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Multiple Myeloma

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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

Dana-Farber Cancer Institute

Celgene Corporation

Janssen-Cilag Ltd.

University Hospital, Toulouse

3 induction cycles of bortezomib, lenalidomide and dexamethasone (VRD) followed by high dose melphalan and autologous stem cell transplantation.

Two months after haematological recovery, patients will receive 2 consolidation cycles of VRD and maintenance therapy for 1 year with lenalidomide.

Induction:

3 cycles of 21 days of Dexamethasone : 40 mg/j, days 1, 8 et 14 Bortezomib (Velcade®) : 1,3 mg/m2/d, days 1, 4, 8, et 11 Lenalidomide (Revlimid®) :25 mg/d, days 1 to 14

Consolidation (2 months After ASCT):

2 cycles of 21 days of Lenalidomide (Revlimid®) 25 mg/j, days 1 à 14 Bortezomib (Velcade®) 1,3 mg/m2/d, days 1, 4, 8, et 11 Dexamethasone 40 mg/j, days 1, 8 et 14

Maintenance Phase:

3 to 8 weeks after consolidation. Cycle length: 28 days Lenalidomide (Revlimid®) 10 mg/d until 12 months

Michel ATTAL, MD

The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone will increase the Complete Response (CR)/ very good partial response (VGPR) rate before and after High Dose Therapy (HDT) with ASCT.

Patients will receive 3 induction cycles of bortezomib, lenalidomide and dexamethasone (VRD) followed by high dose melphalan and autologous stem cell transplantation. Two months after haematological recovery, patients will receive 2 consolidation cycles of VRD and maintenance therapy for 1 year with lenalidomide

Frontline Therapy in de Novo Multiple Myeloma Patients Under 65

IFM2008: Frontline Therapy in de Novo Multiple Myeloma Patients Under 65, (a Phase 2 Multicenter Trial)

Evaluate the best response achieved , according to the IMWG uniform criteria, after consolidation treatment.

Evaluate the complete and very good partial response rates of the combination of bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients after 3 cycles.

Determine the safety and tolerability of the drug combination in this patient populations.

Evaluate the faisability and quality of the peripheral stem cells collection.

Evaluate the complete and very good partial response rates 2 months after HDT with ASCT and after 2 cycles of consolidation treatment.

Evaluate the progression free survival, the overall survival, time to progression and duration of response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years	NCT01191060	Myeloma	Lenalidomide, B... Lenalidomide, B...	18 Years - 65 Years	University Hospital, Toulouse
Frontline Therapy in de Novo Multiple Myeloma Patients Under 65	NCT01206205	Multiple Myelom...	Lenalidomide, B...	18 Years - 65 Years	University Hospital, Toulouse

Spots Global Cancer Trial Database for lenalidomide, bortezomib