NCT00375791

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Dec 2005

Typical duration for phase_2 multiple-myeloma

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2012

Enrollment Period

5 years

First QC Date

September 11, 2006

Last Update Submit

February 27, 2018

Conditions

Multiple Myeloma

Keywords

Relapsed Multiple MyelomaRefractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Response rate (CR + PR + MR) with combination therapy

    Every 3 weeks

  • Assess the safety and tolerability of perifosine alone and in combination

    Every 3 weeks

  • Obtain correlative data in patients with multiple myeloma treated with perifosine and in combination

    Every 3 weeks

Study Arms (2)

Perifosine daily

EXPERIMENTAL

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

Drug: perifosine

Perifosine daily + Dexa twice per week

EXPERIMENTAL

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.

Drug: perifosineDrug: dexamethasone

Interventions

perifosineDRUG

100 - 150 mg daily

Also known as: D-21266, KRX-0401
Perifosine dailyPerifosine daily + Dexa twice per week
dexamethasoneDRUG

20 mg twice weekly

Also known as: decadron
Perifosine daily + Dexa twice per week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Minor criteria:
  • Bone marrow plasmacytosis (10 to 30% plasma cells)
  • Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
  • Lytic bone lesions
  • 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:
  • Any two of the major criteria.
  • Major criterion 1 plus minor criterion b, c or d.
  • Major criterion 3 plus minor criterion a or c.
  • Minor criteria a, b and c or a, b and d.

You may not qualify if:

  • Renal insufficiency (serum creatinine levels \> 3 mg/dL).
  • Patients who present with either ALT or AST ≥ 2.5 X upper limit of normal.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
  • 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.
  • Subjects with a hemoglobin \< 8.0 g/dL.
  • 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.
  • Women of childbearing potential (WCBP) who are pregnant, or breast-feeding or men and women who are not using adequate contraception are excluded.
  • Plasma cell leukemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Investigative Site

Berkeley, California, 94704, United States

Location

Investigative Site

Duarte, California, 91010, United States

Location

Investigative Site

Atlanta, Georgia, 30322, United States

Location

Investigative Site

Chicago, Illinois, 60611, United States

Location

Investigative Site

Boston, Massachusetts, 02115, United States

Location

Investigative Site

Ann Arbor, Michigan, 48103, United States

Location

Investigative Site

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

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

    RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

perifosineDexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Paul Richardson, M.D

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 13, 2006

Study Start

December 1, 2005

Primary Completion

December 1, 2010

Study Completion

October 1, 2011

Last Updated

February 28, 2018

Record last verified: 2012-02

Locations

US(7)