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

NCT01971658 | Completed Phase 3

• 2 other identifiers: RC13_02842013-003174-27
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 63

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; Newly Diagnosed

Outcome Measures

Primary Outcomes (1)

• Response assessment according to the criteria IMWG

  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

  15-17 month

Secondary Outcomes (6)

• Response assessment according to the criteria IMWG

  15 - 17 month

• Number of Adverse Events

  15-17 month

• Number of collected stem cell

  17 month

• Number of death

  17 month

• Response assessment according to the criteria IMWG

  15-17 month

Other Outcomes (1)

• Comparison of three techniques for the quantification of urinary monoclonal components in patients with Newly Diagnosed Multiple Myeloma.

  17 month

Study Arms (2)

VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)

ACTIVE COMPARATOR

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

Drug: Thalidomide®; Drug: Velcade®; Drug: Dexaméthasone

VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD)

ACTIVE COMPARATOR

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

Drug: Cyclophosphamide; Drug: Velcade®; Drug: Dexaméthasone

Interventions

Thalidomide® DRUG

VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)

Cyclophosphamide DRUG

VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD)

Velcade® DRUG

VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD); VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)

Dexaméthasone DRUG

VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD); VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient
• \- 18 ≤ age \< 66 years
• \- Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2
• \- Patients must be eligible for Autologous Stem Cell Transplantation
• \- Patients must have measurable disease by serum M-protein ≥ 10 g/L and/or urine M-protein ≥200mg/day
• \- Female patients of child-bearing potential (FCBP):
• Must agree to have medically supervised pregnancy tests prior to starting study and every 21 days, including 4 weeks after the end of study treatment. This applies even if the patient practices complete and continued sexual abstinence.
• Must agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.
• \- Male Patients:
• Must agree to use a condom during sexual contact with a FCBP, throughout study drug therapy, during any dose interruption and for one week after discontinuation of study therapy
• Must agree to not donate semen during study drug therapy and for one week after discontinuation of study therapy
• \- All patients must:
• Agree to abstain from donating blood while taking study drug therapy and for one week after discontinuation of study drug therapy
• Agree not to share study medication with another person.
• \- Patients must be capable of giving informed consent

You may not qualify if:

• \- Asymptomatic Multiple myeloma
• \- Non-secretory Multiple myeloma
• \- Proven AL-amyloidosis
• \- Age ≥ 66 years old
• \- Prior or current systemic therapy for Multiple myeloma, including steroids (except for emergency use of a 4-day block of dexamethasone before randomization, maximum total dose allowed 160 mg)
• \- Radiation therapy in the 2 weeks preceding randomization
• \- National Cancer Institute grade ≥ 2 peripheral neuropathy
• \- Haemoglobin \< 8g/dL
• \- Absolute neutrophil count \< 1,000 cells / µL, platelet count \< 50,000 cells / µL
• \- Creatinine level \> 170 µmol/L or requiring dialysis.
• \- Bilirubin, transaminases or GamaGT \> 3 UNL (upper normal limit)
• \- Positive HIV serology, evidence of active Hepatitis B and C infection
• \- Severe active infection
• \- Inability to comply with an anti-thrombotic treatment regimen
• \- A personal medical history of severe psychiatric disease

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (63)

CHU Angers

Angers, Angers, 49033, France

Location

Hôpital Pitié-Salpétrière

Paris, Paris, 75651, France

Location

Centre Hospitalier de la région d'Annecy

Annecy, Pringy, 74374, France

Location

CHRU Hôpital Sud

Amiens, 80054, France

Location

Centre Hospitalier Argenteuil

Argenteuil, 95 100, France

Location

Centre Hospitalier H.Duffaut

Avignon, 84902, France

Location

Centre Hospitalier de la Côte Basque

Bayonne, 64109, France

Location

CHRU de Besançon

Besançon, 25030, France

Location

Hôpital Avicenne

Bobigny, 93009, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33 300, France

