Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Exelixis
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00884546
First received: April 16, 2009
Last updated: July 12, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer, Various, NOS |
Drug: BMS-833923 Drug: Lenalidomide Drug: Dexamethasone Drug: Bortezomib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Bortezomib
Lenalidomide
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
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 [ 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 ] [ Designated as safety issue: Yes ]
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 [ 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | July 2009 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Velcade
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884546
Locations
| United States, California | |
| City Of Hope National Medical Center | |
| Duarte, California, United States, 91010 | |
| Moores Ucsd Cancer Center | |
| La Jolla, California, United States, 92093 | |
| Local Institution | |
| Los Angeles, California, United States, 90048 | |
| United States, Maryland | |
| The Sidney Kimmel Comprehensive Cancer Center | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Michigan | |
| Local Institution | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| John Theurer Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, Texas | |
| Oncology Consultants, Pa | |
| Houston, Texas, United States, 77024 | |
| Cancer Therapy And Research Center | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Exelixis
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00884546 History of Changes |
| Other Study ID Numbers: | CA194-003 |
| Study First Received: | April 16, 2009 |
| Last Updated: | July 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 Dexamethasone 21-phosphate Bortezomib Lenalidomide BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids |
ClinicalTrials.gov processed this record on June 18, 2013