Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Talacotuzumab; Daratumumab
Intervention description: Talacotuzumab 9 mg/kg will be administered as an IV infusion.; Daratumumab 16 mg/kg will be administered as an IV infusion.
Intervention MeSH terms: Daratumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of the study is to evaluate the efficacy (transfusion independence [TI]) of
      talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or
      intermediate-1 risk Myelodysplastic Syndrome (MDS) whose disease has relapsed during
      treatment with or is refractory to Erythropoiesis-Stimulating Agent (ESAs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Myelodysplastic Syndrome (MDS) according to World Health Organization (WHO) criteria
             confirmed by bone marrow aspirate and biopsy within 12 weeks prior to first dose. A
             local laboratory report from this diagnostic bone marrow aspirate and biopsy must be
             approved by the sponsor

          -  International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk MDS

          -  Red blood cell (RBC) transfusion dependent, 1) Received at least 4 units of RBCs over
             any 8 consecutive weeks during the 16 weeks prior to randomization, 2) Pretransfusion
             Hb must have been less than or equal to (<=)9.0 gram per deciliter (g/dL)

          -  Adequate iron stores, defined as transferrin saturation greater than 20 percent (%)
             and serum ferritin greater than 400 nanogram per Milliliter (ng/mL), measured within
             the screening period, or adequate iron stores as demonstrated by recent (within 12
             weeks prior to first dose) bone marrow examination with iron stain

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

        Exclusion Criteria:

          -  Known allergies, hypersensitivity, or intolerance to talacotuzumab and daratumumab or
             their excipients

          -  Received any chemotherapy, immunomodulatory or immunosuppressive therapy,
             corticosteroids (greater than [>]30 milligram per day [mg/day] prednisone or
             equivalent) within 28 days prior to randomization

          -  Received other treatments for MDS within 28 days prior to first dose (example [eg],
             azacitidine, decitabine, lenalidomide, Erythropoiesis-Stimulating Agent (ESA) (8 weeks
             for long-acting ESAs)

          -  History of hematopoietic stem cell transplant

          -  Del(5q) karyotype unless treatment with lenalidomide has failed. Failure is defined as
             either: 1) having received at least 3 months of lenalidomide treatment without RBC
             transfusion benefit (International Working Group [IWG] 2006); 2) progression or
             relapse after hematologic improvement with lenalidomide (IWG 2006); 3) discontinuation
             of lenalidomide due to toxicity; or 4) unable to receive lenalidomide due to a
             contraindication. Source documentation for lenalidomide treatment failure must be
             verified by the sponsor