Phase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in patients in 1st relapse or primary refractory after first line therapy for Multiple Myeloma.
Recruiting
- Conditions
- Multiple Myeloma, 1st relapse or refractory after first line therapy
- Registration Number
- NL-OMON23532
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 7041560Fax: 010 7041028
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 72
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
Exclusion Criteria
1. Prior therapy with Bortezomib or Lenalidomide
2. History of allergic reaction attributable to compounds containing boron or mannitol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I Primary endpoint<br /><br>- Dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II dose (RDL) of Bortezomib and of Lenalidomide when combined with Dexamethasone. <br><br /><br /><br>Phase II Primary endpoint<br /><br>- (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 Outcome Measures
Name Time Method Phase I Secondary endpoint<br><br /><br>- Toxicity, especially myelosuppression, polyneuropathy and thrombosis<br><br /><br /><br>Phase II Secondary endpoints<br /><br>- Overall Response<br /><br>- Improvement of response due to maintenance treatment<br /><br>- Toxicity, especially myelosuppression, polyneuropathy and thrombosis<br /><br>- Progression free survival (PFS; i.e. time from registration to progression or death from any cause, whichever comes first)<br /><br>- 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<br /><br>- PFS calculated from start of maintenance treatment<br /><br>- OS calculated from start of maintenance treatment<br /><br>