Clinical trial NCT00884546: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer, Various, NOS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Exelixis
First posted: 2009-04-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 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 outcomes:
measure: 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
timeFrame: 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
measure: To evaluate the Pharmacokinetics of BMS-833923
timeFrame: 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
measure: To evaluate the Pharmacodynamics effects of BMS-833923
timeFrame: 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
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City Of Hope National Medical Center
state: California
city: La Jolla
country: United States
facility: Moores Ucsd Cancer Center
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Detroit
country: United States
facility: Local Institution
state: Michigan
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: Houston
country: United States
facility: Oncology Consultants, Pa
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy And Research Center
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: