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

This study has been terminated.
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT01002248
First received: October 23, 2009
Last updated: February 14, 2014
Last verified: March 2013
  Purpose

This is a randomized Phase III study to evaluate the efficacy and safety of perifosine when added to the combination of bortezomib and dexamethasone in multiple myeloma patients who have relapsed on a prior bortezomib treatment regimen.


Condition Intervention Phase
Multiple Myeloma
Drug: Perifosine
Drug: Perifosine Placebo
Drug: Bortezomib
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma Patients

Resource links provided by NLM:


Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • Determine the PFS (progression free survival) in patients with multiple myeloma, treated with perifosine, bortezomib and dexamethasone compared to patients treated with placebo, bortezomib and dexamethasone [ Time Frame: 6 - 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: 6 - 24 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 135
Study Start Date: December 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perifosine + Bortezomib + Dexamethasone Drug: Perifosine
Perifosine will be dosed as one 50 mg pill every day of each cycle.
Drug: Bortezomib
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
Drug: Dexamethasone
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Placebo Comparator: Placebo + Bortezomib + Dexamethasone Drug: Perifosine Placebo
Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
Drug: Bortezomib
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
Drug: Dexamethasone
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.

Detailed Description:

A pre-planned interim analysis is expected to take place in Q1 of 2013.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient was previously diagnosed with multiple myeloma based on standard diagnostic criteria.
  • Patients must have relapsed (progressed > 60 days) after their last dose of bortezomib-based therapy. In addition, patients may be relapsed or refractory to other non-bortezomib-based therapies.
  • Patient has received at least 1 but not more than 4 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen.
  • Patients must have adequate organ and marrow function.

Exclusion Criteria:

  • Patients must not be refractory to any bortezomib-containing regimen.
  • History of allergic reactions or intolerance attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine), bortezomib or dexamethasone or any of their components.
  • Prior treatment with perifosine or an investigational proteasome inhibitor.
  • Chemotherapy or other therapy experimental or proven that is or may be active against myeloma within two weeks (14 days) prior to Cycle 1 Day 1.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002248

  Hide Study Locations
Locations
United States, California
LaVerne, California, United States, 91750
San Francisco, California, United States, 94143
San Pablo, California, United States, 94806
United States, Colorado
Aurora, Colorado, United States, 80012
Boulder, Colorado, United States, 80303
Colorado Springs, Colorado, United States, 80909
Denver, Colorado, United States, 80218
Lakewood, Colorado, United States, 80228
Littleton, Colorado, United States, 80120
Longmont, Colorado, United States, 80501
Parker, Colorado, United States, 80138
Pueblo, Colorado, United States, 81008
Thornton, Colorado, United States, 80260
United States, Illinois
Niles, Illinois, United States, 60714
Winfield, Illinois, United States, 60190
United States, Maryland
Baltimore, Maryland, United States, 21201
Columbia, Maryland, United States, 21044
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New Jersey
Morristown, New Jersey, United States, 07960
United States, New York
Great Neck, New York, United States, 11042
United States, North Dakota
Fargo, North Dakota, United States, 58122
United States, Oregon
Portland, Oregon, United States, 97225
Tualatin, Oregon, United States, 97062
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Texas
Bedford, Texas, United States, 76022
Dallas, Texas, United States, 75246
Ft. Worth, Texas, United States, 76104
Kerrville, Texas, United States, 78028
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78217
Tyler, Texas, United States, 75702
United States, Utah
Ogden, Utah, United States, 84403
United States, Virginia
Christiansburg, Virginia, United States, 24073
Roanoke, Virginia, United States, 24014
Salem, Virginia, United States, 24153
United States, Washington
Seattle, Washington, United States, 98133
Spokane, Washington, United States, 99202
Vancouver, Washington, United States, 98686
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
Montreal, Quebec, Canada, H1T 2M4
Quebec City, Quebec, Canada, G1R 2J6
Czech Republic
Brno, Czech Republic, 62500
Prague, Czech Republic, 12821
Ireland
Dublin 24, Ireland
Keryx / AOI Pharmaceuticals Investigative Site
Dublin 7, Ireland
Dublin 8, Ireland
Dublin 9, Ireland
Galway, Ireland
Limerick, Ireland
Sligo, Ireland
Tullamore, Ireland
Waterford, Ireland
Israel
Afula, Israel, 18101
Ashkelon, Israel, 78278
Beer Sheva, Israel, 84101
Haifa, Israel, 31096
Jerusalem, Israel, 91120
Jerusalem, Israel, 91031
Nahariya, Israel, 22100
Petah Tikva, Israel, 49100
Rehovot, Israel, 76100
Tel Aviv, Israel, 64239
Tel-Hashomer, Israel, 52621
Korea, Republic of
Seoul, South Korea, Korea, Republic of, 137-701
Seoul, South Korea, Korea, Republic of, 110-744
Seoul, South Korea, Korea, Republic of, 138-736
Seoul, South Korea, Korea, Republic of, 135-710
Seoul, South Korea, Korea, Republic of, 120-752
Russian Federation
Moscow, Russia, Russian Federation, 129110
Moscow, Russia, Russian Federation, 125284
Saint Petersburg, Russia, Russian Federation, 197022
Saint Petersburg, Russia, Russian Federation, 191024
Samara, Russia, Russian Federation, 443095
Slovakia
Kosice, Slovak Republic, Slovakia, 04166
Spain
Badalona, Spain, 08916
Barcelona, Spain, 08036
Barcelona, Spain, 08025
Barcelona, Spain, 08035
La Laguna, Spain, 38320
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28006
Madrid, Spain, 28034
Pamplona, Spain, 31008
Valencia, Spain, 46026
Zaragoza, Spain, 50009
Sponsors and Collaborators
AEterna Zentaris
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Paul Richardson, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT01002248     History of Changes
Other Study ID Numbers: Perifosine 339
Study First Received: October 23, 2009
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AEterna Zentaris:
Multiple Myeloma
Relapsed multiple myeloma
Refractory multiple myeloma
Relapsed refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on November 20, 2014