EFFICACY AND SAFETY OF THE COMBINATION OF BORTEZOMIB, LENALIDOMIDE AND DEXAMETHASONE IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS

EFFICACY AND SAFETY OF THE COMBINATION OF BORTEZOMIB, LENALIDOMIDE AND DEXAMETHASONE IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS - Safety and efficacy of bortezomib, lenalidomide and dexamethasone in multiple myeloma

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002626-67-ES

Enrollment

360

Registered

2019-11-11

Start date

2020-01-09

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma

Interventions

Trade Name: Velcade Product Name: bortezomib Pharmaceutical Form: Powder and solution for solution for injection Trade Name: Revlimid P

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Active concurrent disease precluding treatment. Prior treatment for multiple myeloma. Hypersensibility to bortezomib, lenalidomide or treatment excipients.

Design outcomes

Primary

Measure	Time frame
Main Objective: Safety of the combination of bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma. Proportion of patients completing 8 treatment cycles without dose reductions or drug discontinuations. ; Secondary Objective: Efficacy: CR rate at 3, 6 and 8 treatment cycles, progression-free survival and overall survival. Safety by age group(65 years) and related to the addition of high-dose melphalan. ;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	—

Measure

Time frame

Main Objective: Safety of the combination of bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma. Proportion of patients completing 8 treatment cycles without dose reductions or drug discontinuations. ; Secondary Objective: Efficacy: CR rate at 3, 6 and 8 treatment cycles, progression-free survival and overall survival. Safety by age group(65 years) and related to the addition of high-dose melphalan. ;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

Measure	Time frame
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	—

Countries

Spain

Contacts

Public ContactUIC - ICO Badalona

Institut Català d'Oncologia

aoriol@iconcologia.net

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026