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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT03111992
Eligibility Criteria:
Inclusion Criteria:
* Must be able to provide written informed consent before any screening procedures.
* Male or female patients ≥18 years of age.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
* Patients with a confirmed diagnosis of multiple myeloma who have received two or more lines of therapy including an IMiD and PI, and are relapsed and/or refractory to their most recent line of therapy. Patients who have received a prior autologous bone marrow transplant and otherwise meet the inclusion criteria are eligible for this study.
* Must have measurable disease defined by at least 1 of the following 3 measurements:
* Serum M-protein ≥ 0.5 g/dL OR
* Urine M-protein ≥ 200 mg/24 hours OR
* Serum free light chain (FLC) \> 100 mg/L of involved FLC
* All patients must be willing to undergo a mandatory serial bone marrow aspirate and/or biopsy at screening and subsequently following treatment for the assessment of biomarker/pharmacodynamics and disease status. Exceptions may be considered after documented discussion with Novartis.
Other inclusion criteria included in the protocol might apply.
Exclusion Criteria:
* Use of systemic chronic steroid therapy (≥10mg /day of prednisone or equivalent), or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal, or ophthalmic steroids are allowed.
* Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.
* Active, known or suspected autoimmune disease other than patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur.
* Patients with prior known toxicity attributed to PD-1 or PDL-1 directed therapy, which led to discontinuation of these agents, will be excluded from the PDR001 containing arms of the study.
* Patients with prior known toxicity from IL-17A directed therapy, which led to discontinuation of the study treatment, will be excluded from CJM112 containing arms of the study.
* Any of the following clinical laboratory results during screening (i.e., within 28 days before the first dose of study treatment):
* Absolute neutrophil count (ANC) \< 1,000/mm3 without growth factor support within 7 days prior to testing
* Platelet count \< 75,000 mm3 without transfusion support within 7 days prior to testing
* Bilirubin \> 1.5 times the upper limit of the normal range (ULN)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the ULN
* Calculated creatinine clearance \< 30 ml/min according to Cockcroft-Gault equation Other exclusion criteria included in the protocol might apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03111992
Study Brief:
Protocol Section:
NCT03111992