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Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

Phase 3
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

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.

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)

Type of Study:


Study Design:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

Not specified

Safety Issue:


Principal Investigator

Martin Hjorth, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden


Sweden: Medical Products Agency

Study ID:

NMSG 17/07



Start Date:

October 2007

Completion Date:

December 2010

Related Keywords:

  • Multiple Myeloma
  • Melfalan refractory multiple myeloma
  • Multiple myeloma
  • Relapsing
  • Refractory
  • Thalidomide
  • Bortezomib
  • Randomized clinical trial
  • Multiple Myeloma
  • Neoplasms, Plasma Cell