Pomalidomide combined with Carfilzomib and Dexamethasone (PCd) forinduction and consolidation followed by Pomalidomide combined withDexamethason vs Pomalidomide maintenance for patients with MultipleMyeloma in progression after prior 1st line treatment with Lenalidomideand Bortezomib.
Recruiting
- Conditions
- Multiple MyelomaMultiple Myeloomziekte van Kahler
- Registration Number
- NL-OMON24039
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 222
Inclusion Criteria
Included in EMN02/HO95 trial
- The subject must understand and voluntarily sign an informed consent
document prior to any study related assessments/procedures.
Exclusion Criteria
- Absolute neutrophil count (ANC) <1.0 x 109/L, unless related to MM.
- Platelet count < 75 x 109/L, unless related to MM.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Progression free survival (PFS) from randomization, defined as time<br>from randomization to progression or death from any cause which ever<br>occur first. Patient still alive at the date of last contact will be censored.<br /><br>- Response rate (sCR, CR, VGPR, PR) after induction and consolidation<br>treatment
- Secondary Outcome Measures
Name Time Method -Response rate after 8 cycles of PCD before start of maintenance<br /><br>-Toxicity<br /><br>-Improvement of response during/after maintenance<br /><br>-Progression free survival calculated registration<br /><br>-Overall survival calculated from time of registration or from start of<br>maintenance treatment, until death from any cause. Patients still alive at<br>the date of last contact will be censored.<br /><br>-Quality of life as defined by the EORTC QLQ-C30 and QlQ-MY20.