Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)

Intergroupe Francophone du Myelome

Status and phase: Unknown; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Velcade-Thalidomide-Dexamethasone; Drug: Velcade-Dexamethasone

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00910897

Eudract 2007-005204-40

IFM 2007-02

Details and patient eligibility

About

Primary objective:

• Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.

Secondary objectives:

• Compare the following parameters following 4 cycles of VD or VTD induction treatment:

  • CR rate+ very good partial remission (VGPR) rate
  • Overall remission rate (CR + VGPR + partial remission (PR) rate)
  • K/l light chain ratio in patients in CR.
  • Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).

• Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).

Enrollment: 205 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed symptomatic multiple myeloma (MM) patient
• Aged under 65
• Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200 mg/day)
• Using effective contraceptive methods (for fertile men, women of childbearing potential)
• Provision of informed consent
• No evidence of active infection

Exclusion criteria

• Asymptomatic MM

• Non-secretory MM

• Aged 66 years or over

• ECOG performance status over 2 (see Appendix 2)

• Proven amyloidosis

• A personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer)

• Positive HIV serology

• A personal medical history of severe psychiatric disease

• Severe diabetes contraindicating the use of high-dose dexamethasone

• NCI grade ³ 2 peripheral neuropathy

• Serum clinical chemistry:

  • creatinine level > 300 µmol/L or requiring dialysis
  • bilirubin, transaminases or GamaGT > 3 the upper normal limit (UNL)

• Prior or current systemic therapy for MM, including steroids (except for emergency use of a 4-day block of dexamethasone between the screening phase and randomization)

• Radiation therapy in the 2 weeks preceding randomization

• A personal medical history of allergic reactions to compounds containing boron or mannitol

• Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) or NYHA class III or IV renal failure

• Use of any investigational drug in the 30 days preceding randomization

• Pregnant or lactating women; a serum Beta-hCG pregnancy test must be performed during the screening phase for female patients of childbearing potential

• Severe pulmonary troubles (including acute infiltrative pneumopathy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 2 patient groups

Velcade-Dexamethasone

Active Comparator group

Treatment:

Drug: Velcade-Dexamethasone

Velcade-Thalidomide-Dexamethasone

Active Comparator group

Treatment:

Drug: Velcade-Thalidomide-Dexamethasone