Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion-dependent Subjects With Myelodysplastic Syndromes Associated With a Del(5q) Cytogenetic Abnormality.
Brief Summary: This study is a multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk Myelodysplastic Syndromes (MDS) associated with a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of the first day of lenalidomide treatment. Subjects will receive lenalidomide in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.


Options:
A: 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
B: 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
C: Arm Label: Lenalidomide; Type: EXPERIMENTAL; Interventions: Drug: lenalidomide | Intervention Type: DRUG; Name: lenalidomide; Assigned to Arm(s): Lenalidomide
D: 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)

Answer: C