A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The main purpose of this study is to measure the efficacy (Myeloma response) of subcutaneous (SC) isatuximab treatment in combination with carfilzomib and dexamethasone in adult participants with RRMM having received 1 to 3 prior lines of therapy, and to characterize the PK of isatuximab in combination with carfilzomib and dexamethasone after manual and On Body Delivery System (OBDS) administration. After confirmation of the feasibility of SC isatuximab by manual administration, patient will be randomized to 1 of the 2 delivery methods of SC isatuximab.

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

∙ Participants must have a documented diagnosis of multiple myeloma (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).

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

• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP) or agrees to practice complete abstinence or use approved contraception methods.

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

• Capable of giving signed informed consent.

Locations
Other Locations
Australia
Investigational Site Number : 0360001
ACTIVE_NOT_RECRUITING
Fitzroy
Investigational Site Number : 0360002
ACTIVE_NOT_RECRUITING
Wollongong
Brazil
Hospital Mae de Deus Site Number : 0760002
RECRUITING
Porto Alegre
Clinica Sao Germano- Site Number : 0760003
RECRUITING
São Paulo
Hospital das Clinicas de Sao Paulo- Site Number : 0760001
RECRUITING
São Paulo
China
Investigational Site Number : 1560006
RECRUITING
Changsha
Investigational Site Number : 1560002
RECRUITING
Guangzhou
Investigational Site Number : 1560005
RECRUITING
Nanchang
Investigational Site Number : 1560004
RECRUITING
Shenyang
Investigational Site Number : 1560001
RECRUITING
Tianjin
Investigational Site Number : 1560007
RECRUITING
Tianjin
Investigational Site Number : 1560003
RECRUITING
Wuhan
Greece
Investigational Site Number : 3000001
RECRUITING
Athens
Investigational Site Number : 3000002
RECRUITING
Athens
Japan
Investigational Site Number : 3920001
ACTIVE_NOT_RECRUITING
Kashiwa-shi
Investigational Site Number : 3920002
ACTIVE_NOT_RECRUITING
Okayama
Portugal
Investigational Site Number : 6200001
ACTIVE_NOT_RECRUITING
Braga
Investigational Site Number : 6200004
ACTIVE_NOT_RECRUITING
Lisbon
Investigational Site Number : 6200005
ACTIVE_NOT_RECRUITING
Lisbon
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2023-04-05
Estimated Completion Date: 2028-05-12
Participants
Target number of participants: 118
Treatments
Experimental: Cohort 1: manual administration
Isatuximab will be administered manually for 8 minutes on Day 1 of Cycle 1 followed by 6 minutes from Day 8 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication.
Experimental: Part 1 Cohort 2: manual administration
Isatuximab will be administered manually for 6 minutes on Day 1 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication.
Experimental: Part 2 Cohort 3 Randomized Cohort: OBDS to manual
Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
Experimental: Part 2 Cohort 3 Randomized Cohort: Manual to OBDS
Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
Experimental: Part 3 Cohort 4 Randomized Cohort: OBDS to manual
Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
Experimental: Part 3 Cohort 4: Randomized Cohort: manual to OBDS
Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
Experimental: Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants
Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
Experimental: Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants
Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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