multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: Revlimid
Pharmaceutical Form: Capsule, hard
Trade Name: Velcade
Pharmaceutical Form: Powder for injection*
Product Name: dexamethasone
Pharmaceutical Form: Capsule*
INN or Proposed INN:
Sponsors
HOVON Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Multiple Myeloma Salmon/Durie stage II/III A+B - Primary refractory to or first relapse after previous objective response (PR, VGPR, CR) on standard first-line treatment - Age 60 – 85 years inclusive - Not a candidate for high-dose therapy -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 - Able and/or willing to use adequate contraceptives (especially male patients) - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Prior therapy with Bortezomib or Lenalidomide -History of allergic reaction attributable to compounds containing boron or mannitol. -Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3. -AL amyloidosis - Uncontrolled or severe cardiovascular disease: New York Heart Association (NYHA) Class III or IV heart failure Myocardial infarction within the last 6 months of study entry Reduced left ventricular function with an ejection fraction 3 x normal value Bilirubin > 3 x normal value Serum creatinin > 3 x normal value (after adequate hydration) - Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.) - Known HIV positivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1 To determine the maximum tolerated dose (MTD) and recommended phase II dose level (RDL) of Bortezomib administered once weekly, and of Lenalidomide administered for 3 weeks when combined with Dexamethasone in a 28-days schedule. Phase 2 To investigate the efficacy of a maximum of 8 cycles of Bortezomib plus Lenalidomide with Dexamethasone at the RDL, as determined by the (s)CR+VGPR rate;Secondary Objective: Phase I To evaluate toxicity, especially myelosuppression, polyneuropathy and thrombosis Phase II - To evaluate the effect of maintenance treatment with Lenalidomide in patients who have achieved any response (sCR, CR, VGPR, or PR) upon treatment with the combination of Bortezomib plus Lenalidomide with Dexamethasone - To evaluate toxicity, especially myelosuppression, polyneuropathy and thrombosis - To evaluate progression free survival - To evaluate overall survival ;Primary end point(s): Phase I - 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 - (s)CR+VGPR rate. | — |
Countries
Belgium, Netherlands
Outcome results
None listed