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A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

ConditionPlasma Cell Myeloma Refractory
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanofi

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have a documented diagnosis of MM.

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).

Disqualifiers

Primary refractory MM defined as participants who have never achieved at least a minimal response (MR) with any treatment during the disease course.

Participants with prior anti-CD38 treatment if: a) administered < 6 months before first isatuximab administration or, b) intolerant to the anti-CD38 previously received.

Participants who are refractory to carfilzomib.

Known history of allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib), prior hypersensitivity to sucrose, histidine (as base and hydrochloride salt), polysorbate 80, or any of the components (active substance or excipient) of study treatment that are not amenable to premedication with steroids, or intolerance to arginine and Poloxamer 188 that would prohibit further treatment with these agents.

Trial design

Design model

Single group

Treatments tested in this trial

  • Isatuximab SC-OBDS

    Drug

    Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS

  • Montelukast

    Drug

    Pharmaceutical form:As per local commercial product-Route of administration:Oral

  • Dexamethasone

    Drug

    Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV

  • Acetaminophen

    Drug

    Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV

  • Diphenhydramine

    Drug

    Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)

  • Methylprednisolone

    Drug

    Pharmaceutical form:As per local commercial product-Route of administration:IV

  • Carfilzomib

    Drug

    Pharmaceutical form:As per local commercial product-Route of administration:IV

Treatment groups

64 Participants
are divided into 1 treatment group
Group A: Isatuximab in combination with weekly carfilzomib and dexamethasoneExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to IMWG criteria assessed by investigator.

Time frame
6 months after the Last Participant In (LPI) i.e., approximately 32 months

Secondary outcomes

1

Number of participants with infusion reactions (IRs)

Time frame
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
2

Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable)

Time frame
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
3

Number of participants with injection site reactions (ISRs)

Time frame
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months
4

CR or better

CR or better assessed according to International Myeloma Working Group (IMWG) criteria assessed by investigator. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow aspirates, and a normal FLC ratio of 0.26-1.65 is required for FLC disease only. Two consecutive assessments are needed. No known evidence of progressive disease or new bone/soft tissue lesions if radiographic studies were performed.

Time frame
12 months after the Last Participant In (LPI) i.e., approximately 38 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Source ClinicalTrials.gov
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