An Open-Label Phase I Study of the Safety of Perifosine in Combination With Lenalidomide and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma
Trial Information
An Open-Label Phase I Study of the Safety of Perifosine in Combination With Lenalidomide and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma
This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for
patients with relapsed or refractory multiple myeloma. All patients will receive
lenalidomide daily for days 1 to 21 of each 28 day cycle. Perifosine will be given daily
qhs with food. Dexamethasone will be given on days 1-4, 9-12 and 17-20 for 4 cycles. After
4 cycles dexamethasone will be given only on days 1-4. Four dose levels will be studied:
1. Perifosine 50 mg, lenalidomide 15 mg and dexamethasone 20 mg
2. Perifosine 50 mg, lenalidomide 25 mg and dexamethasone 20 mg
3. Perifosine 100 mg, lenalidomide 15 mg and dexamethasone 20 mg
4. Perifosine 100 mg, lenalidomide 25 mg and dexamethasone 20 mg
Six patients will be enrolled at each dose level until the maximum tolerated dose (MTD) is
reached. Six additional patients will be treated at the MTD.
Inclusion Criteria:
- Subject was previously diagnosed with multiple myeloma based on standard diagnostic
criteria, as follows.
- Major criteria:
1. Plasmacytomas on tissue biopsy.
2. Bone marrow plasmacytosis (> 30% plasma cells).
3. Monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin G (IgG)
>3.5 g/dL or immunoglobulin A (IgA) > 2.0 g/dL; kappa or lambda light chain
excretion > 1 g/day on 24 hour urine protein electrophoresis.
- Patients must have relapsed or refractory disease (refractory is defined as
progression during treatment or within 60 days after the completion of treatment)
requiring 2nd or 3rd line therapy
- Patients refractory to a combination of lenalidomide and dexamethasone will not be
eligible. Patients may have received lenalidomide and/or dexamethasone
Exclusion Criteria:
- Renal insufficiency (serum creatinine levels > 3 mg/dL)..
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to perifosine (miltefosine or edelfosine).
- Known hypersensitivity to thalidomide
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Adverse Events
Outcome Time Frame:
Every cycle
Safety Issue:
Yes
Principal Investigator
Andrzej J Jakubowiak, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Michigan
Authority:
United States: Food and Drug Administration
Study ID:
Perifosine 127
NCT ID:
NCT00415064
Start Date:
December 2006
Completion Date:
July 2012
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Perifosine
- Lenalidomide
- Dexamethasone
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Flint, Michigan 48532 |
