Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Multiple Myeloma

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase 2 study of perifosine in patients with multiple myeloma. Patients will receive perifosine 150 mg at bedtime (qhs) daily. Patients will be assessed by serum and/or urine-electrophoresis at least every 3 weeks.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00415064

Multiple Myeloma

COMPLETED PHASE1

Safety & Efficacy Study of Perifosine + Bortezomib +/- Dexamethasone for Multiple Myeloma Patients

NCT00401011

Multiple Myeloma Multiple Myeloma in Relapse

COMPLETED PHASE1/PHASE2

Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients

NCT01002248

Multiple Myeloma

TERMINATED PHASE3

Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone

NCT06561854

Multiple Myeloma Relapse Multiple Myeloma

RECRUITING PHASE3

Study of Bortezomib and Dexamethasone With or Without Cyclophosphamide in Patients With Relapsed or Not Controllable Multiple Myeloma

NCT00813150

Multiple Myeloma

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Treatment: Patients will take three 50 mg tablets of perifosine qhs daily with food. All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart. Progressing patients will have dexamethasone 20 mg twice per week added to the perifosine. Patients who experience toxicity may continue on treatment with doses delayed or reduced.

Evaluations: Serum and/or urine-electrophoresis will be evaluated for progression or response at 3 week intervals.

This study will enroll a total of up to 64 patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Perifosine daily

Patients will take three 50 mg tablets of perifosine daily at bedtime with food. Patients will be examined every three weeks. If patients have no progression it is allowed to receive 8 cycles of perifosine

Group Type EXPERIMENTAL

perifosine

Intervention Type DRUG

100 - 150 mg daily

Perifosine daily + Dexa twice per week

Patients will take three 50 mg tablets of perifosine daily at bedtime with food until progression. If progressive disease is confirmed by a second measurement at least one week later the patient will receive a combination of 20 mg twice per week dexamethasone (dexa) and 150 mg perifosine daily at bedtime.

Group Type EXPERIMENTAL

perifosine

Intervention Type DRUG

100 - 150 mg daily

dexamethasone

Intervention Type DRUG

20 mg twice weekly

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

perifosine

100 - 150 mg daily

Intervention Type DRUG

dexamethasone

20 mg twice weekly

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

D-21266 KRX-0401 decadron

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Minor criteria:

1. Bone marrow plasmacytosis (10 to 30% plasma cells)
2. Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
3. Lytic bone lesions
4. Normal immunoglobulin M (IgM) \< 50 mg/dL, IgA \< 100 mg/dL or IgG \< 600 mg/dL.

Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:

1. Any two of the major criteria.
2. Major criterion 1 plus minor criterion b, c or d.
3. Major criterion 3 plus minor criterion a or c.
4. Minor criteria a, b and c or a, b and d.

Exclusion Criteria

1. Renal insufficiency (serum creatinine levels \> 3 mg/dL).
2. Patients who present with either ALT or AST ≥ 2.5 X upper limit of normal.
3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
4. Concomitant therapy medications that include corticosteroids (except as indicated for other medical conditions, or up to 100 mgs of hydrocortisone as premedication for administration of certain medications or blood products) or other chemotherapy that is or may be active against myeloma, or therapy with chemotherapy within 3 weeks prior to Day 1. Nitrosoureas must be discontinued 6 weeks prior to Day 1.
5. Subjects with a hemoglobin \< 8.0 g/dL.
6. Any condition, including laboratory abnormalities, that in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
7. Women of childbearing potential (WCBP) who are pregnant, or breast-feeding or men and women who are not using adequate contraception are excluded.
8. Plasma cell leukemia.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No