Spots Global Cancer Trial Database for Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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