Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

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

Anti-Infective Agents

Cyclophosphamide

Dexamethasone

Bortezomib

Dexamethasone acetate

Thalidomide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Arm A:

1. Induction therapy 4 cycles of VTD (21 days) Thalidomide® 100 mg/day Per Os Day1 to Day21 Velcade® 1.3 mg/m²/day Subcutaneous Day1, 4, 8 and 11 Dexamethasone 40 mg/day Per Os Day 1 to 4 and Day 9 to 12
2. Systematic stem cell harvest after cycle 3 Mobilization: Cyclophosphamide and one week after the last dose of Thalidomide, stem cells have to be harvested

For arm B:

1. Induction therapy : 4 cycles of VCD (21 days)

   * Cyclophosphamide 500 mg/m²/day, Per Os Day 1, 8, 15
   * Velcade® and Dexamethasone identical treatment to Arm A
2. Systematic stem cell harvest after cycle 3 Mobilization: Cyclophosphamide and two weeks after the last dose of Cyclophosphamide, stem cells have to be harvested

Thalidomide®

Velcade®

Dexaméthasone

Philippe MOREAU

This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma.

Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD.

The patient population will consist of adult men and women who have a confirmed diagnosis of Multiple Myeloma and who meet eligibility criteria. They will be recruited from among the patients consulting in an investigating centre's haematology service for newly diagnosed, symptomatic, untreated multiple myeloma.

in each treatment arm there will be :

1. Induction therapy : 4 cycles of VTD (21 days)or VCD
2. Systematic stem cell harvest after cycle 3

Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)

A PHASE III STUDY OF VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) VERSUS VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA."

The detection and the estimation of the urinary monoclonal components is an inescapable element of the diagnosis and the evaluation of the therapeutic efficacy in the myeloma.

Urinary protein, electrophoresisin agarose gel is the quantitative method of choice. In these labs, the quantification of the urinary monoclonal peak is not performed. In the absence of quantitative data on urinary monoclonal components, the patient is considered as non-assessable. Recently, the company Sebia has developed the quantification on two other materials used specifically for the characterization of monoclonal component and / or proteinuria (HYDRAGEL BENCE JONES and HYDRAGEL URINE PROFILE).

The objective of this study is to compare the quantification of monoclonal components between the reference HR electrophoresis technique and the other two above-mentioned techniques.

compare the Response assessment in both arms: the Very good partial remission rate (according to the criteria IMWG) achieved with four courses of VTD with that achieved with four courses of VCD

compare the Response assessment in both arms: the following parameters after induction treatment with four courses of VTD or four courses of VCD the Complete remission rate (according to the criteria IMWG)

To evaluate the Safety of induction therapy

To evaluate Overall and Progression-Free Survival

compare the Response assessment in both arms: Compare the following parameters after induction treatment with four courses of VTD or four courses of VCD the Partial remission rate (according to the criteria IMWG)

Nantes University Hospital

Lenalidomide

Daratumumab

Induction 6 cycles 20/36 mg/m² on days 1, 2, 8, 9, 15, 16 (20 mg/m² on D1 and 2 cycle 1 only) Consolidation 4 cycles Carfilzomib 20 or 36 mg/m² on days 1, 2, 8, 9, 15, 16 (20 mg/m² on D1 and 2 first cycle only)

Carfilzomib

induction: 6 cycles Daratumumab 8/16mg/kg IV on Days 1, 8, 15, 22 for the first two cycle 2 and on days 1 and 15 for cycles 3 to 6. (8mg/kg on D1 \& D2 cycle 1 only) Consolidation: daratumumab 4 cycles 16mg/kg IV Day 1, Day 15 Maintenance Daratumumab 16mg/kg IV once every 8 weeks for 2 years (or until documented disease progression)

induction: 6 cycles Lenalidomide 25 mg/day from day 1 to day 21 Consolidation: 4 cycles 15 mg/day from Day 1 to Day 21 (first cycle ) 25 mg/day from Day 1 to Day 21 (in the following cycle) Maintenance therapy 10mg/day, Day 1 to 21, for 2 years (or until documented disease progression)

induction 6 cycles 20 mg/day on days 1-2, 8-9, 15-16 and 22-23 Consolidation 4 cycles 40 mg/Day on Days 1, 8, 15 and 22

According to international guidelines, upfront therapy for transplant eligible myeloma patients should include triplet induction containing proteasome inhibitor and immunomodulatory agent, autologous stem cell transplant, PI+Imid based triplet consolidation and lenalidomide maintenance. Despite this approach, virtually all MM patients experience disease relapse, especially those with High Risk disease defined by adverse cytogenetic abnormalities (i.e. del(17p), or t(14;16) or t(4;14)) detected by FISH and/or SNP arrays. Indeed, HR myeloma is associated with poorer progression free survival and overall survival and frontline therapy should therefore be improved for this subset of HR patients. The primary objective of this prospective multicenter, open label, interventional phase 2 trial is to evaluate the feasibility of an intensive program including quadruplet induction and consolidation, tandem autologous stem cell transplantation and maintenance in newly diagnosed multiple myeloma patients presenting with HR cytogenetic. Quadruplet induction and consolidation include carfilzomib, lenalidomide, dexamethasone and daratumumab. Maintenance will include lenalidomide and daratumumab. Secondary objectives will include efficacy parameters (i.e. response rate, minimal residual disease, safety, progression free survival, overall survival).

One group of subjects who must have documented Multiple Myeloma High Risk satisfying the CRAB and measurable disease.

An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients

An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients: a Phase II Study of the Intergroupe Francophone du Myélome "IFM 2018-04"

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)	NCT01971658	Multiple Myelom...	Thalidomide® Cyclophosphamid... Velcade® Dexaméthasone	18 Years - 65 Years	Nantes University Hospital
An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients	NCT03606577	Multiple Myelom...	Carfilzomib Daratumumab Lenalidomide Dexamethasone	18 Years - 65 Years	Nantes University Hospital
Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)	NCT01971658	Multiple Myelom...	Thalidomide® Cyclophosphamid... Velcade® Dexaméthasone	18 Years - 65 Years	Nantes University Hospital

Spots Global Cancer Trial Database for dexaméthasone