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OpenTrials
Completed

NCT Number: NCT00884546

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

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.

Completed

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Key information

Conditions

Advanced Cancer, Various, NOS Digestive System Diseases Gastric Outlet Obstruction Gastrointestinal Diseases Pyloric Stenosis Pyloric Stenosis, Hypertrophic Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City Of Hope National Medical Center, Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-833923

Drug

Capsule, Oral, Once daily, 6 months

Lenalidomide

Drug

Capsule, Oral, Once daily, 6 months

Other names: Revlimid

Dexamethasone

Drug

Capsule, Oral, Once a week, 6 months

bortezomib

Drug

Powder, IV, On days 1, 4, 8, 11, 6 months

Other names: Velcade

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Exelixis

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2009
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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