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

NCT ID: NCT00415064

Last Updated: 2012-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Keywords

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Multiple Myeloma Perifosine Lenalidomide Dexamethasone

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Perifosine

Perifosine given in either 50 mg or 100 mg / day

Intervention Type DRUG

Lenalidomide

Lenalidomide given in either 15 or 25 mg / day

Intervention Type DRUG

Dexamethasone

Dexamethasone given in 20 mg / day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AEterna Zentaris

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrzej J Jakubowiak, MD, PhD

Role: STUDY_CHAIR

University of Michigan

Locations

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Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22640031 (View on PubMed)

Other Identifiers

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Perifosine 127

Identifier Type: -

Identifier Source: org_study_id