Multiple Myeloma Clinical Trial
Official title:
A Phase I/II Study of Oral Melphalan Combined With LBH589 for Patients With Relapsed or Refractory Multiple Myeloma (MM)
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from dividing.
Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for
cell growth. Giving melphalan together with panobinostat may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan when
given together with panobinostat in treating patients with recurrent multiple myeloma.
OBJECTIVES:
Primary
- To establish the maximum tolerated dose (MTD) and determine the dose-limiting
toxicities (DLT) of panobinostat in combination with melphalan in patients with
relapsed or refractory multiple myeloma. (Phase I)
- To determine the dose of this regimen to be used in the Phase II portion of the study.
(Phase I)
- To determine the efficacy as evidenced by the response rate (combined complete
response, very good partial response, partial response, and minimal response) in
patients treated with this regimen. (Phase II)
Secondary
- To obtain preliminary evidence of efficacy of the combination of LBH589 and melphalan
for patients with relapsed or refractory multiple myeloma. (Phase I)
- To determine the safety and tolerability of this regimen in these patients. (Phase II)
- To determine time to disease progression, time to response, and duration of response in
patients treated with this regimen. (Phase II)
- To determine progression-free survival and overall survival of patients treated with
this regimen. (Phase II)
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II study.
Patients receive oral panobinostat once daily on days 1, 3, 5, 8, 10, and 12 and oral
melphalan once daily on days 1, 3 and 5. Treatment repeats every 28 days for up to 8 courses
in the absence of disease progression or unacceptable toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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