A Randomized controlled study of Velcade (Bortezomib) plus Thalidomide plus Dexamethasone compared to Thalidomide plus Dexamethasone for the treatment of myeloma patients progressing or relapsing after autologous transplantation (MMVAR). - MMVAR

Phase 1

• Conditions: Male or female subjects, 18 years-of-age or older, with multiple myeloma who received at least one autologous transplantation and who have responded and later progressed or relapsed at least one year after transplantation

• Registration Number: EUCTR2005-001628-35-GB
• Lead Sponsor: European Group for Blood and Marrow Transplantation (EBMT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 452

Inclusion Criteria

·Male or female =18 years-of-age
·Multiple myeloma with evaluable disease
·Relapsing or having a progressive disease at least one year after an
autologous transplantation
·Karnofsky performance status > 50 %
·Life expectancy of at least 3 months
·Female of child-bearing potential must have a method of birth control
and a negative serum or urine ß-HCG pregnancy test at screening and
all through the study
·Male must use contraception
·Voluntary written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Non-secretory Multiple myeloma
·Platelet count < 40,000 X 109/L
·Absolute neutrophil count <1.0 X 109/L
·Creatinine clearance <30 mL/minute
·Peripheral neuropaty >= Grade 2
·Seropositive for HIV, or active hepatitis A, B or C infection
·Pregnant or breastfeeding female
·Patient has hypersensitivity to bortezomib, boron or mannitol
·Other investigational drugs
·Serious medical or psychiatric illness
·Previous or concurrent malignancies at other sites
·Poorly controlled hypertension, uncontrolled or severe cardiovascular
disease or uncontrolled diabetes mellitus
•Concurrent cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, in particular pericarditis, or cardiac amyloidosis.
•Concurrent significant pulmonary disease, in particular interstitial pneumonia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified