Frontline Therapy in de Novo Multiple Myeloma Patients Under 65 (IFM2008)

May 10, 2017 updated by: University Hospital, Toulouse

IFM2008: Frontline Therapy in de Novo Multiple Myeloma Patients Under 65, (a Phase 2 Multicenter Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will receive 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

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, cedex 5, France, 14076
        • Centre Francois Baclesse
      • Dijon, France, 21000
        • University Hospital of Dijon, Hôpital des Enfants
      • Grenoble Cedex 09, France, 38043
        • University Hospital of Grenoble, Hôpital A.Michallon, BP 217 X
      • Lille Cedex, France, 59037
        • University Hospital Of Lille, Hôpital Claude Huriez
      • Marseille Cedex, France, 13273
        • Institut Paoli Calmette
      • Pessac, France, 33604
        • University Hospital of Bordeaux, "Hôpital du Haut Lévêque "
      • Toulouse, France, 31059
        • University Hospital of Toulouse, Purpan
      • Tours Cedex, France, 37044
        • Hôpital Bretonneau, Tours
      • Vandoeuvre cedex, France, 54511
        • Hôpitaux de Brabois Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Known HIV infection
  • Known active hepatitis B or C viral infection
  • Known intolerance to steroid therapy
  • History of allergy to any of the study medications, their analogues, or excipients in the various formulations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lenalidomide, Bortezomib

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

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

Other Names:
  • Lenalidomide (REVLIMID®)
  • Bortezomib (VELCADE®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the best response after consolidation
Time Frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Evaluation after 3 cycles
Time Frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Evaluate the complete and very good partial response rates of the combination of bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients 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
Time Frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Determine the safety and tolerability of the drug combination in this patient populations.
6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Stem Cells Collection
Time Frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Evaluate the faisability and quality of the peripheral 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
Time Frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Evaluate the complete and very good partial response rates 2 months after HDT with ASCT and after 2 cycles of consolidation treatment.
6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Progression Free Survival
Time Frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Evaluate the progression free survival, the overall survival, time to progression and duration of response.
6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Celgene Corporation
Janssen-Cilag Ltd.

Investigators

  • Principal Investigator: Michel ATTAL, MD, University Hospital of Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 20, 2010

First Posted (Estimate)

September 21, 2010

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0805603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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