BENDAMUSTINE, DEXAMETHASONE AND THALIDOMIDE IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA PATIENTS.

PHASE II MULTICENTER CLINICAL TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF BENDAMUSTINE, DEXAMETHASONE AND THALIDOMIDE IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA PATIENTS AFTER TREATMENT WITH LENALIDOMIDE AND BORTEZOMIB OR WHICH ARE INELIGIBLE TO ONE OF THESE DRUGS.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001775-39-IT

Enrollment

Registered

2012-03-14

Start date

2011-09-20

Completion date

Unknown

Last updated

2018-02-19

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

Conditions

Relapsed or refractory active MM (according to the International Myeloma Working Group guidelines) after treatments containing bortezomib and lenalidomide or ineligible (intolerance or toxicity) to one of these drugs with detectable myeloma protein in blood or urine. MedDRA version: 14.1 Level: PT Classification code 10051381 Term: Myeloma recurrence System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Ribomustin Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE CAS Number: 3543757 Current Sponsor code: NA Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Relapsed or refractory active MM after treatments containing bortezomib and lenalidomide or ineligible to one of these drugs. • Age 18 years. • All previous multiple myeloma treatments, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, except corticosteroids therapy. • ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • Patients with contraindications for treatment with bendamustine, dexamethasone and thalidomide. • Uncontrolled or severe cardiovascular disease. • Known hypersensitivity to thalidomide or purine analogues • Concurrent use of other anti-cancer agents or treatments other stated in this treatment plan. • Peripheral neuropathy grade =2 according to WHO • Known positive for HIV or infectious hepatitis, type A, B or C. • Pregnant or breast feeding females.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of BDT in relapsed or refractory multiple myeloma as measured by the rate of responses (time frame 18 months).;Secondary Objective: To assess: - tolerability and toxicity - Time to treatment failure and overall survival - Disease free survival;Primary end point(s): Efficacy as measured by the rate of responses;Timepoint(s) of evaluation of this end point: Within 18 months.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of BDT in relapsed or refractory multiple myeloma as measured by the rate of responses (time frame 18 months).;Secondary Objective: To assess: - tolerability and toxicity - Time to treatment failure and overall survival - Disease free survival;Primary end point(s): Efficacy as measured by the rate of responses;Timepoint(s) of evaluation of this end point: Within 18 months.

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Secondary

Measure	Time frame
Secondary end point(s): Time to treatment failure, overall survival and disease free survival at 18 months.;Timepoint(s) of evaluation of this end point: 18 months.	—

Countries

Italy

Contacts

Public ContactDIVISIONE DI EMATOLOGIA E TMO

AZIENDA OSPEDALIERA DI BOLZANO

michael.mian@asbz.it0471908807

Outcome results

None listed

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