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Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

This study has been completed.
Sponsor:
Information provided by:
Nordic Myeloma Study Group
ClinicalTrials.gov Identifier:
NCT00602511
First received: January 15, 2008
Last updated: February 8, 2011
Last verified: February 2011

January 15, 2008
February 8, 2011
October 2007
September 2010   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: Not specified ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00602511 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: Not specified ] [ Designated as safety issue: No ]
  • Response duration [ Time Frame: Not specified ] [ Designated as safety issue: No ]
  • Time to start of other treatment [ Time Frame: Not specified ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Not specified ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Not specified ] [ Designated as safety issue: No ]
  • Response rate after cross-over [ Time Frame: Not specified ] [ Designated as safety issue: No ]
  • Response duration after cross-over [ Time Frame: Not specified ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.

The study is an open randomized multicentre study in which patients with multiple myeloma refractory to melphalan therapy are randomized between bortezomib and thalidomide therapy, in both arms with the addition of dexamethasone. In case of failure to the initially given treatment the patient will be crossed over to the alternative treatment.

The number of patients needed is calculated to 300, based upon the hypothesis of a 50% difference in progression free survival, a significance level of 95% and a power of 80%. With 12 patients being recruited each month during 25 months and a 4 months follow-up after the last included patient, the total study time will be 29 months.

The dose regimens for bortezomib and thalidomide follow general clinical praxis as regards recommendations for optimal dosing in the Nordic countries.

Evaluation of response and toxicity is performed every 3 weeks for at least 12 weeks, thereafter every 6 weeks. Evaluation of efficacy is done according to The International Myeloma Working Group Uniform Response Criteria. Evaluation of toxicity is done by CTCAE grading. Evaluation of quality of life is done by the EORTC QLQ30 questionnaires with the addition of the myeloma specific MY-24 module which are mailed to the patients at predetermined intervals during the study.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Bortezomib

    Bortezomib 1,3 mg/m2 intravenously on days 1, 4, 8 och 11 of every 3 weeks cycle until maximal response, toxicity or maximum 8 cycles

    Dexamethasone 20 mg days 1-2, 4-5, 8-9 and 11-12 during the first 2 cycles, thereafter individualized dose depending on response and toxicity

  • Drug: Thalidomide

    Thalidomide 50 mg/day with dose escalation every 3 weeks until response or toxicity, maximal dose 200 mg/day

    Dexamethasone 40 mg/day day 1-4 every 3 weeks for at least 2 courses, thereafter individualized dose depending on response and toxicity

  • Active Comparator: 1
    Bortezomib - dexamethasone
    Intervention: Drug: Bortezomib
  • Experimental: 2
    Thalidomide - dexamethasone
    Intervention: Drug: Thalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treatment demanding multiple myeloma
  • Refractoriness to melphalan
  • Acceptance of rules for prevention of pregnancy

Exclusion Criteria:

  • Previous treatment with bortezomib, thalidomide, or lenalidomide
  • Sensory neuropathy grade III or neuropathic pain grade II
  • Severe concomitant disorder, e.g. other malignancy or severe heart disease
  • Transformation to plasma cell leukemia or aggressive lymphoma
  • Frequent visits for bortezomib injections not feasible
  • Anticipated non-adherence to study protocol
  • Pregnancy
  • Anticipated non-adherence to rules for prevention of pregnancy
  • Severe thrombocytopenia (Thrombocyte count less than 25000/microliter)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Norway,   Sweden
 
NCT00602511
NMSG 17/07, EudraCT no. 2007-001292-11
No
Martin Hjorth, Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden
Nordic Myeloma Study Group
Not Provided
Principal Investigator: Martin Hjorth, MD, PhD Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden
Nordic Myeloma Study Group
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP