Blood

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 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 1b, Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects with Autoimmune Cytopenias (RUBY-4)

Brief Summary: The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and potentially beneficial in treating these diseases. 

Key Eligibility Criteria:

• Immune Thrombocytopenia (ITP):
  • Documented persistent or chronic primary ITP of at least 12 weeks duration from diagnosis to Cycle 1 Day 1
  • History of failure or relapse to at least 2 treatment regimens for ITP
• Warm Autoimmune Hemolytic Anemia (wAIHA):
  • Diagnosis of primary wAIHA of at least 12 weeks duration documented with a current or prior positive direct antiglobulin test (DAT) for anti-IgG (±C3d)
  • Documented history of anemia with hemoglobin ≤10 g/dL
• Cold Agglutinin Disease (CAD):
  • Diagnosis of primary CAD of at least 12 weeks duration 
  • Documented history of anemia with hemoglobin ≤10 g/dL
• Secondary AIHA, CAD, or ITP 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