Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years
IFM/DFCI2009
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
1 other identifier
interventional
700
1 country
68
Brief 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. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs Progression-free survival (by at least 9 months).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2010
Longer than P75 for phase_3
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2010
CompletedFirst Posted
Study publicly available on registry
August 30, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedApril 18, 2019
April 1, 2019
8.2 years
April 16, 2010
April 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
To compare progression-free survival (PFS) between the Arm A and Arm B up to 4 years or until progression
up to 4 years
Secondary Outcomes (5)
Response Rates
up to 4 years
Time To Progression
up to 4 years
Toxicity comparison
up to 4 years
Genetic prognostic groups definition
up to 4 years
Best treatment examination in each GEP-defined prognostic group.
up to 4 years
Study Arms (2)
lenalidomide, bortezomib with ASCT
EXPERIMENTALRVD 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)
lenalidomide, bortezomib without ASCT
EXPERIMENTALRVD 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)
Interventions
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
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- 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.
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- Dana-Farber Cancer Institutecollaborator
- Celgene Corporationcollaborator
- Janssen-Cilag Ltd.collaborator
Study Sites (68)
CH du Pays D'Aix
Aix-en-Provence, 13 616, France
CHRU - Hôpital Sud Amiens
Amiens, 80054, France
CHU d'Angers
Angers, 49033, France
Centre Hospitalier Argenteuil Victor Dupouy
Argenteuil, 95 100, France
Centre Hospitalier H.Duffaut
Avignon, 84902, France
Centre Hospitalier de la côte basque
Bayonne, 64109, France
Hôpital Jean Minjoz
Besançon, 25030, France
Centre Hospitalier de Blois
Blois, 41016, France
Hôpital Avicenne
Bobigny, 93009, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33 300, France
Hôpital A.Morvan
Brest, 29609, France
CHU Caen Côte de Nacre
Caen, 14033, France
Centre François Baclesse
Caen, 14076, France
CH René Dubos
Cergy-Pontoise, 95303, France
Centre Hospitalier William Morey
Chalon-sur-Saône, 71 321, France
CH Chambéry
Chambéry, 73011, France
Hôpital Antoine Béclère
Clamart, 92 141, France
Hôpital d'instruction des armées Percy
Clamart, 92141, France
CHU d'Estaing
Clermont-Ferrand, 63000, France
Pole Santé République
Clermont-Ferrand, 63050, France
CH Louis Pasteur - Colmar
Colmar, 68024, France
CH Sud Francilien
Corbeil-Essonnes, 91106, France
CHU Henri Mondor
Créteil, 94 010, France
CHRU Dijon
Dijon, 21000, France
Centre Hospitalier Général - Dunkerque
Dunkirk, 59 385, France
Hôpital A.Michallon
Grenoble, 38043, France
Centre hospitalier départemental - La Roche sur Yon cedex
La Roche-sur-Yon, 85025, France
CH de Chartres - Hôpital Louis Pasteur
Le Coudray, 26630, France
Centre Jean Bernard
Le Mans, 72000, France
Centre hospitalier Le Mans
Le Mans, 72037, France
CHRU - Hôpital Claude Huriez
Lille, 59037, France
CHU de Limoges
Limoges, 87042, France
Centre hospitalier Bodelio
Lorient, 56322, France
CHU - Hôpital Edouard Herriot
Lyon, 69437, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, 13273, France
CH Meaux
Meaux, 77104, France
Hopital E Muller
Mulhouse, 68100, France
Hôpitaux de Brabois
Nancy, 54511, France
Centre Catherine de Sienne
Nantes, 44 202, France
CHRU - Hôtel Dieu
Nantes, 44093, France
Hôpital Archet 1
Nice, 06202, France
Hôpital de l'Archet
Nice, 06202, France
Groupe Hospitalo-Universitaire Carémeau
Nîmes Cédex 9, 30029, France
Institut Curie
Paris, 75005, France
Hôpital Cochin
Paris, 75014, France
Hôpital Saint-Louis
Paris, 75475, France
Hôpital St-Antoine
Paris, 75571, France
CH Saint Jean
Perpignan, 66046, France
CHRU - Hôpital du Haut Lévêque
Pessac, 33604, France
Centre Hospitalier Lyon sud
Pierre-Bénite, 69495, France
CHRU - Hôpital Jean Bernard
Poitiers, 86021, France
Centre Hospitalier de la région d'Annecy
Pringy, 74374, France
Hôpital R.Debré
Reims, 51092, France
CHRU - Hôpital de Pontchaillou
Rennes, 35033, France
CHRU - Hôpital Sud
Rennes, 35056, France
Centre Henri Becquerel
Rouen, 76038, France
Centre Hospitalier Yves le Foll
Saint-Brieuc, 22 027, France
Centre René Huguenin
Saint-Cloud, 92210, France
Centre Hospitalier Départemental - La réunion St Denis
Saint-Denis, 97 405, France
Groupe Hospitalier Sud Réunion
Saint-Pierre, 97448, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42 271, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
University Hospital of Toulouse, Purpan
Toulouse, 31059 Cedex 9, France
CHRU - Hôpital Bretonneau
Tours, 37044, France
Centre Hospitalier de Valence
Valence, 26953, France
CH Bretagne Atlantique Vannes et Auray
Vannes, 56017, France
Institut Gustave Roussy
Villejuif, 94 805, France
Related Publications (7)
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: 38023148DERIVEDNoori 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.
PMID: 36828828DERIVEDLangerhorst 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.
PMID: 34643690DERIVEDSamur 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.
PMID: 32687451DERIVEDRoussel 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.
PMID: 32090636DERIVEDAttal 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.
PMID: 28379796DERIVEDDunavin 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.
PMID: 23194056DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MICHEL ATTAL, MD PhD
University Hospital of Toulouse
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
April 16, 2010
First Posted
August 30, 2010
Study Start
October 1, 2010
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
April 18, 2019
Record last verified: 2019-04