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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-05

Study Completion Date

2028-05-12

Brief Summary

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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.

Detailed Description

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The duration of the study for a participant will include a period for screening of up to 28 days. A cycle duration is 28 days. Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue treatment, or any other reason, as well as the study treatment is commercially available and reimbursed in the participant's country, or is available from another source, whichever is first. The overall study duration will be of approximately 45 months.

Conditions

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Relapsed/Refractory Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Isatuximab

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous

Carfilzomib

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Dexamethasone

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral

Dexamethasone IV

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Montelukast

Intervention Type DRUG

Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral

Acetaminophen

Intervention Type DRUG

Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)

Diphenhydramine

Intervention Type DRUG

Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV

Methylprednisolone

Intervention Type DRUG

Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV

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.

Group Type EXPERIMENTAL

Isatuximab

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous

Carfilzomib

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Dexamethasone

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral

Dexamethasone IV

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Montelukast

Intervention Type DRUG

Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral

Acetaminophen

Intervention Type DRUG

Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)

Diphenhydramine

Intervention Type DRUG

Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV

Methylprednisolone

Intervention Type DRUG

Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV

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.

Group Type EXPERIMENTAL

Isatuximab

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous

Carfilzomib

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Dexamethasone

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral

Dexamethasone IV

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Montelukast

Intervention Type DRUG

Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral

Acetaminophen

Intervention Type DRUG

Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)

Diphenhydramine

Intervention Type DRUG

Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV

Methylprednisolone

Intervention Type DRUG

Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV

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.

Group Type EXPERIMENTAL

Isatuximab

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous

Carfilzomib

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Dexamethasone

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral

Dexamethasone IV

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Montelukast

Intervention Type DRUG

Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral

Acetaminophen

Intervention Type DRUG

Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)

Diphenhydramine

Intervention Type DRUG

Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV

Methylprednisolone

Intervention Type DRUG

Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV

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.

Group Type EXPERIMENTAL

Isatuximab

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous

Carfilzomib

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Dexamethasone

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral

Dexamethasone IV

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Montelukast

Intervention Type DRUG

Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral

Acetaminophen

Intervention Type DRUG

Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)

Diphenhydramine

Intervention Type DRUG

Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV

Methylprednisolone

Intervention Type DRUG

Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV

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.

Group Type EXPERIMENTAL

Isatuximab

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous

Carfilzomib

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Dexamethasone

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral

Dexamethasone IV

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Montelukast

Intervention Type DRUG

Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral

Acetaminophen

Intervention Type DRUG

Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)

Diphenhydramine

Intervention Type DRUG

Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV

Methylprednisolone

Intervention Type DRUG

Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV

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.

Group Type EXPERIMENTAL

Isatuximab

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous

Carfilzomib

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Dexamethasone

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral

Dexamethasone IV

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Montelukast

Intervention Type DRUG

Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral

Acetaminophen

Intervention Type DRUG

Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)

Diphenhydramine

Intervention Type DRUG

Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV

Methylprednisolone

Intervention Type DRUG

Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV

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.

Group Type EXPERIMENTAL

Isatuximab

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous

Carfilzomib

Intervention Type DRUG

Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Dexamethasone

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral

Dexamethasone IV

Intervention Type DRUG

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Montelukast

Intervention Type DRUG

Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral

Acetaminophen

Intervention Type DRUG

Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)

Diphenhydramine

Intervention Type DRUG

Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV

Methylprednisolone

Intervention Type DRUG

Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV

Interventions

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Isatuximab

Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous

Intervention Type DRUG

Carfilzomib

Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Intervention Type DRUG

Dexamethasone

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral

Intervention Type DRUG

Dexamethasone IV

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

Intervention Type DRUG

Montelukast

Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral

Intervention Type DRUG

Acetaminophen

Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)

Intervention Type DRUG

Diphenhydramine

Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV

Intervention Type DRUG

Methylprednisolone

Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV

Intervention Type DRUG

Other Intervention Names

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Kyprolis

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* 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 \<9 months before first isatuximab administration or randomization as applicable or, b) Intolerant to the anti-CD38 previously received
* Prior treatment with 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
* Uncontrolled or active infection with hepatitis A, B, and C virus; known acquired immunodeficiency syndrome (AIDS)-related illness; active primary amyloid light chain (AL) amyloidosis
* Any severe acute or chronic medical condition which could impair the ability of the participant to participate in the study or interfere with interpretation of study results (eg, systemic infection unless specific anti-infective therapy is employed) or participant unable to comply with the study procedures.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number : 0360002

Wollongong, New South Wales, Australia

Site Status

Investigational Site Number : 0360001

Melbourne, Victoria, Australia

Site Status

Hospital Mae de Deus Site Number : 0760002

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Clinica São Germano- Site Number : 0760003

São Paulo, , Brazil

Site Status

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001

São Paulo, , Brazil

Site Status

Investigational Site Number : 1560006

Changsha, , China

Site Status

Investigational Site Number : 1560002

Guangzhou, , China

Site Status

Investigational Site Number : 1560005

Nanchang, , China

Site Status

Investigational Site Number : 1560004

Shenyang, , China

Site Status

Investigational Site Number : 1560001

Tianjin, , China

Site Status

Investigational Site Number : 1560007

Tianjin, , China

Site Status

Investigational Site Number : 1560003

Wuhan, , China

Site Status

Investigational Site Number : 2030002

Brno, , Czechia

Site Status

Investigational Site Number : 2030004

Olomouc, , Czechia

Site Status

Investigational Site Number : 2030003

Ostrava, , Czechia

Site Status

Investigational Site Number : 2030001

Prague, , Czechia

Site Status

Investigational Site Number : 3000001

Athens, , Greece

Site Status

Investigational Site Number : 3000002

Athens, , Greece

Site Status

Investigational Site Number : 3920001

Kashiwa, Chiba, Japan

Site Status

Investigational Site Number : 3920002

Okayama, , Japan

Site Status

Investigational Site Number : 6200001

Braga, , Portugal

Site Status

Investigational Site Number : 6200004

Lisbon, , Portugal

Site Status

Investigational Site Number : 6200005

Lisbon, , Portugal

Site Status

Countries

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Australia Brazil China Czechia Greece Japan Portugal

References

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Parmar G, Capra M, Seguro F, Hungria V, Dimopoulos MA, Delimpasi S, Minarik J, Spicka I, Pour L, Marques H, Esteves G, Sunami K, Yuda J, Hajek R, Mihalyova J, Soufflet C, Yu D, Benlhassan K, Koch V, Comerford E, Cordero P, Suzan F, Quach H. Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma: results of the Phase 2 study IZALCO. Blood Cancer J. 2025 Dec 27. doi: 10.1038/s41408-025-01436-0. Online ahead of print.

Reference Type DERIVED

PMID: 41455697 (View on PubMed)

Other Identifiers

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U1111-1280-5090

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-508870-27

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACT17453

Identifier Type: -

Identifier Source: org_study_id