Location

Centre hospitalier Pierre Oudot

Bourgoin, 38300, France

Location

Hôpital A.Morvan

Brest, 29609, France

Location

CHU Caen Côte de Nacre

Caen, 14033, France

Location

CH René Dubos

Cergy-Pontoise, 95303, France

Location

Centre Hospitalier William Morey

Chalon/saone, 71 321, France

Location

Hôpital d'instruction des armées Percy

Clamart, 92141, France

Location

CHU d'Estaing

Clermont-Ferrand, 63000, France

Location

Hôpitaux civils de Colmar

Colmar, 68024, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

Location

CHU Henri Mondor

Créteil, 94 010, France

Location

CHRU Dijon

Dijon, 21000, France

Location

Centre Hospitalier Général

Dunkirk, 59 385, France

Location

CHRU - Hôpital A.Michallon

Grenoble, 38043, France

Location

Centre hospitalier départemental Vendée

La Roche-sur-Yon, 85925, France

Location

Hôpital Louis Pasteur

Le Coudray, 28000, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

CH Le Mans

Le Mans, 72000, France

Location

Hopital Saint Vincent de Paul

Lille, 59020, France

Location

CHRU - Hôpital Claude Huriez

Lille, 59037, France

Location

CHU de Limoges

Limoges, 87042, France

Location

Hôpital Du Scorff

Lorient, 56100, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Centre Hospitalier de Meaux

Meaux, 77104, France

Location

CHR Metz Thionville

Metz, 57085, France

Location

Centre Hospitalier intercommunale Meulan les mureaux

Meulan-en-Yvelines, 78250, France

Location

Hopital E Muller

Mulhouse, 68100, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Hôpital de l'Archet 1

Nice, 06202, France

Location

Groupe Hospitalo-Universitaire Carémeau

Nîmes, 30029, France

Location

Institut CURIE

Paris, 75005, France

Location

Hôpital Cochin

Paris, 75014, France

Location

CHU - Hôpital St-Antoine

Paris, 75571, France

Location

Hôpital Pitié-Salpétrière

Paris, 75651, France

Location

AP-HP Hôpital Necker

Paris, 75743, France

Location

CH Saint Jean

Perpignan, 66046, France

Location

CHRU - Hôpital du Haut Lévêque

Pessac, 33604, France

Location

Centre Hospitalier de PERIGUEUX

Périgueux, 24000, France

Location

Centre Hospitalier Lyon sud

Pierre-Bénite, 69495, France

Location

CHRU - Hôpital Jean Bernard

Poitiers, 86021, France

Location

Hôpital R.Debré

Reims, 51092, France

Location

CHRU - Hôpital de Pontchaillou

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Hospitalier Yves le Foll

Saint-Brieuc, 22 027, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42 271, France

Location

Centre Hospitalier

Saint-Quentin, 02 321, France

Location

Centre hospitalier

St-Malo, 35400, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

CHRU - Hôpital Purpan

Toulouse, 31059, France

Location

CHRU - Hôpital Bretonneau

Tours, 37044, France

Location

CHRU - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

CH Bretagne Atlantique Vannes et Auray

Vannes, 56017, France

Location

Related Publications (1)

• Rosinol L, Hebraud B, Oriol A, Colin AL, Rios Tamayo R, Hulin C, Blanchard MJ, Caillot D, Sureda A, Hernandez MT, Arnulf B, Mateos MV, Macro M, San-Miguel J, Belhadj K, Lahuerta JJ, Garelik MB, Blade J, Moreau P. Integrated analysis of randomized controlled trials evaluating bortezomib + lenalidomide + dexamethasone or bortezomib + thalidomide + dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma. Front Oncol. 2023 Nov 2;13:1197340. doi: 10.3389/fonc.2023.1197340. eCollection 2023.

  PMID: 38023148 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thalidomide; Cyclophosphamide; Bortezomib; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Philippe MOREAU

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 29, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

FR (63)