Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborator:	Exelixis
Information provided by (Responsible Party):	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00884546

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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

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 ]

Estimated Enrollment:	66
Study Start Date:	July 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (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

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, California
City Of Hope National Medical Center	Recruiting
Duarte, California, United States, 91010
Contact: George Somlo, Site 007 626-256-4673 ext 65897
Moores Ucsd Cancer Center	Recruiting
La Jolla, California, United States, 92093
Contact: Erin Reid, Site 006
Local Institution	Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Site 001
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center	Recruiting
Baltimore, Maryland, United States, 21231
Contact: Carol Ann Huff, Site 002
United States, Michigan
Local Institution	Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Site 011
United States, New Jersey
John Theurer Cancer Center	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: David Siegel, Site 010
United States, Texas
Oncology Consultants, Pa	Recruiting
Houston, Texas, United States, 77024
Contact: Luis Camacho, Site 009 713-275-3242
Cancer Therapy And Research Center	Recruiting
San Antonio, Texas, United States, 78229
Contact: Kevin Kelly, Site 003

Sponsors and Collaborators

Bristol-Myers Squibb

Exelixis

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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:	April 16, 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 May 23, 2012