EFFICACY AND SAFETY OF THE COMBINATION OF BORTEZOMIB, LENALIDOMIDE AND DEXAMETHASONE IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS
Phase 1
- Conditions
- Multiple myelomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002626-67-ES
- Lead Sponsor
- Institut Català d'Oncologia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 360
Inclusion Criteria
Informed consent form.
Untreated multiple myeloma.
IMWG criteria to start treatment
No major contraindication to treatment trial drugs.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240
Exclusion Criteria
Active concurrent disease precluding treatment.
Prior treatment for multiple myeloma.
Hypersensibility to bortezomib, lenalidomide or treatment excipients.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: Safety of the combination of bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma.<br><br> Proportion of patients completing 8 treatment cycles without dose reductions or drug discontinuations.<br> ;<br> Secondary Objective: Efficacy: CR rate at 3, 6 and 8 treatment cycles, progression-free survival and overall survival.<br><br> Safety by age group(<65 vs >65 years) and related to the addition of high-dose melphalan.<br> ;Primary end point(s): Proportion of patients completing 8 treatment cycles without requiring dose reductions or discontinuations.;Timepoint(s) of evaluation of this end point: End of study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Time to first bortezomib dose reduction, time to first lenalidomide dose reduction, overall and complete remission rate, progression-free survival and overall survival;Timepoint(s) of evaluation of this end point: End of study