Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT01632150
Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Key Inclusion Criteria:
* Confirmed diagnosis of previously treated multiple myeloma with progression documented by criteria of the International Myeloma Working Group after or during the most recent therapy
* Patient received 5 or fewer prior lines of therapy
* Eastern Cooperative Oncology Group performance status of 0 or 1 (safety lead-in cohort) or 0 to 2 (additional patients)
* Measurable disease as defined by at least 1 of the following:
* Serum immunoglobulin (Ig)G, IgA, IgM, or monoclonal (M) protein level ≥0.5 g/dL or serum IgD M protein level ≥0.05 g/dL; or
* Urine M protein level ≥200 mg excreted in a 24-hour collection sample; or
* Involved serum free light chain level ≥10 mg/dL, provided the free light chain ratio is abnormal
Key Exclusion Criteria:
* Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
* Monoclonal gammopathy of undetermined significance, smoldering myeloma, or Waldenström's macroglobulinemia
* Left ventricular ejection fraction by echocardiogram or Multi Gated Acquisition ≤50%
* Electrocardiogram finding of QTc ≥450 msec
* Active plasma cell leukemia (defined as either 20% of peripheral white blood cells, composed of plasma/CD138+ cells or an absolute plasma cell count of 2\*10\^9/L)
* Diagnosis of nonsecretory myeloma
* Active hepatitis A, B, or C virus infection
* Grade ≥2 neuropathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01632150
Study Brief:
Protocol Section:
NCT01632150