AzTrials
AzTrials

MyelomaPhase 3IFM/DFCI2009NCT01191060

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

A Phase 3 study testing Lenalidomide, Bortezomib in people with Myeloma, run by University Hospital, Toulouse at 68 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

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Myeloma
What is being tested?
Lenalidomide, Bortezomib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
68 sitesFrance
Study dates
Oct 2010to 30 Nov 2018
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

  • (with labs performed within 21 days of initiation of protocol therapy):
  • Patients diagnosed with multiple myeloma based on International Myeloma Foundation 2003 Diagnostic Criteria.
  • Patients must have symptomatic myeloma with myeloma-related organ damage.
  • Patients must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains.
  • Age between 18 and 65 years at the time of signing the informed consent document.
  • ECOG performance status <2 (Karnofsky ≥ 60%)
  • Negative HIV blood test

Who cannot join

  • Participants must not have been treated with any prior systemic therapy for multiple myeloma. Treatment by localized radiotherapy is not an exclusion criterion if an interval of at least two weeks between the end of radiotherapy and initiation of protocol therapy entry in the study is observed. Similarly, the dose of corticosteroids received by the participant should not exceed the equivalent of 160 mg of dexamethasone over a two-week period before initiation of protocol therapy.
  • Primary amyloidosis (AL) or myeloma complicated by amylosis.
  • Participants may not be receiving any other study investigational agents.
  • Participants with known brain metastases
  • Poor tolerability or known allergy to any of the study drugs or compounds of similar chemical or biologic composition to study agents
  • Platelet count < 50,000/mm3 per µLwithin 21 days of initiation of protocol therapy. Transfusion within 7 days of screening is not allowed to meet platelet eligibility criteria.
Show all 18Show fewer
  • ANC < 1,000 cells/mm3 within 21 days of initiation of protocol therapy. Growth factor within 7 days of screening is not allowed to meet ANC eligibility criteria.
  • Hemoglobin < 8.0 g/dL within 21 days of initiation of protocol therapy. Transfusion may be used to meet hemoglobin eligibility criteria.
  • Hepatic impairment, defined a bilirubin > 1.5 x institutional upper limit of normal (ULN) > 2 mg/dL (Patients with benign hyperbilirubinemia (e.g., Gilbert's syndrome) are eligible) and or AST (SGOT), or ALT (SGPT), or alkaline phosphatase > 2 x ULN
  • Renal insufficiency, defined as serum creatinine > 2.5 mg/dl and/or creatinine clearance < <40 60 ml/min (actual or calculated). The Cockgroft-Gault formula should be used for calculating creatinine clearance values, and may be located in Section 4.2
  • Respiratory compromise, defined as ventilation tests and with DLCO < 50%
  • Participant must not demonstrate with clinical signs of heart or coronary failure, or evidence of LVEF < 40%. Participant must not have with myocardial infarction within 6 months prior to enrollment or have New York Heart Association (NYHA Appendix VII) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
  • Intercurrent illness including, but not limited to ongoing or active severe infection, known (active or not) infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements.
  • Participant with previous history of another malignant condition, except for basal cell carcinoma and stage I cervical cancer
  • Female participant who is pregnant or breast-feeding
  • Inability to comply with an anti-thrombotic treatment regimen
  • Peripheral neuropathy ≥ Grade 2 peripheral neuropathy on clinical examination within 21 days of initiation of protocol therapy
  • Mental illness likely to interfere with participation in the study and Adults under juridical protection

