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

February 6, 2018 updated by: AEterna Zentaris

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H3A 1A1
      • Quebec City, Quebec, Canada, G1R 2J6
  • Czechia
    • Czech Republic
      • Brno, Czech Republic, Czechia, 62500
      • Prague, Czech Republic, Czechia, 12821
  • Ireland
      • Dublin 24, Ireland
      • Dublin 7, Ireland
        • Keryx / AOI Pharmaceuticals Investigative Site
      • 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, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 135-710
  • Russian Federation
      • Moscow, Russian Federation, 125284
      • Moscow, Russian Federation, 129110
      • Saint Petersburg, Russian Federation, 197022
      • Saint Petersburg, Russian Federation, 191024
      • Samara, Russian Federation, 443095
  • Slovakia
    • Slovak Republic
      • Kosice, Slovak Republic, Slovakia, 04166
  • Spain
      • Badalona, Spain, 08916
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08025
      • La Laguna, Spain, 38320
      • Madrid, Spain, 28006
      • Madrid, Spain, 28040
      • Madrid, Spain, 28034
      • Madrid, Spain, 28041
      • Pamplona, Spain, 31008
      • Valencia, Spain, 46026
      • Zaragoza, Spain, 50009
  • United States
    • California
      • La Verne, California, United States, 91750
      • San Francisco, California, United States, 94143
      • San Pablo, California, United States, 94806
    • 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
    • Illinois
      • Niles, Illinois, United States, 60714
      • Winfield, Illinois, United States, 60190
    • Maryland
      • Baltimore, Maryland, United States, 21201
      • Columbia, Maryland, United States, 21044
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • New Jersey
      • Morristown, New Jersey, United States, 07960
    • New York
      • Great Neck, New York, United States, 11042
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Oregon
      • Portland, Oregon, United States, 97225
      • Tualatin, Oregon, United States, 97062
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • 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, 78229
      • San Antonio, Texas, United States, 78217
      • Tyler, Texas, United States, 75702
    • Utah
      • Ogden, Utah, United States, 84403
    • Virginia
      • Christiansburg, Virginia, United States, 24073
      • Roanoke, Virginia, United States, 24014
      • Salem, Virginia, United States, 24153
    • Washington
      • Seattle, Washington, United States, 98133
      • Spokane, Washington, United States, 99202
      • Vancouver, Washington, United States, 98686
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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: 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.
Drug: Perifosine Placebo
Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 - 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months
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.
6 - 24 months
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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AEterna Zentaris

Collaborators

Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

October 23, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (ESTIMATE)

October 27, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perifosine 339

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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