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 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT01962792
Eligibility Criteria:
Inclusion Criteria:
* Measurable disease of MM as defined by at least ONE of the following:
1. Serum monoclonal protein (SPEP) ≥1 g/dL
2. Urine M-protein ≥200 mg/24 hrs
3. Serum free light chain (SFLC): involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal kappa to lambda serum free light chain ratio
* Relapsed or relapsed and refractory MM after receiving at least 2 previous therapies, including an immunomodulator and bortezomib and had either no response or documented disease progression (according to IMWG criteria) to the most recent treatment regimen
* Adequate hematologic, hepatic, and renal function
* ECOG performance status of 0-2
Inclusion Criteria for Phase 2 Sub-study Cohort:
* Must meet all inclusion criteria defined in main study and in addition the following criteria must be met:
* Subject must have received a regimen containing carfilzomib in combination with dexamethasone as their most recent line of therapy and have:
1. Achieved less than a partial response (\<PR) following at least 4 cycles and are without evidence of progression disease (PD).
OR
2. Disease progression following an initial confirmed response of MR or better to the combination (according to IMWG response criteria).
Exclusion Criteria:
* Subject must not have primary refractory disease
* Plasma cell leukemia, primary amyloidosis or POEMS syndrome
* Unable to swallow capsules or disease significantly affecting gastrointestinal function
* Requires anti-coagulation with warfarin or a vitamin K antagonist
* Requires treatment with strong CYP3A inhibitors
Exclusion Criteria for Phase 2 Sub-study Cohort:
* Must not meet any exclusion criteria defined in main study except for exclusion criteria "Subject must not have primary refractory disease" which is related to prior carfilzomib
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01962792
Study Brief:
Protocol Section:
NCT01962792