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

France68 sites

  • CH du Pays D'Aix

    Aix-en-Provence, 13 616

  • CHRU - Hôpital Sud Amiens

    Amiens, 80054

  • CHU d'Angers

    Angers, 49033

  • Centre Hospitalier Argenteuil Victor Dupouy

    Argenteuil, 95 100

  • Centre Hospitalier H.Duffaut

    Avignon, 84902

  • Centre Hospitalier de la côte basque

    Bayonne, 64109

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Centre Hospitalier de Blois

    Blois, 41016

  • Hôpital Avicenne

    Bobigny, 93009

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33 300

  • Hôpital A.Morvan

    Brest, 29609

  • CHU Caen Côte de Nacre

    Caen, 14033

  • Centre François Baclesse

    Caen, 14076

  • CH René Dubos

    Cergy-Pontoise, 95303

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, 71 321

  • CH Chambéry

    Chambéry, 73011

  • Hôpital Antoine Béclère

    Clamart, 92 141

  • Hôpital d'instruction des armées Percy

    Clamart, 92141

  • CHU d'Estaing

    Clermont-Ferrand, 63000

  • Pole Santé République

    Clermont-Ferrand, 63050

  • CH Louis Pasteur - Colmar

    Colmar, 68024

  • CH Sud Francilien

    Corbeil-Essonnes, 91106

  • CHU Henri Mondor

    Créteil, 94 010

  • CHRU Dijon

    Dijon, 21000

  • Centre Hospitalier Général - Dunkerque

    Dunkirk, 59 385

  • Hôpital A.Michallon

    Grenoble, 38043

  • Centre hospitalier départemental - La Roche sur Yon cedex

    La Roche-sur-Yon, 85025

  • CH de Chartres - Hôpital Louis Pasteur

    Le Coudray, 26630

  • Centre Jean Bernard

    Le Mans, 72000

  • Centre hospitalier Le Mans

    Le Mans, 72037

  • CHRU - Hôpital Claude Huriez

    Lille, 59037

  • CHU de Limoges

    Limoges, 87042

  • Centre hospitalier Bodelio

    Lorient, 56322

  • CHU - Hôpital Edouard Herriot

    Lyon, 69437

  • Centre Léon Bérard

    Lyon

  • Institut Paoli Calmettes

    Marseille, 13273

  • CH Meaux

    Meaux, 77104

  • Hopital E Muller

    Mulhouse, 68100

  • Hôpitaux de Brabois

    Nancy, 54511

  • Centre Catherine de Sienne

    Nantes, 44 202

  • CHRU - Hôtel Dieu

    Nantes, 44093

  • Hôpital Archet 1

    Nice, 06202

  • Hôpital de l'Archet

    Nice, 06202

  • Groupe Hospitalo-Universitaire Carémeau

    Nîmes Cédex 9, 30029

  • Institut Curie

    Paris, 75005

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Saint-Louis

    Paris, 75475

  • Hôpital St-Antoine

    Paris, 75571

  • 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

  • Centre Hospitalier de la région d'Annecy

    Pringy, 74374

  • Hôpital R.Debré

    Reims, 51092

  • CHRU - Hôpital de Pontchaillou

    Rennes, 35033

  • CHRU - Hôpital Sud

    Rennes, 35056

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Hospitalier Yves le Foll

    Saint-Brieuc, 22 027

  • Centre René Huguenin

    Saint-Cloud, 92210

  • Centre Hospitalier Départemental - La réunion St Denis

    Saint-Denis, 97 405

  • Groupe Hospitalier Sud Réunion

    Saint-Pierre, 97448

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42 271

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091

  • University Hospital of Toulouse, Purpan

    Toulouse, 31059 Cedex 9

  • CHRU - Hôpital Bretonneau

    Tours, 37044

  • Centre Hospitalier de Valence

    Valence, 26953

  • CH Bretagne Atlantique Vannes et Auray

    Vannes, 56017

  • Institut Gustave Roussy

    Villejuif, 94 805

Other trials in France

About this study

Official title: 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

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).

Read the detailed description

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).

Conditions
Myeloma
Being tested
Lenalidomide, Bortezomib
Keywords
Progression free survival prolongation, Disease Progression, Overall survival
Medical subject headings
Neoplasms, Plasma Cell, Disease Progression

What participants receive

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

  • Lenalidomide, BortezomibDrug

    Also called Lenalidomide (REVLIMID®), Bortezomib (VELCADE®)

    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, BortezomibDrug

    Also called Lenalidomide (REVLIMID®), Bortézomib (VELCADE®)

    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

Study groups in NCT01191060
Study groupRoleWhat they receive
lenalidomide, bortezomib with ASCTExperimentalRVD 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)
Receives: Drug: Lenalidomide, Bortezomib
lenalidomide, bortezomib without ASCTExperimentalRVD 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)
Receives: Drug: Lenalidomide, Bortezomib

What is being measured

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

  1. Progression Free Survival

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

    Measured: up to 4 years

Secondary outcomes (5)

  1. Response Rates

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

    Measured: up to 4 years

  2. Time To Progression

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

    Measured: up to 4 years

  3. Toxicity comparison

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

    Measured: up to 4 years

  4. Genetic prognostic groups definition

    Genetic prognostic groups definition (evaluated by gene expression profiling-GEP) from randomization up to 4 years or until progression

