Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

NCT ID: NCT03275285

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2025-01-03

Brief Summary

The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.

Detailed Description

The duration of the study for a patient will include a period for screening of up to 3 weeks. Patients will be treated until disease progression, unacceptable AE, or patient decision to stop the study treatment. After study treatment discontinuation, patients will have follow-up visits until the analysis of overall survival.

Conditions

Plasma Cell Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Isatuximab + Carfilzomib + Dexamethasone (IKd)

Isatuximab (intravenous) on day 1, 8, 15 and 22 of 1st cycle, then on day 1 and 15 of subsequent cycles in combination with carfilzomib (intravenous) on day 1, 2, 8, 9, 15 and 16 + dexamethasone (intravenous or by mouth \[po\]) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.

Group Type: EXPERIMENTAL

isatuximab SAR650984

Intervention Type: DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

carfilzomib

Intervention Type: DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

dexamethasone

Intervention Type: DRUG

Pharmaceutical form: tablets or solution for infusion

Route of administration: oral or intravenous

Carfilzomib + Dexamethasone (Kd)

Carfilzomib (intravenous) on day 1, 2, 8, 9, 15, 16 + dexamethasone (intravenous or po) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.

Group Type: ACTIVE_COMPARATOR

carfilzomib

Intervention Type: DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

dexamethasone

Intervention Type: DRUG

Pharmaceutical form: tablets or solution for infusion

Route of administration: oral or intravenous

Interventions

isatuximab SAR650984

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Intervention Type: DRUG

carfilzomib

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Intervention Type: DRUG

dexamethasone

Pharmaceutical form: tablets or solution for infusion

Route of administration: oral or intravenous

Intervention Type: DRUG

Other Intervention Names

Sarclisa; Kyprolis

Eligibility Criteria

Inclusion Criteria

• Participants with MM previously treated with prior 1 to 3 lines and with measurable serum M-protein (>= 0.5 gram/deciliter) and/or urine M-protein (>= 200 milligram/24 hours).

Exclusion Criteria

• Participants previously pretreated with carfilzomib, who never achieved at least one minor response during previous therapies and/or last previous therapy completed within 14 last days.
• Participants with serum free light chain (FLC) measurable disease only.
• Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2.
• Participants with inadequate biological tests.
• Participants with myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or transient ischemic attack within last 6 months, and/or left ventricular ejection fraction lower than 40%.
• Participants with previous cancer unless disease free for more than 5 years or in situ cancer curatively treated.
• Participants with known acquired immunodeficiency syndrome related illness or human immunodeficiency virus requiring antiretroviral treatment, or hepatitis A, B, or C active infection.
• Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

UCSF MS Center Site Number : 8400002

San Francisco, California, United States

Spartanburg Medical Center Site Number : 8400003

Spartanburg, South Carolina, United States

Investigational Site Number : 0360005

Blacktown, New South Wales, Australia

Investigational Site Number : 0360006

Tweed Heads, New South Wales, Australia

Investigational Site Number : 0360002

Wollongong, New South Wales, Australia

Investigational Site Number : 0360001

Fitzroy, Victoria, Australia

Investigational Site Number : 0360004

Heidelberg West, Victoria, Australia

Investigational Site Number : 0360007

Nedlands, Western Australia, Australia

Investigational Site Number : 0360008

West Perth, Western Australia, Australia

Hospital Sao Rafael - Rede D'OR Sao Luiz Site Number : 0760005

Salvador, Estado de Bahia, Brazil

Hospital Mae de Deus Site Number : 0760003

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Amor - Hospital do Cancer de Barretos - Fundacao Pio XII Site Number : 0760001

