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Multiple MyelomaPhase 3IFM2013-04NCT01971658

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

A Phase 3 study testing Thalidomide®, Cyclophosphamide and Velcade® in people with Multiple Myeloma, run by Nantes University Hospital at 62 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Thalidomide®, Cyclophosphamide and Velcade®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
358 participants
Where
62 sitesFrance
Study dates
Oct 2013to Aug 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
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  • 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
  • - Patients must be affiliated with French social security system

Who cannot join

  • - 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
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  • - 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
  • - Uncontrolled diabetes contraindicating the use of high-dose dexamethasone
  • - Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment)
  • - A personal medical history of cancer unless the patient has been without relapse after treatment discontinuation > or = 5 years (except for basocellular skin cancer or in situ cervical cancer)
  • - Use of any investigational drug in the 30 days preceding randomization
  • 22 - Pregnant or lactating women. 23 - Adults under juridical protection 24 - Known or suspected hypersensitivity to any of the study therapies or excipients 25 - Necessity of vaccination for yellow fever or with any other live vaccines

Trial locations and contacts

62 sites in 1 country.

62 sites in 1 country

France62 sites

  • CHRU Hôpital Sud

    Amiens, 80054

  • CHU Angers

    Angers, 49033

  • Centre Hospitalier de la région d'Annecy

    Annecy, Pringy, 74374

  • Centre Hospitalier Argenteuil

    Argenteuil, 95 100

  • Centre Hospitalier H.Duffaut

    Avignon, 84902

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109

  • CHRU de Besançon

    Besançon, 25030

  • Hôpital Avicenne

    Bobigny, 93009

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33 300

  • Centre hospitalier Pierre Oudot

    Bourgoin, 38300

  • Hôpital A.Morvan

    Brest, 29609

  • CHU Caen Côte de Nacre

    Caen, 14033

  • CH René Dubos

    Cergy-Pontoise, 95303

  • Centre Hospitalier William Morey

    Chalon/saone, 71 321

  • Hôpital d'instruction des armées Percy

    Clamart, 92141

  • CHU d'Estaing

    Clermont-Ferrand, 63000

  • Hôpitaux civils de Colmar

    Colmar, 68024

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100

  • CHU Henri Mondor

    Créteil, 94 010

  • CHRU Dijon

    Dijon, 21000

  • Centre Hospitalier Général

    Dunkirk, 59 385

  • CHRU - Hôpital A.Michallon

    Grenoble, 38043

  • Centre hospitalier départemental Vendée

    La Roche-sur-Yon, 85925

  • Hôpital Louis Pasteur

    Le Coudray, 28000

  • Centre Jean Bernard

    Le Mans, 72000

  • CH Le Mans

    Le Mans, 72000

  • Hopital Saint Vincent de Paul

    Lille, 59020

  • CHRU - Hôpital Claude Huriez

    Lille, 59037

  • CHU de Limoges

    Limoges, 87042

  • Hôpital Du Scorff

    Lorient, 56100

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Paoli Calmettes

    Marseille, 13273

  • Centre Hospitalier de Meaux

    Meaux, 77104

  • CHR Metz Thionville

    Metz, 57085

  • Centre Hospitalier intercommunale Meulan les mureaux

    Meulan-en-Yvelines, 78250

  • Hopital E Muller

    Mulhouse, 68100

  • Nantes University Hospital

    Nantes, 44093

  • Hôpital de l'Archet 1

    Nice, 06202

  • Groupe Hospitalo-Universitaire Carémeau

    Nîmes, 30029

  • Institut CURIE

    Paris, 75005

  • Hôpital Cochin

    Paris, 75014

  • CHU - Hôpital St-Antoine

    Paris, 75571

  • Hôpital Pitié-Salpétrière

    Paris, 75651

  • AP-HP Hôpital Necker

    Paris, 75743

  • Centre Hospitalier de PERIGUEUX

    Périgueux, 24000

  • CH Saint Jean

    Perpignan, 66046

  • CHRU - Hôpital du Haut Lévêque

    Pessac, 33604

  • Centre Hospitalier Lyon sud

    Pierre-Bénite, 69495

  • CHRU - Hôpital Jean Bernard

    Poitiers, 86021

  • Hôpital R.Debré

    Reims, 51092

  • CHRU - Hôpital de Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Hospitalier Yves le Foll

    Saint-Brieuc, 22 027

  • Centre René Huguenin

    Saint-Cloud, 92210

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42 271

  • Centre Hospitalier

    Saint-Quentin, 02 321

  • Centre hospitalier

    St-Malo, 35400

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091

  • CHRU - Hôpital Purpan

    Toulouse, 31059

  • CHRU - Hôpital Bretonneau

    Tours, 37044

  • CHRU - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

  • CH Bretagne Atlantique Vannes et Auray

    Vannes, 56017

Other trials in France

About this study

Official title: 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."

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.

Read the detailed description

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
Being tested
Thalidomide®, Cyclophosphamide, Velcade®, Dexaméthasone
Keywords
Multiple myeloma, Newly Diagnosed
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01971658
Study groupRoleWhat they receive
VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)Active comparatorArm 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
Receives: Drug: Thalidomide®; Drug: Velcade®; Drug: Dexaméthasone
VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD)Active comparatorFor 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
Receives: Drug: Cyclophosphamide; Drug: Velcade®; Drug: Dexaméthasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 15-17 month

Secondary outcomes (6)

  1. Response assessment according to the criteria IMWG

    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)

    Measured: 15 - 17 month

  2. Number of Adverse Events

    To evaluate the Safety of induction therapy

    Measured: 15-17 month

  3. Number of collected stem cell

    Measured: 17 month

  4. Number of death

    To evaluate Overall and Progression-Free Survival

    Measured: 17 month

  5. Response assessment according to the criteria IMWG

    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)

    Measured: 15-17 month

  6. Number of relapse according to the criteria IMWG

    Progression-Free Survival

    Measured: 17 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01971658
Sponsor's protocol ID
RC13_0284
Other IDs
2013-003174-27
Acronym
IFM2013-04
Status last verified
Oct 2015
First submitted
30 Sep 2013
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No

Publications

  • Moreau P, Hulin C, Macro M, Caillot D, Chaleteix C, Roussel M, Garderet L, Royer B, Brechignac S, Tiab M, Puyade M, Escoffre M, Stoppa AM, Facon T, Pegourie B, Chaoui D, Jaccard A, Slama B, Marit G, Laribi K, Godmer P, Luycx O, Eisenmann JC, Allangba O, Dib M, Araujo C, Fontan J, Belhadj K, Wetterwald M, Dorvaux V, Fermand JP, Rodon P, Kolb B, Glaisner S, Malfuson JV, Lenain P, Biron L, Planche L, Caillon H, Avet-Loiseau H, Dejoie T, Attal M. VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial. Blood. 2016 May 26;127(21):2569-74. doi: 10.1182/blood-2016-01-693580. Epub 2016 Mar 21.

    PubMed 27002117

  • 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.

    PubMed 38023148

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Thalidomide®, Cyclophosphamide and Velcade® in people with Multiple Myeloma, run by Nantes University Hospital at 62 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response assessment according to the criteria IMWG (time frame: 15-17 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01971658, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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IFM2013-04 Clinical Trial NCT01971658 | AzTrials