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

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Velcade-Dexamethasone
* Drug: Velcade-Thalidomide-Dexamethasone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Velcade-Dexamethasone<br> | Drug: Velcade-Dexamethasone<br> <br> |
| Active Comparator: Velcade-Thalidomide-Dexamethasone<br> | Drug: Velcade-Thalidomide-Dexamethasone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newly Diagnosed, multiple myeloma, induction, Thalidomide