Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years (IFM/DFCI2009)
Myeloma
About this trial
This is an interventional treatment trial for Myeloma focused on measuring Progression free survival prolongation, Disease Progression, Overall survival
Eligibility Criteria
Inclusion Criteria for registration :
(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
Exclusion Criteria for registration (section 4.2):
- 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.
- 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
Sites / Locations
- CH du Pays D'Aix
- CHRU - Hôpital Sud Amiens
- CHU d'Angers
- Centre Hospitalier Argenteuil Victor Dupouy
- Centre Hospitalier H.Duffaut
- Centre Hospitalier de la côte basque
- Hôpital Jean Minjoz
- Centre Hospitalier de Blois
- Hôpital Avicenne
- Polyclinique Bordeaux Nord Aquitaine
- Hôpital A.Morvan
- CHU Caen Côte de Nacre
- Centre François Baclesse
- CH René Dubos
- Centre Hospitalier William Morey
- CH Chambéry
- Hôpital Antoine Béclère
- Hôpital d'instruction des armées Percy
- Pole Santé République
- CHU d'Estaing
- CH Louis Pasteur - Colmar
- CH Sud Francilien
- CHU Henri Mondor
- CHRU Dijon
- Centre Hospitalier Général - Dunkerque
- Hôpital A.Michallon
- Centre hospitalier départemental - La Roche sur Yon cedex
- CH de Chartres - Hôpital Louis Pasteur
- Centre Jean Bernard
- Centre hospitalier Le Mans
- CHRU - Hôpital Claude Huriez
- CHU de Limoges
- Centre hospitalier Bodelio
- CHU - Hôpital Edouard Herriot
- Centre Léon Bérard
- Institut Paoli Calmettes
- CH Meaux
- Hopital E Muller
- Hôpitaux de Brabois
- Centre Catherine de Sienne
- CHRU - Hôtel Dieu
- Hôpital Archet 1
- Hôpital de l'Archet
- Groupe Hospitalo-Universitaire Carémeau
- Hôpital Saint-Louis
- Hôpital St-Antoine
- Institut Curie
- Hôpital Cochin
- CH Saint Jean
- CHRU - Hôpital du Haut Lévêque
- Centre Hospitalier Lyon sud
- CHRU - Hôpital Jean Bernard
- Centre Hospitalier de la région d'Annecy
- Hôpital R.Debré
- CHRU - Hôpital de Pontchaillou
- CHRU - Hôpital Sud
- Centre Henri Becquerel
- Groupe Hospitalier Sud Réunion
- Centre René Huguenin
- Centre Hospitalier Yves le Foll
- Centre Hospitalier Départemental - La réunion St Denis
- Institut de Cancérologie de la Loire
- Hôpitaux Universitaires de Strasbourg
- University Hospital of Toulouse, Purpan
- CHRU - Hôpital Bretonneau
- Centre Hospitalier de Valence
- CH Bretagne Atlantique Vannes et Auray
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
lenalidomide, bortezomib with ASCT
lenalidomide, bortezomib without ASCT
RVD 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)
RVD 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)