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A Phase 1b, Open-label, Multicenter Study of (BMS-936564) in Combination With Lenalidomide (Revlimid) Plus Low-dose Dexamethasone, or With Bortezomib (Velcade) Plus Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

A Phase 1b, Open-label, Multicenter Study of (BMS-936564) in Combination With Lenalidomide (Revlimid) Plus Low-dose Dexamethasone, or With Bortezomib (Velcade) Plus Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma


Inclusion Criteria:



- Subjects must have confirmed diagnosis of multiple myeloma with measurable disease
Excluded are subjects with only plasmacytomas, plasma cell leukemia, or non-secretory
myeloma.

- Disease must be assessed within 28 days prior to treatment initiation.

- Subjects must have evidence of relapsed or relapsed/refractory disease.

- Subjects must have received at least 2 prior regimens for multiple myeloma.

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2.

- Subjects must have received last treatment (ie, chemotherapy, radiotherapy,
biological, immunotherapy or investigational agent [therapeutic or diagnostic]) at
least 14 days prior to treatment initiation.

Exclusion Criteria:

- A serious uncontrolled medical disorder or active infection.

- Current or recent (within 3 months) gastrointestinal disease or condition that could
impact the absorption of orally-administered drug.

- Inability to swallow oral medication.

- Uncontrolled or significant heart disease.

- Any other malignancy, excluding basal or squamous cell carcinoma of the skin,
cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer
stage 0, from which the subject has not been disease-free for at least 3 years.

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:

Determination of maximum tolerated dose

Outcome Time Frame:

42 days in Arm A

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:

CA212-002

NCT ID:

NCT01359657

Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • Relapsed
  • Refractory
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
University of Washington School of MedicineSeattle, Washington  98195
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Dana Farber Cancer InstituteBoston, Massachusetts  02115