    Measured: up to 4 years

  5. Best treatment examination in each GEP-defined prognostic group.

    Best treatment examination in each GEP-defined prognostic group. from randomization up to 4 years or until progression

    Measured: up to 4 years

Timeline

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

  1. First posted30 Aug 2010 (estimated)
  2. Study startOct 2010
  3. Primary completion30 Nov 2018
  4. Study completion30 Nov 2018

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
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01191060
Sponsor's protocol ID
09 110 01
Other IDs
2009-016871-32, 2009
Acronym
IFM/DFCI2009
Status last verified
Mar 2026
First submitted
16 Apr 2010
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Attal M, Lauwers-Cances V, Hulin C, Leleu X, Caillot D, Escoffre M, Arnulf B, Macro M, Belhadj K, Garderet L, Roussel M, Payen C, Mathiot C, Fermand JP, Meuleman N, Rollet S, Maglio ME, Zeytoonjian AA, Weller EA, Munshi N, Anderson KC, Richardson PG, Facon T, Avet-Loiseau H, Harousseau JL, Moreau P; IFM 2009 Study. Lenalidomide, Bortezomib, and Dexamethasone with Transplantation for Myeloma. N Engl J Med. 2017 Apr 6;376(14):1311-1320. doi: 10.1056/NEJMoa1611750.

    PubMed 28379796

  • 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

  • Noori S, Wijnands C, Langerhorst P, Bonifay V, Stingl C, Touzeau C, Corre J, Perrot A, Moreau P, Caillon H, Luider TM, Dejoie T, Jacobs JFM, van Duijn MM. Dynamic monitoring of myeloma minimal residual disease with targeted mass spectrometry. Blood Cancer J. 2023 Feb 24;13(1):30. doi: 10.1038/s41408-023-00803-z. No abstract available.

    PubMed 36828828

  • Langerhorst P, Noori S, Zajec M, De Rijke YB, Gloerich J, van Gool AJ, Caillon H, Joosten I, Luider TM, Corre J, VanDuijn MM, Dejoie T, Jacobs JFM. Multiple Myeloma Minimal Residual Disease Detection: Targeted Mass Spectrometry in Blood vs Next-Generation Sequencing in Bone Marrow. Clin Chem. 2021 Nov 26;67(12):1689-1698. doi: 10.1093/clinchem/hvab187.

    PubMed 34643690

  • Samur MK, Aktas Samur A, Fulciniti M, Szalat R, Han T, Shammas M, Richardson P, Magrangeas F, Minvielle S, Corre J, Moreau P, Thakurta A, Anderson KC, Parmigiani G, Avet-Loiseau H, Munshi NC. Genome-Wide Somatic Alterations in Multiple Myeloma Reveal a Superior Outcome Group. J Clin Oncol. 2020 Sep 20;38(27):3107-3118. doi: 10.1200/JCO.20.00461. Epub 2020 Jul 20.

    PubMed 32687451

  • Roussel M, Hebraud B, Hulin C, Perrot A, Caillot D, Stoppa AM, Macro M, Escoffre M, Arnulf B, Belhadj K, Karlin L, Garderet L, Facon T, Guo S, Weng J, Dhanasiri S, Leleu X, Moreau P, Attal M. Health-related quality of life results from the IFM 2009 trial: treatment with lenalidomide, bortezomib, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma. Leuk Lymphoma. 2020 Jun;61(6):1323-1333. doi: 10.1080/10428194.2020.1719091. Epub 2020 Feb 22.

    PubMed 32090636

  • Dunavin NC, Wei L, Elder P, Phillips GS, Benson DM Jr, Hofmeister CC, Penza S, Greenfield C, Rose KS, Rieser G, Merritt L, Ketcham J, Heerema N, Byrd JC, Devine SM, Efebera YA. Early versus delayed autologous stem cell transplant in patients receiving novel therapies for multiple myeloma. Leuk Lymphoma. 2013 Aug;54(8):1658-64. doi: 10.3109/10428194.2012.751528. Epub 2012 Dec 31.

    PubMed 23194056

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide, Bortezomib in people with Myeloma, run by University Hospital, Toulouse at 68 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 7 inclusion and 18 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 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?

Progression Free Survival (time frame: up to 4 years). 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 NCT01191060, which also lists 7 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 6 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in