BENDAMUSTINE, DEXAMETHASONE AND THALIDOMIDE INRELAPSED OR REFRACTORY MULTIPLE MYELOMA PATIENTS.

Phase 1

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 myelomaprotein in blood or urine.
Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 14.1Level: PTClassification code 10051381Term: Myeloma recurrenceSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2011-001775-39-IT

Lead Sponsor: AZIENDA SANITARIA DELL'ALTO ADIGE - COMPRENSORIO SANITARIO DI BOLZANO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

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 <2 at study entry, unless it is due to MM.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: <br>- tolerability and toxicity<br>- Time to treatment failure and overall survival<br>- 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.

Secondary Outcome Measures

Name	Time	Method
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.