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: Azacitidine; Type: EXPERIMENTAL; Interventions: Drug: Azacitidine | Arm Label: Conventional Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Physician Choice | Intervention Type: DRUG; Name: Azacitidine; Assigned to Arm(s): Azacitidine | Intervention Type: OTHER; Name: Physician Choice; Assigned to Arm(s): Conventional Care
C: Arm Label: Part A: 300 µg romiplostim; Type: EXPERIMENTAL; Interventions: Drug: Romiplostim | Arm Label: Part A: 700 µg romiplostim; Type: EXPERIMENTAL; Interventions: Drug: Romiplostim | Arm Label: Part A: 1000 µg romiplostim; Type: EXPERIMENTAL; Interventions: Drug: Romiplostim | Arm Label: Part A: 1500 µg romiplostim; Type: EXPERIMENTAL; Interventions: Drug: Romiplostim | Arm Label: Part B: 750 µg romiplostim SC QW; Type: EXPERIMENTAL; Interventions: Drug: Romiplostim | Arm Label: Part B: 750 µg romiplostim SC Q2W; Type: EXPERIMENTAL; Interventions: Drug: Romiplostim | Arm Label: Part B: 750 µg romiplostim IV Q2W; Type: EXPERIMENTAL; Interventions: Drug: Romiplostim | Intervention Type: DRUG; Name: Romiplostim; Assigned to Arm(s): Part A: 1000 µg romiplostim, Part A: 1500 µg romiplostim, Part A: 300 µg romiplostim, Part A: 700 µg romiplostim, Part B: 750 µg romiplostim IV Q2W, Part B: 750 µg romiplostim SC Q2W, Part B: 750 µg romiplostim SC QW
D: Arm Label: 750 mcg AMG 531; Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 | Arm Label: Placebo Part B; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Placebo Part A; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 500 mcg AMG 531; Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 | Arm Label: 750 mcg AMG531 Part B; Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 | Intervention Type: BIOLOGICAL; Name: AMG 531; Assigned to Arm(s): 500 mcg AMG 531, 750 mcg AMG 531, 750 mcg AMG531 Part B | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Part A, Placebo Part B

Answer: A