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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT05651932
Eligibility Criteria:
Key Inclusion Criteria for Dose-Expansion:
* ≥ 18 years of age
* ECOG score ≤ 1
* Multiple myeloma (as per IMWG)
* ≥ 3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody
* Patients must be refractory to their last prior therapy
* Cohorts A1/A2: Patients must have exhausted available therapeutic options that are expected to provide a meaningful clinical benefit, either through disease relapse, treatment refractory disease, intolerance, or refusal of the therapy
* t(4;14) confirmed by standard of care FISH testing
* Measurable disease, including at least 1 of the following criteria:
* Serum M protein ≥ 0.50 g/dL (by SPEP)
* Serum IgA ≥ 0.50 g/dL (IgA myeloma patients)
* Urine M protein ≥ 200 mg/24 h (by UPEP)
* sFLC involved light chain ≥ 10 mg/dL (100 mg/L) (patients with abnormal sFLC ratio)
* Bone marrow plasma cells ≥ 30% (if only criterion for measurability)
* Agreement to enroll into the REMS program (Cohort D- pomalidomide cohort only)
Key Exclusion Criteria for Dose-Expansion:
* Treatment with the following therapies in the specified time period prior to first dose:
* Carfilzomib in the immediate last prior line of therapy for patients enrolled in Cohorts C1 and C2
* Pomalidomide in the immediate last prior line of therapy for patients enrolled in cohort D
* Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks
* Cellular therapies ≤ 8 weeks
* Autologous transplant \< 100 days
* Allogenic transplant ≤ 6 months, or \> 6 months with active GVHD
* Major surgery ≤ 4 weeks
* Current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone lesion or bone lesions as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm or light chain amyloidosis
* MM with extramedullary disease (applies to Cohorts A1 \& A2: KTX-1001, C1 \& C2: Carfilzomib, and D: Pomalidomide only)
* Active CNS disease
* Inadequate bone marrow function
* Inadequate renal, hepatic, pulmonary, and cardiac function
* Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Permitted prophylactic medications, antimicrobials or antiretroviral therapies defined in protocol.
* Use of acid reducing agents and strong inhibitors or inducers of CYP3A4 within 14 days or 5 half-lives prior to first dose
* Strong CYP1A2 inhibitors for patients receiving pomalidomide (Cohort D)
* Active malignancy not related to myeloma requiring therapy within \< 2 years prior to enrollment, or not in complete remission, with exceptions defined in protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05651932
Study Brief:
Protocol Section:
NCT05651932