Trial Outcomes & Findings for Study of Romiplostim for Chemotherapy Induced Thrombocytopenia (NCT NCT02052882)

NCT ID: NCT02052882

Last Updated: 2024-12-27

Results Overview

The primary therapeutic response is assessed by the platelet count within 3 weeks of treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: within 3 weeks after treatment
• Results posted on: 2024-12-27

Participant Flow

Participant milestones

Measure	Romiplostim All patients will begin weekly romiplostim at 2 mcg/kg, subcutaneously. The romiplostim dose will be titrated on weekly CBC/platelet counts. For titration purposes, the target platelet count is 150,000-200,000/mcL. Treatment can be held up to 16 days if a patient develops an intercurrent medical illness or symptom that is unrelated to study drug therapy. Treatment may be held up to 20 days if the patient unavailable for non- medical reasons, such as vacation or travel. romiplostim
Overall Study STARTED	60
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	Romiplostim All patients will begin weekly romiplostim at 2 mcg/kg, subcutaneously. The romiplostim dose will be titrated on weekly CBC/platelet counts. For titration purposes, the target platelet count is 150,000-200,000/mcL. Treatment can be held up to 16 days if a patient develops an intercurrent medical illness or symptom that is unrelated to study drug therapy. Treatment may be held up to 20 days if the patient unavailable for non- medical reasons, such as vacation or travel. romiplostim
Overall Study Not treated	11
Overall Study Protocol Violation	1
Overall Study Inadequate testing	1

Baseline Characteristics

Study of Romiplostim for Chemotherapy Induced Thrombocytopenia

Baseline characteristics by cohort

Measure	Romiplostim n=60 Participants All patients will begin weekly romiplostim at 2 mcg/kg, subcutaneously. The romiplostim dose will be titrated on weekly CBC/platelet counts. For titration purposes, the target platelet count is 150,000-200,000/mcL. Treatment can be held up to 16 days if a patient develops an intercurrent medical illness or symptom that is unrelated to study drug therapy. Treatment may be held up to 20 days if the patient unavailable for non- medical reasons, such as vacation or travel. romiplostim
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 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	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Region of Enrollment United States	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 3 weeks after treatment

The primary therapeutic response is assessed by the platelet count within 3 weeks of treatment.

Outcome measures

Measure

Romiplostim n=60 Participants All patients will begin weekly romiplostim at 2 mcg/kg, subcutaneously. The romiplostim dose will be titrated on weekly CBC/platelet counts. For titration purposes, the target platelet count is 150,000-200,000/mcL. Treatment can be held up to 16 days if a patient develops an intercurrent medical illness or symptom that is unrelated to study drug therapy. Treatment may be held up to 20 days if the patient unavailable for non- medical reasons, such as vacation or travel. romiplostim

Percentage of Participants Who Achieved Platelet Counts of ≥ 100,000/mcL

93 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Assessment of toxicity will be based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Outcome measures

Measure

Romiplostim n=60 Participants All patients will begin weekly romiplostim at 2 mcg/kg, subcutaneously. The romiplostim dose will be titrated on weekly CBC/platelet counts. For titration purposes, the target platelet count is 150,000-200,000/mcL. Treatment can be held up to 16 days if a patient develops an intercurrent medical illness or symptom that is unrelated to study drug therapy. Treatment may be held up to 20 days if the patient unavailable for non- medical reasons, such as vacation or travel. romiplostim

Number of Participants Evaluated for Toxicity

60 Participants

Adverse Events

Romiplostim

Serious events: 0 serious events

Other events: 6 other events

Deaths: 53 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Romiplostim n=60 participants at risk All patients will begin weekly romiplostim at 2 mcg/kg, subcutaneously. The romiplostim dose will be titrated on weekly CBC/platelet counts. For titration purposes, the target platelet count is 150,000-200,000/mcL. Treatment can be held up to 16 days if a patient develops an intercurrent medical illness or symptom that is unrelated to study drug therapy. Treatment may be held up to 20 days if the patient unavailable for non- medical reasons, such as vacation or travel. romiplostim
Vascular disorders Thromboembolic event	3.3% 2/60 • 1 year
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 1/60 • 1 year
Investigations Blood bilirubin increase	1.7% 1/60 • 1 year
Respiratory, thoracic and mediastinal disorders Cough	1.7% 1/60 • 1 year
Skin and subcutaneous tissue disorders Pruritus	1.7% 1/60 • 1 year

Additional Information

Dr. Cy Wilkins, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-608-3720

Email: wilkinsc@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place