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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT03227432
Eligibility Criteria:
Inclusion Criteria:
* Male or female patient ≥ age 18 years
* Patient is able to understand and has given voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
* Patient has been previously diagnosed with MM based on standard International Myeloma Working Group (IMWG) criteria and currently requires treatment.
* Patient must have received at least two previous lines of therapy for multiple myeloma including lenalidomide or thalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib).
* Patient must have demonstrated disease progression on or within 60 days of completion of the last therapy. Patient has measurable disease defined as at least one of the following:
* Serum M protein ≥ 0.5 g/dL (≥5 g/L)
* Urine M protein ≥200 mg/24 hours
* Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Appendix A)
* Negative serum or urine pregnancy test for women of child-bearing potential
* Screening Laboratory parameters:
* Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L). Granulocyte colony-stimulating factor (GCSF) is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
* Platelet count ≥ 75,000 cells/dL (75 x 109/L) Platelet transfusion is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
* Hemoglobin ≥ 8.0 g/dl ( red blood cell (RBC) transfusions are permitted during the screening period)
* Total Bilirubin ≤ 1.5 X upper limit of normal (ULN) (Patients with known Gilbert Syndrome are allowed to have total bilirubin \< 3.0 mg/dL)
* Aspartate transaminase (AST, or SGOT) and alanine transaminase (ALT, or SGPT) ≤ 3.0x ULN
* Estimated creatinine clearance by Cockcroft-Gault formula ≥ 40 mL/min
* Serum creatinine \< 1.5 X ULN. (Appendix C)
Exclusion Criteria:
* Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy.
* Prior therapy with pomalidomide
* Prior treatment with monoclonal antibodies including elotuzumab
* Prior therapy with anti-programmed death 1 (PD-1) or programmed death-ligand 1 (PD-L1) agents.
* Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
* Prior anti-cancer therapy within 14 days.
* Patient has any Grade 3 or \> unresolved adverse reaction from previous treatment. Previous allogeneic stem cell transplantation with active graft-versus-host disease (GVHD) or being under immunosuppressive therapy in the last 2 months prior to inclusion in the trial.
* Autologous stem cell transplant if \< 12 weeks from enrollment.
* Daily requirement for oral corticosteroids (equivalent to \> 10 mg/day prednisone daily) Inhaled or topical corticosteroids are allowed.
* Patient is human immunodeficiency virus (HIV) positive,.
* Patient is Hepatitis B Surface antigen-positive.
* Patient has active hepatitis C infection.
* Patient has an autoimmune disease. (Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger).
* Any clinically significant, uncontrolled medical conditions that, in the treating Investigator's opinion, would impose excessive risk to the patient or may interfere with compliance or interpretation of the study results. Uncontrolled intercurrent illness may include, but is not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations as determined by treating investigator that would limit compliance with study requirements.
* History of erythema multiforme or severe hypersensitivity to prior IMiD's®
* Inability to tolerate thromboprophylaxis
* Known severe intolerance to prior steroid therapy (Grade 3 or above adverse event which was unresponsive to a dose reduction)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03227432
Study Brief:
Protocol Section:
NCT03227432