Phase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in elderly patients in 1st relapse or primary refractory after first line therapy for multiple myeloma.
- Conditions
- multiple myeloma10035227Kahlers disease
- Registration Number
- NL-OMON33820
- Lead Sponsor
- HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 68
-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
-Not a candidate for high-dose therapy
-Measurable disease, i.e., serum M-compenent (>10 g/l), or urinary light-chain excretion (>200mg/24h), or abnormal free light chain (FLC) ratio with involved FLC > 100 mg/l or proven plasmacytoma by biopsy
-Able and/or willing to use adequate contraceptives (especially male patients)
-Written informed consent
-Prior therapy with Bortezomib or Lenalidomide
-History of allergic reaction 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 II or IV heart failure
-Myocardial infarction within the last 6 months of study entry
-Reduced left ventricular function with an ejection fraction *50% as measured
by MUGA scan or echocardiogram (another method for measuring cardiac function
is acceptable)
-Unstable angina
-Unstable cardiac arrhytmias
-Clinically significant pericardial disease
-Impaired hepatic or renal function
-ALT and/or AST > 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
-History of active malignancy in past 5 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phase I:<br /><br>-Dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended<br /><br>phase II dose (RDL) of Bortezomib and of Lenalidomide when combined with<br /><br>Dexamethasone<br /><br><br /><br>Phase II:<br /><br>-stringent complete response (sCR), CR and very good partial response (VGPR)<br /><br>rate</p><br>
- Secondary Outcome Measures
Name Time Method <p>Phase I:<br /><br>-Toxicity, especially myelosupression, polyneuropathy and thrombosis<br /><br><br /><br>Phase II:<br /><br>-Overall response<br /><br>-Improvement of response due to maintenance treatment<br /><br>-Toxicity, especially myelosupression, polyneuropathy and thrombosis<br /><br>-Progression free survival (calculated from registration and from start of<br /><br>maintenance treatment)<br /><br>-Overall survival (calculated from registration and from start of maintenance<br /><br>treatment)</p><br>