - Dr. James R. Berenson- Site Number : 8400044West Hollywood, California
- Smilow Cancer Center at Yale-New Haven- Site Number : 8400020New Haven, Connecticut
- Maryland Oncology Hematology- Site Number : 8400038Washington D.C., District of Columbia
- Life Clinical Trials - Coral Springs- Site Number : 8400055Coral Springs, Florida