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

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Perifosine

Lenalidomide

Dexamethasone

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Perifosine, Lenalidomide, Dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

Primary Outcome Measures

Adverse Events

Secondary Outcome Measures

Clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results

Full Information

NCT ID

NCT00415064

First Posted

December 20, 2006

Last Updated

July 3, 2012

Sponsor

AEterna Zentaris

1. Study Identification

Unique Protocol Identification Number

NCT00415064

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AEterna Zentaris

4. Oversight

Data Monitoring Committee

5. 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: Perifosine 50 mg, lenalidomide 15 mg and dexamethasone 20 mg Perifosine 50 mg, lenalidomide 25 mg and dexamethasone 20 mg Perifosine 100 mg, lenalidomide 15 mg and dexamethasone 20 mg 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Multiple Myeloma, Perifosine, Lenalidomide, Dexamethasone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Perifosine

Intervention Description

Perifosine given in either 50 mg or 100 mg / day

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Intervention Description

Lenalidomide given in either 15 or 25 mg / day

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone given in 20 mg / day

Primary Outcome Measure Information:

Title

Adverse Events

Time Frame

Every cycle

Secondary Outcome Measure Information:

Title

Clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results

Time Frame

Every 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject was previously diagnosed with multiple myeloma based on standard diagnostic criteria, as follows. Major criteria: Plasmacytomas on tissue biopsy. Bone marrow plasmacytosis (> 30% plasma cells). 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrzej J Jakubowiak, MD, PhD

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

Facility Information:

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22640031

Citation

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/refractory multiple myeloma: a Phase I Multiple Myeloma Research Consortium study. Br J Haematol. 2012 Aug;158(4):472-80. doi: 10.1111/j.1365-2141.2012.09173.x. Epub 2012 May 29.

Results Reference

result

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

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