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

Multiple Myeloma Clinical Trial

Official title:

An Open-Label Phase II Study of the Safety and Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375791
• Other study ID #: Perifosine 212
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2006
• Last updated: February 27, 2018
• Start date: December 2005
• Est. completion date: October 2011

Study information

• Verified date: February 2012
• Source: AEterna Zentaris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• perifosine
100 - 150 mg daily
• dexamethasone
20 mg twice weekly

Locations

Country	Name	City	State
United States	Investigative Site	Ann Arbor	Michigan
United States	Investigative Site	Atlanta	Georgia
United States	Investigative Site	Berkeley	California
United States	Investigative Site	Boston	Massachusetts
United States	Investigative Site	Charlottesville	Virginia
United States	Investigative Site	Chicago	Illinois
United States	Investigative Site	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
AEterna Zentaris

Country where clinical trial is conducted

United States, 

References & Publications (1)

Blood (ASH Annual Meeting Abstracts) 2007 110: Abstract 1164 © 2007 American Society of Hematology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (the combined CR + PR + MR) with treatment perifosine	To determine the response rate (the combined Complete Response (CR) + Partial Response (PR) + Minor Response (MR) following treatment with perifosine in patients with multiple myeloma who have relapsed following Initial front-line therapy and are refractory to their most recent therapy.	Every 3 weeks
Secondary	Response rate (CR + PR + MR) with combination therapy	To determine the response rate (CR + PR + MR) following treatment with combination therapy with perifosine plus dexamethasone in patients with multiple myeloma who have relapsed or were refractory to their most recent therapy before study enrollment, and failed to respond to or have relapsed following treatment with perifosine alone.	Every 3 weeks
Secondary	Assess the safety and tolerability of perifosine alone and in combination	To assess the safety and tolerability of perifosine alone and in combination with dexamethasone in patients with multiple myeloma.	Every 3 weeks
Secondary	Obtain correlative data in patients with multiple myeloma treated with perifosine and in combination	To obtain correlative data in patients with multiple myeloma treated with perifosine alone and in combination with dexamethasone.	Every 3 weeks