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
- Multiple myeloma10018849M. Kahler.
- Registration Number
- NL-OMON38293
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 73
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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Toxicity and efficacy of the combination of Bortezomib, Cyclofosfamide and<br /><br>Dexametason during induction and maintenance therapy.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Survival</p><br>