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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00884546

Enrollment

Registered

2009-04-20

Start date

2009-07-31

Completion date

2012-03-31

Last updated

2016-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer, Various, NOS

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.

Interventions

DRUGBMS-833923

Capsule, Oral, Once daily, 6 months

DRUGLenalidomide

Capsule, Oral, Once daily, 6 months

DRUGDexamethasone

Capsule, Oral, Once a week, 6 months

DRUGBortezomib

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	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

Measure	Time frame
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	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
To evaluate the Pharmacokinetics of BMS-833923	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
To evaluate the Pharmacodynamics effects of BMS-833923	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026