Multiple myeloma Cancer Multiple myeloma
Conditions
Interventions
Arm A: Bendamustine (60), thalidomide, dexamethasone -
Bendamustine: Intravenous at 60 mg/m2/day on days 1 and 2 (30 - 60 minute infusion each day)
Thalidomide: Oral at
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 13/08/2012: 1. Aged greater than or equal to 18 years, either sex 2. Histologically confirmed multiple myeloma (MM) with measurable disease parameters requiring therapy for relapsed or refractory disease 3. Unsupported platelet count >75 x 109/L within 48 hours before registration 4. Absolute neutrophil count >1.5 x 109/L within 48 hours before registration. GCSF is permitted for no more than 7 days prior to registration. 5. Able to provide written informed consent 6. Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 - 3 7. Life expectancy at least 3 months Previous inclusion criteria until 13/08/2012: 1. Aged greater than or equal to 18 years, either sex 2. Histologically confirmed multiple myeloma (MM) with measurable disease parameters requiring therapy for relapsed or refractory disease 3. Able to provide written informed consent 4. Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 - 3 5. Life expectancy at least 3 months 6. Serum bilirubin less than 1.5 times upper limit of normal 7. Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than 2.5 times upper limit of normal
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 13/08/2012: 1. Pregnancy, lactation or women of child-bearing potential unwilling to use adequate and highly effective method of contraception whilst receiving treatment and for 12 months after treatment has finished as defined by the Thalidomide Pregnancy Prevention Programme 2. Patients with non-secretory MM 3. Relapsed on previous bendamustine therapy 4. Serum bilirubin >2.0 times ULN within 14 days before registration 5. Serum ALT/AST > 2.5 times ULN within 14 days before registration 6. Patient has a calculated or measured creatinine clearance less than 10 mL/minute within 14 days before enrolment 7. Patient has greater than or equal to grade 2 peripheral neuropathy within 14 days before enrolment 8. Any history of hypersensitivity to any of the study medications or excipients 9. Seropositive for human immunodeficiency virus (HIV), or active hepatitis A, B or C infection 10. Previous or concurrent malignancies at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer. Patients with histories (greater than or equivalent to 12 months) of other cured tumours may be entered. 11. Serious medical or psychiatric illness likely to interfere with participation in this clinical study 12. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 13. Subjects who have received an investigational medicinal product within 28 days of study entry 14. Steroid treatment totally greater than 160mg dexamethasone, or equivalent, in the 14 days prior to registration 15. Major surgery less than 30 days before start of treatment 16. Yellow fever vaccination within 3 months before registration 17. Current infections, especially involving leukocytopenia Previous exclusion criteria until 13/08/2012: 1. Pregnancy, lactation or women of child-bearing potential unwilling to use adequate and highly effective method of contraception whilst receiving treatment and for 12 months after treatment has finished as defined by the Thalidomide Pregnancy Prevention Programme 2. Subjects with evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, electrocardiogram (ECG) results, and physical examination that, in the Investigator's opinion, preclude entry into the study 3. Any history of hypersensitivity to any of the study medications or excipients 4. Patients with non-secretory MM 5. Patient has a platelet count less than 40 x 10^9/L within 14 days before enrolment 6. Patient has an absolute neutrophil count less than 1.0 x 10^9/L within 14 days before enrolment 7. Patient has a calculated or measured creatinine clearance less than 10 mL/minute within 14 days before enrolment 8. Patient has greater than or equal to grade 2 peripheral neuropathy within 14 days before enrolment 9. Seropositive for human immuno
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients achieving at least a partial response (as defined by the Modified International Working Group [IWG] Uniform Response Criteria) within six cycles of treatment, measured within 6 months of start of treatment, i.e., 18 months post-first patient 2. Proportion of patients successfully able to receive their second cycle of bendamustine within six weeks of receiving their first cycle, measured within 6 months of start of treatment, i.e., 18 months post-first patient 3. Progression-free survival, measured at 12 months post-randomisation, i.e., 24 months post first patient | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maximum response rate 2. Overall response rate 3. Response duration 4. Time to next treatment 5. Proportion of patients successfully receiving six cycles of treatment with no dose reductions or delays 6. Safety and toxicity 7. Feasibility of stem cell harvest following treatment (in eligible refractory patients) All measured within 12 months of randomisation, i.e., within 24 months post-first patient | — |
Countries
England, United Kingdom
Outcome results
None listed