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Phase 3
18 Years
65 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Inclusion Criteria:

- de novo myeloma

- according to Durie and Salmon classification stage II, III and stage I with a lytic
bone lesion

- patients from 18 to 65 years old

- beta2microglobulin < 3 mg/l or del13 absent

- signed informed consent

- eligible for transplantation

Exclusion Criteria:

- peripheral neurological toxicities

- uncontrolled or severe cardiovascular disease

- other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the

- patient who received biphosphonate during the last 60 days

- renal failure definited as creatinine > 150 µmol/l

- patient with obvious vascular cerebral medical history

- liver dysfunction definited as bilirubin > 35 µmol/l or ASAT, ALAT, PAL > 4N

- respiratory dysfunction

- HIV +

- Patient who refused to use an acceptable barrier method for contraception

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Duration of response

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

ATTAL Michel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Toulouse


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

Study ID:

PHRC 98-45-N



Start Date:

April 2000

Completion Date:

December 2009

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Autologous transplantation
  • Maintenance therapy
  • Thalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell