multipel myeloma plasma cell disease
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria * Patients with relapsed or progressive multiple myeloma who did not receive treatment with bortezomib before, and requiring treatment * At least one manifest osteolytic lesion * Age 18-75 * Not on active treatment with dexamethasone in the last 4 weeks, or requiring immediate treatment with dexamethasone * Patients on bisphosphonate treatment are allowed if bisphosphonates were started * 3 months before registration * WHO performance 0-2 (Appendix A)
Exclusion criteria
Exclusion criteria: * Polyneuropathy * grade 2 * Severe cardiac dysfunction (NYHA classification II-IV, appendix B) * Severe pulmonary dysfunction * Significant hepatic dysfunction (total bilirubin * 30 umol/l or transaminases * 3 times normal level), unless related to myeloma * Creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint - Accurateness of the [18F]PET/CT scans to depict bone turnover in vivo and on site - Bone turnover before and after completion of bortezomib treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints - Bone turnover in patients with a documented anti-MM response on bortezomib versus patients without a response on bortezomib (according to the response criteria in appendix C). Separate analysis for the qualitiy of response will be performed. | — |
Countries
Netherlands
Outcome results
None listed