Overview

Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma

Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
Summary
This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. The current protocol will enroll patients with relapsed or refractory multiple myeloma requiring second or third line therapy. Six patients each will be treated with at one of 4 dose levels in a phase 1 study. All patients will receive perifosine, lenalidomide and dexamethasone of each 28 day cycle. The doses of perifosine and lenalidomide will be varied in each group. The dose of dexamethasone will remain constant.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AEterna Zentaris
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide
Criteria
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