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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Intergroupe Francophone du Myelome.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Intergroupe Francophone du Myelome
ClinicalTrials.gov Identifier:
NCT00910897
First received: May 29, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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).

Condition Intervention Phase
Multiple Myeloma
Drug: Velcade-Dexamethasone
Drug: Velcade-Thalidomide-Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Intergroupe Francophone du Myelome:

Enrollment: 205
Study Start Date: March 2008
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Velcade-Dexamethasone Drug: Velcade-Dexamethasone
Active Comparator: Velcade-Thalidomide-Dexamethasone Drug: Velcade-Thalidomide-Dexamethasone

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910897

  Show 56 Study Locations
Sponsors and Collaborators
Intergroupe Francophone du Myelome
  More Information

No publications provided by Intergroupe Francophone du Myelome

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Principal investigator: HAROUSSEAU Jean-Luc, University Hospital, Nantes
ClinicalTrials.gov Identifier: NCT00910897     History of Changes
Other Study ID Numbers: IFM 2007-02, Eudract 2007-005204-40
Study First Received: May 29, 2009
Last Updated: May 29, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Intergroupe Francophone du Myelome:
Newly Diagnosed
multiple myeloma
induction
Thalidomide

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on August 18, 2014