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

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ClinicalTrials.gov Identifier: NCT01002248
Recruitment Status : Terminated
First Posted : October 27, 2009
Last Update Posted : February 9, 2018
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
AEterna Zentaris

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: Perifosine Drug: Perifosine Placebo Drug: Bortezomib Drug: Dexamethasone Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2009
Primary Completion Date : March 2013
Study Completion Date : March 2013


Arm Intervention/treatment
Experimental: Perifosine added to combination

Perifosine added to the combination of Bortezomib and Dexamethasone. Perifosine is is supplied as a film-coated tablet containing 50 mg of active ingredient. Perifosine will be administered orally on an outpatient basis throughout the study. Daily administration will be one 50 mg tablet.

The first dose of perifosine should be taken on the same day that bortezomib and dexamethasone are administered (Cycle 1 Day 1).

Drug: Perifosine
Perifosine will be dosed as one 50 mg pill every day of each cycle.
Other Names:
  • D-21266
  • KRX-0401
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: Perifosine Placebo added to combination
Perifosine placebo added to the combination of Bortezomib and Dexamethasone. The placebo for perifosine is provided in 256 mg white to off-white, round, biconvex film-coated tablets to permit a blinded trial with perifosine 50 mg film coated tablets. Placebo will be administered orally on an outpatient basis throughout the study. Daily administration will be one perifosine placebo tablet. The first dose of placebo should be taken on the same day that bortezomib and dexamethasone are administered (Cycle 1 Day 1).
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.



Primary Outcome Measures :
  1. 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 ]
    Progression-free survival will be defined as the time between randomization and the date of progression that occurred during the Core Phase.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 24 months ]
    OS is defined as time from randomization to death from any cause during the Core Phase of the study.

  2. Overall response rate (ORR) [ Time Frame: 6 - 24 months ]
    The ORR for each treatment arm will be estimated as the proportion of responders, defined as a patient whose best overall response is PR or better during the treatment period, using criteria prospectively established.

  3. Adverse Events [ Time Frame: Up to 24 months ]
    Each AE and SAE term submitted will be mapped to a preferred term (PT) using the MedDRA dictionary. The investigator will classify the severity of AEs using the NCI CTCAE v3.0 and will assess the relationship of each event to each study treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002248


  Hide Study Locations
Locations
United States, California
La Verne, 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
Fort Worth, Texas, United States, 76104
Kerrville, Texas, United States, 78028
San Antonio, Texas, United States, 78217
San Antonio, Texas, United States, 78229
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, H1T 2M4
Montreal, Quebec, Canada, H3A 1A1
Quebec City, Quebec, Canada, G1R 2J6
Czechia
Brno, Czech Republic, Czechia, 62500
Prague, Czech Republic, Czechia, 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, 91031
Jerusalem, Israel, 91120
Nahariya, Israel, 22100
Petah Tikva, Israel, 49100
Rehovot, Israel, 76100
Tel Aviv, Israel, 64239
Tel-Hashomer, Israel, 52621
Korea, Republic of
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 138-736
Russian Federation
Moscow, Russian Federation, 125284
Moscow, Russian Federation, 129110
Saint Petersburg, Russian Federation, 191024
Saint Petersburg, Russian Federation, 197022
Samara, Russian Federation, 443095
Slovakia
Kosice, Slovak Republic, Slovakia, 04166
Spain
Badalona, Spain, 08916
Barcelona, Spain, 08025
Barcelona, Spain, 08035
Barcelona, Spain, 08036
La Laguna, Spain, 38320
Madrid, Spain, 28006
Madrid, Spain, 28034
Madrid, Spain, 28040
Madrid, Spain, 28041
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

Publications:
Richardson PG, Nagler A, Ben-Yehuda D, Badros A, Hari P, Hajek R, Spicka I, Kaya H, Le Blanc R, Yoon SS, Kim K, Martinez-Lopez J, Mittelman M, Shpilberg O, Tothova E, Laubach JP, Ghobria IM, Leiba M, Gatt ME, Sportelli P, Chen M, Anderson KC. Randomized Placebo-Controlled Phase III Study Of Perifosine Combined With Bortezomib and Dexamethasone In Relapsed, Refractory Multiple Myeloma Patients Previously Treated With Bortezomib. Blood 2013 ASH Meeting Proceedings;122:abstract 3189

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT01002248     History of Changes
Other Study ID Numbers: Perifosine 339
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: March 2013

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
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors