Trial Outcomes & Findings for Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer (NCT NCT04478123)

Last Updated: 2024-02-14

Results Overview

Common Terminology Criteria for Adverse Events (CTCAE) Version 5.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

up to 42 days

Results posted on

2024-02-14

Participant milestones
Measure	Romiplostim Patients will be enrolled prior to admission for High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT), and they will undergo their planned HDT-AHCT for their respective hematologic malignancy as per institutional standards.
Overall Study STARTED	62
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Romiplostim Patients will be enrolled prior to admission for High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT), and they will undergo their planned HDT-AHCT for their respective hematologic malignancy as per institutional standards.
Overall Study Pt withdrawal or refusal before begin prot txt	2
Overall Study NE	1

Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer

Baseline characteristics by cohort
Measure	Romiplostim n=62 Participants Patients will be enrolled prior to admission for High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT), and they will undergo their planned HDT-AHCT for their respective hematologic malignancy as per institutional standards.
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	62 Participants n=5 Participants

Timeframe: up to 42 days

Common Terminology Criteria for Adverse Events (CTCAE) Version 5.

Outcome measures
Measure	Romiplostim n=59 Participants Patients will be enrolled prior to admission for High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT), and they will undergo their planned HDT-AHCT for their respective hematologic malignancy as per institutional standards.
Number of Days Post HDT-AHCT Requiring Transfusions or Grade 4 CTCAE Thrombocytopenia	6 days Interval 0.0 to 17.0

Timeframe: up to 100 days from AHCT

Outcome measures
Measure	Romiplostim n=59 Participants Patients will be enrolled prior to admission for High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT), and they will undergo their planned HDT-AHCT for their respective hematologic malignancy as per institutional standards.
Number of Platelet Transfusions Per Participant Issued During the AHCT Admission	2 number of platelet transfusions per pt Interval 0.0 to 7.0

Serious events: 0 serious events

Other events: 62 other events

Deaths: 7 deaths

Adverse event data not reported

Other adverse events
Measure	Romiplostim n=62 participants at risk Patients will be enrolled prior to admission for High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT), and they will undergo their planned HDT-AHCT for their respective hematologic malignancy as per institutional standards.
Investigations Lymphocyte count decreased	100.0% 62/62 • Up to 42 days
Investigations Platelet count decreased	100.0% 62/62 • Up to 42 days
Investigations White blood cell decreased	100.0% 62/62 • Up to 42 days
Investigations Neutrophil count decreased	85.5% 53/62 • Up to 42 days
Blood and lymphatic system disorders Anemia	64.5% 40/62 • Up to 42 days
Investigations Blood bilirubin increased	1.6% 1/62 • Up to 42 days
Metabolism and nutrition disorders Hyponatremia	1.6% 1/62 • Up to 42 days

Memorial Sloan Kettering Cancer Center

Phone: 646-608-3771