Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Bortezomib Drug: Thalidomide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma |
- Progression free survival [ Time Frame: Not specified ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Bortezomib - dexamethasone
|
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 |
|
Experimental: 2
Thalidomide - dexamethasone
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00602511
| Denmark | |
| Ålborg university Hospital | |
| Aalborg, Denmark, 9000 | |
| Herlev University Hospital | |
| Herlev, Denmark, 2730 | |
| Rigshospitalet | |
| Koebenhavn, Denmark, 2100 | |
| Odense University Hospital | |
| Odense, Denmark, 5000 | |
| Århus University Hospital | |
| Århus, Denmark, 8000 | |
| Norway | |
| Ullevål Sykehus | |
| Oslo, Norway, 0407 | |
| Diakonhjemmet | |
| Oslo, Norway | |
| Stavanger Universitetssykehus | |
| Stavanger, Norway, 4068 | |
| Trondheim University Hospital | |
| Trondheim, Norway, N-7006 | |
| Sweden | |
| Falun Hospital | |
| Falun, Sweden, 79182 | |
| Gävle Hospital | |
| Gävle, Sweden, 80187 | |
| Sahlgrenska University Hospital | |
| Göteborg, Sweden, 41345 | |
| Helsingborg Hospital | |
| Helsingborg, Sweden, 25187 | |
| Lidköping Hospital | |
| Lidköping, Sweden, 53185 | |
| Lund University Hospital | |
| Lund, Sweden, 22185 | |
| Malmö University Hospital | |
| Malmö, Sweden, 20502 | |
| Mölndal hospital | |
| Mölndal, Sweden, 43180 | |
| Skövde Hospital | |
| Skövde, Sweden, 54185 | |
| St Göran Hospital | |
| Stockholm, Sweden, 11281 | |
| Sundsvall Hospital | |
| Sundsvall, Sweden, 85186 | |
| Uddevalla Hospital | |
| Uddevalla, Sweden, 45180 | |
| Norrland University Hospital | |
| Umeå, Sweden, 90185 | |
| Uppsala University Hospital | |
| Uppsala, Sweden, 75185 | |
| Västerås Hospital | |
| Västerås, Sweden, 72189 | |
| Växjö Hospital | |
| Växjö, Sweden, 35185 | |
| Örebro University Hospital | |
| Örebro, Sweden, 70185 | |
| Örnsköldsvik Hospital | |
| Örnsköldsvik, Sweden, 89189 | |
| Principal Investigator: | Martin Hjorth, MD, PhD | Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden |
More Information
| Responsible Party: | Martin Hjorth, Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden |
| ClinicalTrials.gov Identifier: | NCT00602511 History of Changes |
| Other Study ID Numbers: | NMSG 17/07 EudraCT no. 2007-001292-11 |
| Study First Received: | January 15, 2008 |
| Last Updated: | February 8, 2011 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Nordic Myeloma Study Group:
|
Melfalan refractory multiple myeloma Multiple myeloma Relapsing Refractory |
Thalidomide Bortezomib Randomized clinical trial |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Bortezomib Melphalan Thalidomide BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on September 28, 2016