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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415064
• Other study ID #: Perifosine 127
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2006
• Last updated: July 3, 2012
• Start date: December 2006
• Est. completion date: July 2012

Study information

• Verified date: November 2011
• Source: AEterna Zentaris
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Perifosine
Perifosine given in either 50 mg or 100 mg / day
• Lenalidomide
Lenalidomide given in either 15 or 25 mg / day
• Dexamethasone
Dexamethasone given in 20 mg / day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AEterna Zentaris

Country where clinical trial is conducted

United States, 

References & Publications (1)

Jakubowiak AJ, Richardson PG, Zimmerman T, Alsina M, Kaufman JL, Kandarpa M, Kraftson S, Ross CW, Harvey C, Hideshima T, Sportelli P, Poradosu E, Gardner L, Giusti K, Anderson KC. Perifosine plus lenalidomide and dexamethasone in relapsed and relapsed/ref — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		Every cycle	Yes
Secondary	Clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results		Every 12 weeks	No