Thalidomide 100 mg/Day Versus Thalidomide 400 mg/Day in Relapse Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00657488
First received: April 7, 2008
Last updated: September 22, 2008
Last verified: September 2008
  Purpose

The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or relapsed multiple myeloma after at least two courses of treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the safety of the treatment.


Condition Intervention Phase
Multiple Myeloma
Drug: Thalidomide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Randomized Study Comparing the Efficacy and Safety of Two Doses of Thalidomide (100 mg/Day Versus 400 mg/Day) in the Treatment of Subjects With Refractory or Relapsed Multiple Myeloma.

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate [ Time Frame: monthly ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: December 2001
Study Completion Date: April 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Thalidomide 100mg/day. Dexamethasone is administered at a dose of 40 mg/d, on 4 consecutive days (D1 - D4), with one course every four week in case of stable disease after 12 weeks of treatment or in case of Disease Progression
Drug: Thalidomide
Thalidomide 100mg/day or 400 mg/day at bed time during one year
Other Name: THALOMID
Active Comparator: B
Thalidomide 400mg/day. Dexamethasone is administered at a dose of 40 mg/d, on 4 consecutive days (D1 - D4), with one course every four week in case of stable disease after 12 weeks of treatment or in case of Disease Progression
Drug: Thalidomide
Thalidomide 100mg/day or 400 mg/day at bed time during one year
Other Name: THALOMID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient over 18 years who has been informed about the potential risks and side effects of the treatment and having signed an informed consent to take part in the various aspects of the study.
  • Having a refractory or relapsed multiple myeloma after at least two courses of treatment.
  • The patients with a refractory or relapsed multiple myeloma after a single course of treatment that included an alkylating drug, can be included if there is no alternative treatment.
  • Concerning the thalidomide: Agreement to use and introduction of effective contraception by all the patients:

    1. For women of childbearing potential

      • Oral estroprogestogen contraception introduced at least 1 month before the first administration of thalidomide, and continued until the first menstruation following the end of the treatment, and their partners use a condom.
      • Qualitative serum test for beta-HCG negative: to be done on Day 2 or 3 of the menstrual cycle just before the 1st prescription of thalidomide; in a context of spaniomenorrhea or amenorrhea the test should be done within 3 days after the 1st prescription of thalidomide.
    2. For post-menopausal women

      • 1st situation: Known sterility due to:

        • total hysterectomy;
        • total ovariectomy;
        • total salpingectomy
      • 2nd situation: Natural menopause

        • amenorrhea for at least 1 year and
        • negative progestagen test and
        • plasma FSH > 50 IU/l
    3. For men: Throughout the duration of the treatment and for 3 months after the end of the protocol (i.e. one spermatogenesis cycle), sexual intercourse must always be protected by using a condom.

Exclusion Criteria:

  • Pregnant or breast-feeding women or those of childbearing potential who are not using an effective method of contraception or the lack of protection during sexual intercourse in men.
  • Patients who have already received treatment with thalidomide.
  • Contraindication to thalidomide.
  • Patient who has an absolute contraindication to dexamethasone.
  • Patient with a history of deep vein thrombosis and who is not taking effective oral anticoagulation (the anticoagulant must be continued throughout the entire study).
  • Performance index more than or equal to 3, unless the patient is bedridden as a result of the progress of the myeloma.
  • Any situations that do not permit adequate follow-up of the study.
  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: NCT00657488

  Show 49 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Ibrahim YAKOUB-AGHA, MD CHRU Lille
  More Information

No publications provided

Responsible Party: Robert Zerbib, Manager Clinical Programs, Pharmion
ClinicalTrials.gov Identifier: NCT00657488     History of Changes
Other Study ID Numbers: LATH0102/IFM0102
Study First Received: April 7, 2008
Last Updated: September 22, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Celgene Corporation:
Multiple Myeloma, Thalidomide, dose, dexamethasone

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
Thalidomide
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014