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Complete title: 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
|Research Study Number||20111816|
|Principal Investigator||Pamela Becker, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
- Genders Eligible for Study: Both
- 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.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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.
Other exclusion criteria may apply.
Hematologic Malignancies; Multiple Myeloma (MM)
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