Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Disease Progression

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Cyclophosphamide

Dexamethasone

Melphalan

Lenograstim

Lenalidomide

Bortezomib

Dexamethasone acetate

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

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)

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)

Lenalidomide/Bortézomib/Dexamethasone cycles:

Number of cycles: 8 cycles for arm A

Cycle length

Dosage:

* Lenalidomide: 25 mg/day on days 1-14 of each cycle
* Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle

Maintenance phase (12 months):

Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed

Lenalidomide, Bortezomib

Lenalidomide Bortezomib Dexamethasone cycles:

Number of cycles: 5 cycles for arm B

Cycle length

Dosage:

* Lenalidomide: 25 mg/day on days 1-14 of each cycle
* Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle

Maintenance phase (12 months):

Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed

MICHEL ATTAL, MD PhD

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).

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

Randomized Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone to High-Dose Treatment With ASCT in the Initial Management of Myeloma in Patients up to 65 Years of Age

To compare progression-free survival (PFS) between the Arm A and Arm B up to 4 years or until progression

-Response rates (RR) between the two arms up to 4 years or until progression

Time to progression (TTP) between the two arms up to 4 years or until progression

Toxicity comparison between the two arms randomization up to 4 years or until progression

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. from randomization up to 4 years or until progression

Spots Global Cancer Trial Database for progression free survival prolongation