The primary objective of this study is:To determine the response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.Secondary objectives…
ID
Source
Brief title
Condition
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary efficity parameters are the lab. results in comparison with the
baseline result.
Secondary outcome
Number of adverse events and side effects.
Background summary
Waldenstrom's macroglobulinemia (WM) is a distinct B-cell lymphoproliferative
disorder characterized primarily by bone marrow infiltration with
lymphoplasmacytic cells, along with demonstration of an IgM monoclonal
gammopathy
Despite continuing advances in the therapy of WM, the disease remains incurable
with a median survival of 5 to 8 years.
Study objective
The primary objective of this study is:
To determine the response rate [the combined complete response (CR) + partial
response (PR) + minimal response (MR)] following treatment with BDR in patients
with previously untreated WM.
Secondary objectives are:
To determine time to progression following treatment with BDR
To assess the safety and tolerability of BDR in patients with WM.
Study design
Screening, treatment and follow up fase. Treatment consists of 5 cycli of 35
days. Medications is given intravenously. Follow up visit outdoor patient
clinic every 3 months for 2 years after which visits every 6-12 months.
Intervention
n.a.
Study burden and risks
The side effect of medication used is known, however the side effects caused by
this combination of medicine are not known.
Centrumlocatie, 's Gravendijkwal 230
3015 CE Rotterdam
NL
Centrumlocatie, 's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Clinicopathological diagnosis of Waldenstrom*s macroglobulinemia as defined by consensus panel one of the Second International Workshop on Waldenstrom*s macroglobulinemia. All patients with the diagnosis of WM will be evaluable for response according to the response criteria.
No prior systemic treatment for WM. Prior plasmapheresis to control hyperviscosity, is allowed.
Exclusion criteria
Prior systemic treatment with WM (plasmapheresis is allowed)
Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
Patient has hypersensitivity to dexamethasone, bortezomib, boron or mannitol.
Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Cardiac amyloidosis.
Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI CTCAE version 3.
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 | EUCTR2006-003563-31-NL |
| CCMO | NL14911.078.06 |