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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00415064

Enrollment

Registered

2006-12-22

Start date

2006-12-31

Completion date

2012-07-31

Last updated

2012-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Perifosine, Lenalidomide, Dexamethasone

Brief 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.

Detailed description

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.

Interventions

DRUGPerifosine

Perifosine given in either 50 mg or 100 mg / day

DRUGLenalidomide

Lenalidomide given in either 15 or 25 mg / day

DRUGDexamethasone

Dexamethasone given in 20 mg / day

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse Events	Every cycle

Secondary

Measure	Time frame
Clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results	Every 12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026