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IFM 2008: Frontline Therapy in de Novo Multiple Myeloma Patients Under 65, (a Phase 2 Multicenter Trial)

Phase 2
18 Years
65 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

IFM 2008: Frontline Therapy in de Novo Multiple Myeloma Patients Under 65, (a Phase 2 Multicenter Trial)

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

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consent may be withdrawn by the subject at any time without prejudice to future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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of the best response after consolidation

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Michel ATTAL, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Toulouse


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

August 2009

Completion Date:

October 2012

Related Keywords:

  • Multiple Myeloma
  • De novo Multiple Myeloma
  • Bortezomib
  • Lenalidomide
  • induction therapy
  • consolidation therapy
  • maintenance therapy
  • High dose therapy
  • frontline therapy including new drugs and high dose therapy
  • Multiple Myeloma
  • Neoplasms, Plasma Cell