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NCT Number: NCT00602511

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes 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 Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ålborg university Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

bortezomib

Drug

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

thalidomide

Drug

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

Primary outcomes

  1. Progression free survival

Secondary outcomes

  1. Response rate

  2. Response duration

  3. Time to start of other treatment

  4. Toxicity

  5. Quality of life

  6. Response rate after cross-over

  7. Response duration after cross-over

Sponsors and collaborators

Lead sponsor

Nordic Myeloma Study Group

Other

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 28, 2008
Registry last updated
Feb 9, 2011

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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