Evaluation of the safety and efficacy of bortezomib combined with cyclophosphamide and dexamethasone for induction and maintenance therapy.
ID
Source
Brief title
Condition
- Haematological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Toxicity and efficacy of the combination of Bortezomib, Cyclofosfamide and
Dexametason during induction and maintenance therapy.
Secondary outcome
Survival
Background summary
To improve the treatment efficacy in patients with a relapse MM.
Study objective
Evaluation of the safety and efficacy of bortezomib combined with
cyclophosphamide and dexamethasone for induction and maintenance therapy.
Study design
Prospective multi-centre study.
Intervention
- Tripple therapy with Cyclofosfamide, Dexametason and Bortezomib during
induction phase.
- Cyclofosfamide and Bortezomib during maintenance therapy.
Study burden and risks
- Increased bone marrow toxicity.
- i.v.or s.c. injection of Bortezomib during maintenance therapy.
Hanzeplein 1
9713 GZ Groningen
NL
Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-004822-17-NL |
| CCMO | NL24138.042.08 |