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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


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

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

Study ID:

IFM 2007-02

NCT ID:

NCT00910897

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Newly Diagnosed
  • multiple myeloma
  • induction
  • Thalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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