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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

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

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

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.

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (the combined complete response [CR] + partial response [PR] + minor response [MR]) following treatment with perifosine

Outcome Time Frame:

Every 3 weeks

Safety Issue:


Principal Investigator

Paul Richardson, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:

Perifosine 212



Start Date:

December 2005

Completion Date:

October 2011

Related Keywords:

  • Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Investigative Site Beverly Hills, California  
Investigative Site Hinsdale, Illinois  
Investigative Site Grand Rapids, Michigan  
Investigative Site Atlanta, Georgia  30322
Investigative Site Boston, Massachusetts  02115
Investigative Site Charlottesville, Virginia  22908