Blood

A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM)(Excaliber-RRMM)(CC-220-MM-002)

MOA: Berdomide is a high-affinity CELMod agent with anti-neoplastic and immunomodulatory properties. Higher activity than Lenolidamide

Key Eligibility Criteria:

• Documented diagnosis of MM and measurable disease
• Subject has received 1 to 2 prior lines of therapy and achieved partial response or better to at least 1
• ECOG score of ≤ 2
• Subjects with prior CD38-directed & bortezomib therapy if below are fulfilled:
  a) Best response achieved was at least MR(bortezomib) or PR(CD38)
  b) Did not progress while receiving therapy
  c) Did not discontinue due to a related AE(CD38)
  d) Last dose of daratumumab was ≥ 3 months prior to randomization(CD38)
• Subjects that received prior therapy with Iberdomide are excluded

A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination with Obinutuzumab or Acalabrutinib With Different Ramp-Up Periods in Previously Untreated Subjects with CLL (M24-287)

MOA: enetoclax is a BCL2 inhibitor that directly targets the BCL-2 protein, modulating the mitochondrial apoptotic pathway and inducing tumor cell death.

Key Eligibility Criteria:

• Documented, previously untreated CLL requiring treatment
  • Diagnosis of previously untreated SLL that requires treatment can be considered as CLL for eligibility
  • Cannot have progressed to aggressive NHL or have known CNS involvement
• ECOG ≤ 2
• Subjects with history of confirmed PML are excluded
• Subjects with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia are excluded

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma (OPTec/OPTal)

MOA: Teclistamab targets the CD3 receptor complex on T cells and BCMA on B-lineage cells. Talquetamab targets the D3 receptor complex in T cells and GPRC5D expressing cells.

Key Eligibility Criteria:

• Must have documented diagnosis of MM according to the IMWG diagnostic criteria
• Must have received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody
• Patients with a high tumor burden, defined as having ≥60% plasma cell infiltrate on the bone marrow biopsy or aspirate, whichever is higher, or with multiple extramedullary disease sites or plasmacytomas are excluded
• Patients with a rapidly progressing disease per investigator assessment are excluded

A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide (MajesTEC-9)

MOA: Teclistamab is a BCMA x CD3 bispecific antibody.

Key Eligibility Criteria:

• Documented diagnosis of relapsed or refractory multiple myeloma that is measurable
• Subject should have received 1 to 3 prior lines of antimyeloma therapy
  • Minimum of 2 consecutive cycles of an anti-CD38 monoclonal antibody at approved dosing schedule
  • Minimum of 2 consecutive cycles of lenalidomide in any prior line
• ECOG score ≤ 2
• Subjects that received any prior BCMA-directed therapy are excluded
• Subject that received prior pomalidomide therapy and do not meet bortezomib retreatment criteria are not allowed on PCd
• Subjects with prior carfilzomib therapy are not allowed on Kd

A Phase 2 study to evaluate the efficacy and safety of selinexor monotherapy in subjects with JAK inhibitor (JAKi)-naïve myelofibrosis and moderate thrombocytopenia

Brief Summary: The main purpose of this study with corresponding optional expansion is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.

Key Eligibility Criteria:

• A diagnosis of MF or post-ET or post-PV MF
• Measurable splenomegaly during the screening period 
• ECOG Performance Status less than or equal to (<=) 2
• More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase) excluded
• Previous treatment with JAK inhibitors for MF excluded
• Previous treatment with selinexor or other XPO1 inhibitors excluded

A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis

Brief Summary: This is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants.

Key Eligibility Criteria:

• A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF
• Active symptoms of MF as determined by presence of at least 2 symptoms using the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.
• Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk.
• Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (>=) 450 cubic centimeter (cm^3) .
• Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (<=) 2.
• More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase) excluded.
• Previous treatment with JAK inhibitors for MF excluded.
• Previous treatment with selinexor or other XPO1 inhibitors excluded.

A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance) (IM048022)

MOA: Cereblon E3 ubiquitin ligase modulating agent, IMiD (thalidomide and its analogues)

Key Eligibility Criteria:

• Confirmed diagnosis of symptomatic multiple myeloma (MM)
• Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2
• Received 3 to 6 cycles of an induction therapy that includes a PI and IMiD with/without a CD38 monoclonal antibody/VCd and followed by a single/tandem ASCT
• Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation
• Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy excluded
• Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma excluded