A Study of an MMSET Inhibitor in Patients with Relapsed and Refractory Multiple Myeloma

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 and up

Critères de participation

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
* 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.