Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant

Phase 1

• Conditions: Plasma cell myeloma; MedDRA 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-BE
• Lead Sponsor: Sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-02
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

-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

Exclusion Criteria

-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