Barretos, São Paulo, Brazil

Hospital das Clinicas de Sao Paulo Site Number : 0760002

São Paulo, São Paulo, Brazil

Instituto COI de Educacao e Pesquisa Site Number : 0760004

Rio de Janeiro, , Brazil

Investigational Site Number : 1240003

Surrey, British Columbia, Canada

Investigational Site Number : 1240001

Saint John, New Brunswick, Canada

Investigational Site Number : 1240002

Montreal, Quebec, Canada

Investigational Site Number : 2030002

Brno, , Czechia

Investigational Site Number : 2030004

Olomouc, , Czechia

Investigational Site Number : 2030003

Ostrava - Poruba, , Czechia

Investigational Site Number : 2030001

Prague, , Czechia

Investigational Site Number : 2500003

Lille, , France

Investigational Site Number : 2500001

Nantes, , France

Investigational Site Number : 2500006

Paris, , France

Investigational Site Number : 2500002

Pessac, , France

Investigational Site Number : 2500005

Pierre-Bénite, , France

Investigational Site Number : 2500004

Poitiers, , France

Investigational Site Number : 3000002

Athens, , Greece

Investigational Site Number : 3000005

Athens, , Greece

Investigational Site Number : 3000001

Athens, , Greece

Investigational Site Number : 3000004

Pátrai, , Greece

Investigational Site Number : 3000003

Thessaloniki, , Greece

Investigational Site Number : 3480003

Budapest, , Hungary

Investigational Site Number : 3480001

Budapest, , Hungary

Investigational Site Number : 3480004

Budapest, , Hungary

Investigational Site Number : 3480005

Kaposvár, , Hungary

Investigational Site Number : 3800003

Bologna, , Italy

Investigational Site Number : 3800001

Pisa, , Italy

Investigational Site Number : 3800004

Reggio Emilia, , Italy

Investigational Site Number : 3800002

Torino, , Italy

Investigational Site Number : 3920005

Shiwa-gun, Iwate, Japan

Investigational Site Number : 3920007

Kumamoto, Kumamoto, Japan

Investigational Site Number : 3920001

Suwa-shi, Nagano, Japan

Investigational Site Number : 3920003

Sunto-gun, Shizuoka, Japan

Investigational Site Number : 3920004

Shibuya-ku, Tokyo, Japan

Investigational Site Number : 3920006

Shinjuku-ku, Tokyo, Japan

Investigational Site Number : 3920002

Yamagata, , Japan

Investigational Site Number : 5540001

Auckland, , New Zealand

Investigational Site Number : 5540002

Wellington, , New Zealand

Investigational Site Number : 6430003

Kirov, , Russia

Investigational Site Number : 6430004

Novosibirsk, , Russia

Investigational Site Number : 6430002

Yekaterinburg, , Russia

Investigational Site Number : 4100006

Busan, Busan, South Korea

Investigational Site Number : 4100002

Gangnam-gu, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100005

Seoul, , South Korea

Investigational Site Number : 7240001

Badalona, Catalunya [Cataluña], Spain

Investigational Site Number : 7240005

Barcelona, Catalunya [Cataluña], Spain

Investigational Site Number : 7240002

Valencia, Valenciana, Comunidad, Spain

Investigational Site Number : 7240003

Madrid, , Spain

Investigational Site Number : 7240004

Seville, , Spain

Investigational Site Number : 7920003

Adana, , Turkey (Türkiye)

Investigational Site Number : 7920001

Ankara, , Turkey (Türkiye)

Investigational Site Number : 7920005

Bursa, , Turkey (Türkiye)

Investigational Site Number : 7920002

Istanbul, , Turkey (Türkiye)

Investigational Site Number : 7920004

Samsun, , Turkey (Türkiye)

Investigational Site Number : 8260004

Plymouth, Devon, United Kingdom

Investigational Site Number : 8260005

Leicester, Leicestershire, United Kingdom

Investigational Site Number : 8260001

Bristol, Somerset, United Kingdom

Countries

United States; Australia; Brazil; Canada; Czechia; France; Greece; Hungary; Italy; Japan; New Zealand; Russia; South Korea; Spain; Turkey (Türkiye); United Kingdom

References

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Reference Type: RESULT

PMID: 34097854 (View on PubMed)

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: DERIVED

PMID: 39067465 (View on PubMed)

Thoren K, Menad S, Nouadje G, Mace S. Isatuximab-Specific Immunofixation Electrophoresis Assay to Remove Interference in Serum M-Protein Measurement in Patients with Multiple Myeloma. J Appl Lab Med. 2024 Jul 1;9(4):661-671. doi: 10.1093/jalm/jfae028.

Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Martin T, Dimopoulos MA, Mikhael J, Yong K, Capra M, Facon T, Hajek R, Spicka I, Baker R, Kim K, Martinez G, Min CK, Pour L, Leleu X, Oriol A, Koh Y, Suzuki K, Casca F, Mace S, Risse ML, Moreau P. Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study. Blood Cancer J. 2023 May 9;13(1):72. doi: 10.1038/s41408-023-00797-8.

Reference Type: DERIVED

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Reference Type: DERIVED

PMID: 36108425 (View on PubMed)

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Reference Type: DERIVED

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1195-5957

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-001940-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC15246

Identifier Type: -

Identifier Source: org_study_id