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 - originally also known as Velcade IIS
- 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-AT
- Lead Sponsor
- European Group for Blood and Marrow Transplantation (EBMT)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 452
•Male or female and at least 18 years of age
•Histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters
•Relapsing of having a progressive disease after an autologous transplantation
•Relapse as defined by the following:
1.reappearance of serum or urinary paraprotein in immunofixation or routine electrophoresis, confirmed by at least one further investigation and excluding oligoclonal immune reconstitution.
2.>5% plasma cells in a bone marrow aspirate or on trephine bone biopsy
3.development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions. Development of a compression fracture does not exclude response
4.development of hypercalcemia, corrected serum calcium >11.5mg/dL or 2.8 mmol/L, that is not attributable to any other cause
•progressive disease as defined by one of the following:
1)>25% increase in the level of the serum monoclonal paraprotein (5g/l increase minimum and at least 2 investigations)
2)>25% increase in the 24h urinary light chain excretion (200 mg/d increase minimum and at least 2 investigations)
3)>25% increase in plasma cells in a bone marrow aspirate (absolute increase of at least 10%)
4)Increase in the size of the existing bone lesions or soft tissue plasmacytomas
5)New bone lesions or soft tissue plasmacytomas
6)Onset of hypercalcemia not attributable to any other cause.
•Measurable disease defined as: quantifiable serum monoclonal antibody defined as a serum monoclonal protein >1g/dL for IgG, or >0.5g/dL for IgA
•Karnofsky performance status >50%
•Life expectancy of at least 3 months
•Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the duration of the study
•Negative serum or urine -HCG pregnancy test at screening for subjects for child bearing potential
•Voluntary written consent before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
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
·Patients with Non-secretory Multiple myeloma
· Karnofsky performance status < or equal to 50%
·Patient has a platelet count < 40,000 X 109/L within 14 days before enrollment
·Patient has an absolute neutrophil count <1.0 X 109/L within 14 days before enrollment
·Creatinine clearance <30 mL/minute within 14 days before enrollment
·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 received 14 days before enrollment
·Serious medical or psychiatric illness
·Previous or concurrent malignancies at other sites, with the exception of appropriately treated localized epithelial skin or cervical cancer. Patient with remote histories (>5 years) of other cured tumors may be entered
·Poorly controlled hypertension, uncontrolled or severe cardiovascular
disease or uncontrolled diabetes mellitus
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method