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

Primary Purpose

Advanced Cancer, Various, NOS

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-833923
Lenalidomide
Dexamethasone
Bortezomib
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer, Various, NOS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City Of Hope National Medical Center
  • Moores Ucsd Cancer Center
  • Local Institution
  • The Sidney Kimmel Comprehensive Cancer Center
  • Local Institution
  • John Theurer Cancer Center
  • Oncology Consultants, Pa
  • Cancer Therapy And Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter)

BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg)

BMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
To evaluate the Pharmacokinetics of BMS-833923
To evaluate the Pharmacodynamics effects of BMS-833923

Full Information

First Posted
April 16, 2009
Last Updated
September 28, 2016
Sponsor
Bristol-Myers Squibb
Collaborators
Exelixis
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1. Study Identification

Unique Protocol Identification Number
NCT00884546
Brief Title
Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Exelixis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Various, NOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter)
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg)
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
BMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose)
Intervention Type
Drug
Intervention Name(s)
BMS-833923
Intervention Description
Capsule, Oral, Once daily, 6 months
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
Capsule, Oral, Once daily, 6 months
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Capsule, Oral, Once a week, 6 months
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
Powder, IV, On days 1, 4, 8, 11, 6 months
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
City Of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Moores Ucsd Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Local Institution
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
John Theurer Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Oncology Consultants, Pa
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Cancer Therapy And Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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