Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

Phase 3

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Thalidomide; Drug: Bortezomib

• Registration Number: NCT00602511
• Lead Sponsor: Nordic Myeloma Study Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-28
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-08
• Last Update Posted: 2011-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Thalidomide	Thalidomide - dexamethasone
1	Bortezomib	Bortezomib - dexamethasone

Primary Outcome Measures

Name	Time	Method
Progression free survival

Secondary Outcome Measures

Name	Time	Method
Response rate
Response duration
Time to start of other treatment
Toxicity
Quality of life
Response rate after cross-over
Response duration after cross-over

Trial Locations

Locations (27)

Trondheim University Hospital; 🇳🇴 Trondheim, Norway

Herlev University Hospital; 🇩🇰 Herlev, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Århus University Hospital; 🇩🇰 Århus, Denmark

Lidköping Hospital; 🇸🇪 Lidköping, Sweden

Skövde Hospital; 🇸🇪 Skövde, Sweden

Norrland University Hospital; 🇸🇪 Umeå, Sweden

Ålborg university Hospital; 🇩🇰 Aalborg, Denmark

Diakonhjemmet; 🇳🇴 Oslo, Norway

Malmö University Hospital; 🇸🇪 Malmö, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

Stavanger Universitetssykehus; 🇳🇴 Stavanger, Norway

Helsingborg Hospital; 🇸🇪 Helsingborg, Sweden

Sundsvall Hospital; 🇸🇪 Sundsvall, Sweden

Uddevalla Hospital; 🇸🇪 Uddevalla, Sweden

Växjö Hospital; 🇸🇪 Växjö, Sweden

Rigshospitalet; 🇩🇰 Koebenhavn, Denmark

Falun Hospital; 🇸🇪 Falun, Sweden

Ullevål Sykehus; 🇳🇴 Oslo, Norway

Gävle Hospital; 🇸🇪 Gävle, Sweden

Lund University Hospital; 🇸🇪 Lund, Sweden

Mölndal hospital; 🇸🇪 Mölndal, Sweden

Västerås Hospital; 🇸🇪 Västerås, Sweden

Örebro University Hospital; 🇸🇪 Örebro, Sweden

Örnsköldsvik Hospital; 🇸🇪 Örnsköldsvik, Sweden

St Göran Hospital; 🇸🇪 Stockholm, Sweden