Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim (AMG 531) Treatment of Subjects With Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents
Brief Summary: The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.


Options:
A: Arm Label: Dose level 1 500 AMG 531 (Part A - azacitidine); Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 (Romiplostim), Drug: Azacitidine | Arm Label: Dose level 1 750 AMG 531 (Part B - decitabine); Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 (Romiplostim), Drug: Decitabine | Arm Label: Dose level 2 750 AMG 531 (Part A - azacitidine); Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 (Romiplostim), Drug: Azacitidine | Arm Label: Placebo (Part A - azacitidine); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Azacitidine | Arm Label: Placebo (Part B - decitabine); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Decitabine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (Part A - azacitidine), Placebo (Part B - decitabine) | Intervention Type: BIOLOGICAL; Name: AMG 531 (Romiplostim); Assigned to Arm(s): Dose level 1 500 AMG 531 (Part A - azacitidine), Dose level 1 750 AMG 531 (Part B - decitabine), Dose level 2 750 AMG 531 (Part A - azacitidine) | Intervention Type: DRUG; Name: Azacitidine; Assigned to Arm(s): Dose level 1 500 AMG 531 (Part A - azacitidine), Dose level 2 750 AMG 531 (Part A - azacitidine), Placebo (Part A - azacitidine) | Intervention Type: DRUG; Name: Decitabine; Assigned to Arm(s): Dose level 1 750 AMG 531 (Part B - decitabine), Placebo (Part B - decitabine)
B: Arm Label: WAS patients receiving Promacta; Type: EXPERIMENTAL; Interventions: Drug: Promacta | Arm Label: WAS patients for blood drawing only; Type: EXPERIMENTAL; Interventions: Diagnostic Test: blood drawing in patients with WAS | Arm Label: healthy children for blood drawing only; Type: PLACEBO_COMPARATOR; Interventions: Diagnostic Test: blood drawing in healthy controls | Intervention Type: DRUG; Name: Promacta; Assigned to Arm(s): WAS patients receiving Promacta | Intervention Type: DIAGNOSTIC_TEST; Name: blood drawing in patients with WAS; Assigned to Arm(s): WAS patients for blood drawing only | Intervention Type: DIAGNOSTIC_TEST; Name: blood drawing in healthy controls; Assigned to Arm(s): healthy children for blood drawing only
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Biological: Therapeutic platelet transfusion | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Biological: Prophylactic platelet transfusion | Intervention Type: BIOLOGICAL; Name: Prophylactic platelet transfusion; Assigned to Arm(s): 2 | Intervention Type: BIOLOGICAL; Name: Therapeutic platelet transfusion; Assigned to Arm(s): 1
D: Arm Label: Arm B; Type: EXPERIMENTAL; Interventions: Drug: Eltrombopag | Arm Label: Arm C; Type: EXPERIMENTAL; Interventions: Drug: Eltrombopag | Arm Label: Arm D; Type: EXPERIMENTAL; Interventions: Drug: Eltrombopag | Arm Label: Arm E; Type: EXPERIMENTAL; Interventions: Drug: Eltrombopag | Arm Label: Arm A; Type: OTHER; Interventions: Drug: Eltrombopag | Intervention Type: DRUG; Name: Eltrombopag; Assigned to Arm(s): Arm A | Intervention Type: DRUG; Name: Eltrombopag; Assigned to Arm(s): Arm B, Arm C, Arm D, Arm E

Answer: A