Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18 - 80
Clinical summary
Summary
In this trial participants will be randomized to one of three arms. In the first experimental arm, participants will receive induction treatment (4x6 week cycles) with intravenous (IV) isatuximab + subcutaneous (SC) bortezomib + oral lenalidomide + IV or oral dexamethasone, followed by continuous treatment (4-week cycles) with IV isatuximab + oral lenalidomide + IV or oral dexamethasone. In the second comparator arm, participants will receive induction treatment (4x6-week cycles) with SC bortezomib + oral lenalidomide + IV or oral dexamethasone, followed by continuous treatment (4-week cycles) with oral lenalidomide + IV or oral dexamethasone. In the third arm, participants will receive just 4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone.
Conditions
This trial is treating people with Multiple Myeloma
Eligibility
Inclusion
- Multiple myeloma (IMWG criteria).
- Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or patients < 65 years with comorbidities impacting possibility of transplant.
- Evidence of measurable disease.
- Written informed consent.
Exclusion
- Age < 18 years.
- Prior treatment for multiple myeloma.
- Any other prior or ongoing disease/health conditions incompatible with the study objectives.
- Organ function values not met.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ( PS) > 2.
- Hypersensitivity to the study medications.
- Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods.
- Male participants who disagree to follow the study contraceptive counseling.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Sanofi Aventis
Scientific Title
A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide (Revlimid®) and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant
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