Frontline Therapy in de Novo Multiple Myeloma Patients Under 65

NCT01206205 | Completed Phase 2 DMC

• 1 other identifier: 0805603
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone will increase the Complete Response (CR)/ very good partial response (VGPR) rate before and after High Dose Therapy (HDT) with ASCT.

Conditions

Multiple Myeloma

Keywords

De novo Multiple Myeloma; Bortezomib; Lenalidomide; induction therapy; consolidation therapy; maintenance therapy; High dose therapy; frontline therapy including new drugs and high dose therapy

Outcome Measures

Primary Outcomes (1)

• Evaluation of the best response after consolidation

  Evaluate the best response achieved , according to the IMWG uniform criteria, after consolidation treatment.

  6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

Secondary Outcomes (5)

• Response Evaluation after 3 cycles

  6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

• Safety and tolerability : number and nature of Adverse Events

  6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

• Stem Cells Collection

  6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

• Response After HDT-ASCT and 2 cycles

  6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

• Progression Free Survival

  6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

Study Arms (1)

Lenalidomide, Bortezomib

EXPERIMENTAL

3 induction cycles of bortezomib, lenalidomide and dexamethasone (VRD) followed by high dose melphalan and autologous stem cell transplantation. Two months after haematological recovery, patients will receive 2 consolidation cycles of VRD and maintenance therapy for 1 year with lenalidomide.

Drug: Lenalidomide, Bortezomib

Interventions

Lenalidomide, Bortezomib DRUG

Induction: 3 cycles of 21 days of Dexamethasone : 40 mg/j, days 1, 8 et 14 Bortezomib (Velcade®) : 1,3 mg/m2/d, days 1, 4, 8, et 11 Lenalidomide (Revlimid®) :25 mg/d, days 1 to 14 Consolidation (2 months After ASCT): 2 cycles of 21 days of Lenalidomide (Revlimid®) 25 mg/j, days 1 à 14 Bortezomib (Velcade®) 1,3 mg/m2/d, days 1, 4, 8, et 11 Dexamethasone 40 mg/j, days 1, 8 et 14 Maintenance Phase: 3 to 8 weeks after consolidation. Cycle length: 28 days Lenalidomide (Revlimid®) 10 mg/d until 12 months

Also known as: Lenalidomide (REVLIMID®), Bortezomib (VELCADE®)

Lenalidomide, Bortezomib

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 diagnosed with multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria
• Subjects must have symptomatic myeloma or asymptomatic myeloma with myeloma-related organ damage
• Subjects must have measurable disease requiring systemic therapy.
• Male or female subject 18 years of age or older
• Karnofsky Performance Status score of ≥50% (Eastern Cooperative Oncology Group Performance Status score ≤2)
• Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to therapy. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (1 highly effective method and 1 additional effective method) used at the same time, beginning at least 4 weeks before initiation of Revlimid treatment. Women must also agree to ongoing pregnancy testing
• Men must agree to not father a child and agree to use a latex condom during therapy and for 4 weeks after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential.

You may not qualify if:

• Subjects must not have been treated previously with any systemic therapy for multiple myeloma. Prior treatment with corticosteroids or radiation therapy does not disqualify the subject (the maximum dose of corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in a 2-week period). Two weeks must have elapsed since the date of the last radiotherapy treatment. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 2 weeks have elapsed since the last date of therapy.
• AL amylo
• ≥Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment
• Renal insufficiency (serum creatinine \>2.5 mg/dL)
• Evidence of mucosal or internal bleeding and/or platelet refractory
• Platelet count \<70,000 per µL
• ANC \< 1000 cells/mm3
• AST or ALT greater than or equal to 2 x ULN
• Total bilirubin \>3 × ULN
• Myocardial infarction within 6 months prior to enrollment according to NYHY Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• Clinically relevant active infection or serious co-morbid medical conditions
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer
• Female subject who is pregnant or breast-feeding
• Serious medical or psychiatric illness likely to interfere with participation in study
• Uncontrolled diabetes mellitus

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Celgene Corporation: collaborator
• Janssen-Cilag Ltd.: collaborator

Study Sites (9)

Centre François Baclesse

Caen, 14076, France

Location

University Hospital of Dijon, Hôpital des Enfants

Dijon, 21000, France

Location

University Hospital of Grenoble, Hôpital A.Michallon, BP 217 X

Grenoble, 38043, France

Location

University Hospital Of Lille, Hôpital Claude Huriez

Lille, 59037, France

Location

Institut Paoli Calmette

Marseille, 13273, France

Location

University Hospital of Bordeaux, "Hôpital du Haut Lévêque "

Pessac, 33604, France

Location

University Hospital of Toulouse, Purpan

Toulouse, 31059, France

Location

Hôpital Bretonneau, Tours

Tours, 37044, France

Location

Hôpitaux de Brabois Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• Roussel M, Lauwers-Cances V, Robillard N, Hulin C, Leleu X, Benboubker L, Marit G, Moreau P, Pegourie B, Caillot D, Fruchart C, Stoppa AM, Gentil C, Wuilleme S, Huynh A, Hebraud B, Corre J, Chretien ML, Facon T, Avet-Loiseau H, Attal M. Front-line transplantation program with lenalidomide, bortezomib, and dexamethasone combination as induction and consolidation followed by lenalidomide maintenance in patients with multiple myeloma: a phase II study by the Intergroupe Francophone du Myelome. J Clin Oncol. 2014 Sep 1;32(25):2712-7. doi: 10.1200/JCO.2013.54.8164. Epub 2014 Jul 14.

  PMID: 25024076 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Bortezomib

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; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines

Study Officials

• Michel ATTAL, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 21, 2010
• Study Start: August 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

FR (9)