Multiple Myeloma, 1st relapse or refractory after first line therapy
Conditions
Interventions
During the phase I part of the study, the MTD and RDL of Bortezomib and Lenalidomide with Dexamethasone will be determined according to a slightly modified `3 + 3’ dose-escalation scheme, as illustrat
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 7041560
Fax: 010 7041028
Eligibility
Inclusion criteria
Inclusion criteria: 1. Multiple Myeloma Salmon/Durie stage II/III A+B 2. Primary refractory to or first relapse after previous objective response (PR, VGPR, CR) on standard first-line treatment 3. Age 60 – 85 years inclusive 4. Not a candidate for high-dose therapy 5. Measurable disease, i.e., serum M-component (>10 g/l), or urinary light-chain excretion (>200mg/24h),or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/l or proven plasmacytoma by biopsy 6. Able and/or willing to use adequate contraceptives (especially male patients) 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Prior therapy with Bortezomib or Lenalidomide 2. History of allergic reaction attributable to compounds containing boron or mannitol 3. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 4. AL amyloidosis 5. Uncontrolled or severe cardiovascular disease 6. Impaired hepatic or renal function 7. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.) 8. Known HIV positivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I Primary endpoint - Dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II dose (RDL) of Bortezomib and of Lenalidomide when combined with Dexamethasone. Phase II Primary endpoint - (s)CR+VGPR rate. In order for patients to be considered as a success for the primary endpoint, a VGPR or (s)CR must be documented according to criteria in appendix B. All other patients will be considered as not having achieved at least a VGPR. In this analysis we will consider the best response obtained during induction/consolidation chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I Secondary endpoint - Toxicity, especially myelosuppression, polyneuropathy and thrombosis Phase II Secondary endpoints - Overall Response - Improvement of response due to maintenance treatment - Toxicity, especially myelosuppression, polyneuropathy and thrombosis - Progression free survival (PFS; i.e. time from registration to progression or death from any cause, whichever comes first) - Overall survival measured from registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive - PFS calculated from start of maintenance treatment - OS calculated from start of maintenance treatment | — |
Contacts
Public ContactP. Sonneveld
P.O. Box 2040
Outcome results
None listed