LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia (NCT00936611) | Clinical Trial Compass
CompletedPhase 2
LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia
United States39 participantsStarted 2009-07
Plain-language summary
The purpose of this research study is to assess the overall response rate of LBH589 in patients with relapsed or refractory Waldenstrom's Macroglobulinemia. LBH589 is a newly discovered compound that has killed Waldenstrom cells in laboratory studies, however, it is not known if LBH589 will show the same activity in people with Waldenstrom's Macroglobulinemia. This drug has been used in research for the treatment of other types of cancer, such as multiple myeloma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female patients aged 18 years or older
* Must have received prior therapy for their WM, any number of prior therapies is allowed
* Must have symptomatic relapsed or refractory WM
* Measurable monoclonal IgM protein in the blood and presence of lymphoplasmacytic cells in the bone marrow during any previous bone marrow
* Laboratory values as described in the protocol
* Clinically euthyroid
* ECOG Performance Status of 2 or less
Exclusion Criteria:
* Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
* Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 treatment
* Peripheral neuropathy CTCAE grade 2 or higher
* Impaired cardiac function or clinically significant cardiac diseases
* Impairment of GI function or GI disease that may significantly alter the absorption of LBH589
* Diarrhea \> CTCAE grade 1
* Other concurrent severe and/or uncontrolled medical conditions including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
* Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
* Patients who have received targeted agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is longer) and who have …
What they're measuring
1
Overall Response Rate
Timeframe: Assessed after 2nd cycle and then every subsequent cycle for 6 cycles. The median number of completed cycles of therapy was 5 (0- 32). As such observed up to ~32 months.