Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma

September 28, 2016 updated by: Bristol-Myers Squibb

A Phase Ib Multiple Ascending Dose Study of BMS-833923 Alone or in Combination With Lenalidomide (Revlimid) Plus Dexamethasone or in Combination With Bortezomib (Velcade) in Subjects With Relapsed or Refractory Multiple Myeloma

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or refractory multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

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

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • La Jolla, California, United States, 92093
        • Moores UCSD Cancer Center
      • Los Angeles, California, United States, 90048
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • The Sidney Kimmel Comprehensive Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Local Institution
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center
    • Texas
      • Houston, Texas, United States, 77024
        • Oncology Consultants, PA
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy and Research Center

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of Multiple Myeloma
  • Men and Women at least 18 years old
  • ECOG status 0-2
  • Last therapeutic or diagnostic treatment at least 21 days prior
  • Bone marrow transplants must have been completed at least 3 months prior
  • Any toxicity from prior therapies must have resolved to Grade ≤1

Exclusion Criteria:

  • Women pregnant or breastfeeding
  • WOCBP unwilling/unable to use acceptable method to avoid pregnancy
  • Uncontrolled medical disorder or active infection
  • Current or recent (w/in 3 months) gastrointestinal disorder
  • Inability to swallow oral medication
  • Inability to be venipunctured
  • Uncontrolled or significant cardiovascular disease
  • Uncontrolled hyperlipidemia
  • Intolerance of lenalidomide or bortezomib if participating in Arms B and C
  • Concurrent therapy with any other investigational product
  • Subjects involuntary incarcerated
  • Subjects detained for treatment of psychiatric or physical illness

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter)
Drug: BMS-833923
Capsule, Oral, Once daily, 6 months
Active Comparator: Arm 2

BMS-833923 (MTD or below)

Lenalidomide (at or below the recommended prescribing dose)

Dexamethasone (40 mg)
Drug: BMS-833923
Capsule, Oral, Once daily, 6 months
Drug: Lenalidomide
Capsule, Oral, Once daily, 6 months
Other Names:
  • Revlimid
Drug: Dexamethasone
Capsule, Oral, Once a week, 6 months
Active Comparator: Arm 3

BMS-833923 (MTD or below)

Bortezomib (at or below the recommended prescribing dose)
Drug: BMS-833923
Capsule, Oral, Once daily, 6 months
Drug: Bortezomib
Powder, IV, On days 1, 4, 8, 11, 6 months
Other Names:
  • Velcade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To establish DLT(s), MTD, and Phase 2 dose range and schedule of BMS-833923 administered alone, in combination with two dose levels of lenalidomide plus dexamethasone, or with two dose levels of bortezomib in subjects with relapsed or refractory MM
Time Frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability of BMS-833923 as a single agent or in combination with two dose levels of lenalidomide plus a fixed low-dose of dexamethasone or in combination with two dose levels of bortezomib
Time Frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
To evaluate the Pharmacokinetics of BMS-833923
Time Frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
To evaluate the Pharmacodynamics effects of BMS-833923
Time Frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Collaborators

Exelixis

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

July 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 16, 2009

First Submitted That Met QC Criteria

April 17, 2009

First Posted (Estimate)

April 20, 2009

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA194-003

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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