Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant
- Conditions
- Plasma cell myelomaMedDRA version: 21.1Level: PTClassification code 10035226Term: Plasma cell myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-002238-21-PT
- Lead Sponsor
- Sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 440
-Multiple myeloma (International Myeloma Working Group [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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method