Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Cemiplimab

Lenalidomide

Pomalidomide

Dexamethasone acetate

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Immunological

Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the patient received on the parental protocol

Route of administration: IV infusion Pharmaceutical form: Vial

Isatuximab IV (SAR650984)

Cemiplimab (SAR439684)

Route of administration: Oral Pharmaceutical form: Tablets

Route of administration: Oral Pharmaceutical form: Capsules

Route of administration: Oral Pharmaceutical form: Hard capsules

Route of administration: SC injection with the investigational isatuximab injector device Pharmaceutical form: Vial

Isatuximab SC (SAR650984)

Trial Transparency email recommended (Toll free for US & Canada)

Clinical Sciences & Operations

* This is a multi-center, open-label, Phase 2 treatment extension study in patients with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study.
* This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study.
* The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

Participants can continue the treatment until disease progression, unacceptable adverse events, participant wish to discontinue study treatment, study treatment is commercially available and reimbursed in participant's country, or for any other reason, whichever comes first. The overall study duration will be of approximately 42 months.

International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

International, Multi-center, Open-label, Treatment Extension Study in Patients With Multiple Myeloma Who Are Still Benefitting From Isatuximab-based Therapy Following Completion of a Phase 1, 2, or 3 Parental Study

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Sanofi

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab	NCT05669989	Plasma Cell Mye...	Isatuximab IV (... Cemiplimab (SAR... Dexamethasone Lenalidomide Pomalidomide Isatuximab SC (...	18 Years -	Sanofi
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab	NCT05669989	Plasma Cell Mye...	Isatuximab IV (... Cemiplimab (SAR... Dexamethasone Lenalidomide Pomalidomide Isatuximab SC (...	18 Years -	Sanofi

Spots Global Cancer Trial Database for isatuximab iv (sar650984)