Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years

Phase 3

Completed

• Conditions: Myeloma
• Interventions: Drug: Lenalidomide, Bortezomib

• Registration Number: NCT01191060
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Objective of this study is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs Progression-free survival (by at least 9 months).

Detailed Description

Study design Phase III, multicenter, randomized, open-label study designed to evaluate the clinical benefit from the drug combination RVD without immediate high-dose therapy (HDT) followed by lenalidomide maintenance (Arm A) versus RVD plus HDT and PBSCT followed by lenalidomide maintenance (Arm B).

Study Timeline

• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-08-27
• Study First Posted: 2010-08-30
• Study Start: 2010-10
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lenalidomide, bortezomib with ASCT	Lenalidomide, Bortezomib	RVD q 21 days (2 cycles) Collection of peripheral blood stem cells (PBSCs) using cyclophosphamide and GCSF (type Granocyte® or equivalent) Autologous stem cell transplant: Melphalan: infused over two days (day -2 and day -1) or as a single infusion (day-2) according to institutional practice Re-infusion of PBSCs RVD q 21 days (2 cycles) Maintenance Lenalidomide q28 days (12 months)
lenalidomide, bortezomib without ASCT	Lenalidomide, Bortezomib	RVD q 21 days (2 cycles) Collection of peripheral blood stem cells (PBSCs) using cyclophosphamide and GCSF (type Granocyte® or equivalent) RVD q 21 days (5 cycles) Maintenance Lenalidomide q28 days (12 months)

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	up to 4 years	To compare progression-free survival (PFS) between the Arm A and Arm B up to 4 years or until progression

Secondary Outcome Measures

Name	Time	Method
Genetic prognostic groups definition	up to 4 years	Genetic prognostic groups definition (evaluated by gene expression profiling-GEP) from randomization up to 4 years or until progression
Best treatment examination in each GEP-defined prognostic group.	up to 4 years	Best treatment examination in each GEP-defined prognostic group. from randomization up to 4 years or until progression
Response Rates	up to 4 years	-Response rates (RR) between the two arms up to 4 years or until progression
Time To Progression	up to 4 years	Time to progression (TTP) between the two arms up to 4 years or until progression
Toxicity comparison	up to 4 years	Toxicity comparison between the two arms randomization up to 4 years or until progression

Trial Locations

Locations (68)

CH du Pays D'Aix; 🇫🇷 Aix-en-provence, France

CHRU - Hôpital Sud Amiens; 🇫🇷 AMIENS cedex 1, France

CHU d'Angers; 🇫🇷 ANGERS cedex 01, France

Centre Hospitalier Argenteuil Victor Dupouy; 🇫🇷 Argenteuil, France

Centre Hospitalier H.Duffaut; 🇫🇷 Avignon, France

Centre Hospitalier de la côte basque; 🇫🇷 Bayonne, France

Hôpital Jean Minjoz; 🇫🇷 Besançon, France

Centre Hospitalier de Blois; 🇫🇷 Blois, France

Hôpital Avicenne; 🇫🇷 Bobigny, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

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