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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Cancer, Various, NOS

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome 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

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA194-003

NCT ID:

NCT00884546

Start Date:

July 2009

Completion Date:

March 2012

Related Keywords:

  • Advanced Cancer, Various, NOS
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

City of Hope National Medical CenterLos Angeles, California  91010
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Cancer Therapy and Research CenterSan Antonio, Texas  78229
Local InstitutionCorona, California  
Local InstitutionDetroit, Michigan  
The Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland  21231
Oncology Consultants, PAHouston, Texas  77024
John Theurer Cancer CenterHackensack, New Jersey  07601