Bortezomib in combination with continuous low-dose oral cyclophosphamide and dexamethason followed by maintenance in primary refractory or relapsed bortezomib naïve multiple myeloma patients
- Conditions
- Evaluation of the safety and efficacy of bortezomib combined with cyclophosphamide and dexametasone for induction and maintenance in bortezomib naive refractory on relapsed MM, stage II - III.
- Registration Number
- EUCTR2008-004822-17-NL
- Lead Sponsor
- niversity Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Age = 18 years
Stage II-III Multiple Myeloma
Relapse or primary refractory disease after initial chemotherapy
WHO performance status 0 – 2
Life expectancy of at least 6 weeks
ANC (absolute neutrophil count) = 1.0x109/l
(or = 0.5x109/l, if due to bone marrow infiltration by malignancy)
Platelet count = 75x109/l
(or = 50x109/l, if due to bone marrow infiltration by malignancy)
Written informed consent (present in patient’s file)
Patient is able and willing to use adequate contraception during therapy and for at
least 1 month after study
Patient has the ability to understand the requirements of the study
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
Previous treatment with bortezomib
Urine production < 1.5 l/24h
Pre-existent polyneuropathy (grade 2 or higher, according to CTCAE 3.0)
Pregnancy or positive pregnancy tests during study and for 1 month after final dose of thalidomide
History of active malignancy during the past 5 years
(with the exception of basal carcinoma of the skin)
Active uncontrolled infections
Additional uncontrolled serious medical or psychiatric illness
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