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Completed

NCT Number: NCT00222053

IFM 99-02 Thalidomide in Myeloma

Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Médecine Interne, CHU Purpan, Toulouse, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 cervix
  • 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

Treatment and study plan

thalidomide

Drug

Per os thalidomide

biphosphonates

Drug

Biphosphonates

Primary outcomes

  1. Duration of response

    Time frame: 3 years

Secondary outcomes

  1. Survival

    Time frame: 3 years

  2. Toxicity

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Important dates

Study start
2000
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2005
Registry last updated
Apr 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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