Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

Multiple Myeloma Clinical Trial

Official title:

Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602511
• Other study ID #: NMSG 17/07
• Secondary ID: EudraCT no. 2007
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2008
• Last updated: February 8, 2011
• Start date: October 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: Nordic Myeloma Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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
• 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

Locations

Country	Name	City	State
Denmark	Ålborg university Hospital	Aalborg
Denmark	Århus University Hospital	Århus
Denmark	Herlev University Hospital	Herlev
Denmark	Rigshospitalet	Koebenhavn
Denmark	Odense University Hospital	Odense
Norway	Diakonhjemmet	Oslo
Norway	Ullevål Sykehus	Oslo
Norway	Stavanger Universitetssykehus	Stavanger
Norway	Trondheim University Hospital	Trondheim
Sweden	Falun Hospital	Falun
Sweden	Gävle Hospital	Gävle
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Helsingborg Hospital	Helsingborg
Sweden	Lidköping Hospital	Lidköping
Sweden	Lund University Hospital	Lund
Sweden	Malmö University Hospital	Malmö
Sweden	Mölndal hospital	Mölndal
Sweden	Örebro University Hospital	Örebro
Sweden	Örnsköldsvik Hospital	Örnsköldsvik
Sweden	Skövde Hospital	Skövde
Sweden	St Göran Hospital	Stockholm
Sweden	Sundsvall Hospital	Sundsvall
Sweden	Uddevalla Hospital	Uddevalla
Sweden	Norrland University Hospital	Umeå
Sweden	Uppsala University Hospital	Uppsala
Sweden	Västerås Hospital	Västerås
Sweden	Växjö Hospital	Växjö

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Myeloma Study Group

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		Not specified	No
Secondary	Response rate		Not specified	No
Secondary	Response duration		Not specified	No
Secondary	Time to start of other treatment		Not specified	No
Secondary	Toxicity		Not specified	Yes
Secondary	Quality of life		Not specified	No
Secondary	Response rate after cross-over		Not specified	No
Secondary	Response duration after cross-over		Not specified	No