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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
This study is to determine if using weekly romiplostim injections will improve the patient's platelet count more effectively than simply waiting for the platelets to improve on its own, and if romiplostim will also allow the patient to receive at least 2 further cycles of chemotherapy without thrombocytopenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Romiplostim | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| romiplostim | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Platelet Counts of ≥ 100,000/mcL | The primary therapeutic response is assessed by the platelet count within 3 weeks of treatment. | within 3 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Evaluated for Toxicity | Assessment of toxicity will be based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | 1 year |
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Inclusion Criteria:
1. Patients (18 years of age or greater) with active non-hematological cancer:
A. The patients have previously received a chemotherapy regimen including one or more of the following agents:
2. Patients who have not had any cytotoxic chemotherapy within 14 days of beginning the study.
3. Thrombocytopenia:.
A. Defined as platelet count <100,000/mcL.
B. The patient will have had at least 2 CBCs with platelet counts <100,000/mcL separated by at least 4 weeks, and no platelet count ≥100,000/mcL in the prior 6 week period, despite (1) delay, or (2) modification of chemotherapeutic regimen.
C. A platelet count of >100,000/mcL, that follows within 7 days of a platelet transfusion, will not make the patient ineligible, as long as one or more subsequent platelet counts confirms thrombocytopenia (<100,000/mcL).
D. Patients have undergone bone marrow aspirate and biopsy or peripheral blood test in the prior 3 months without evidence of leukemia or myelodysplasia by fluorescent in situ-hybridization (FISH) E. Dysplastic changes, based on morphology only, will not exclude the patient if FISH panel for MDS is normal.
4.KPS ≥ 50 or ECOG performance status ≤2 .
5.Ability to provide written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cy Wilkins, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| Memorial Sloan Kettering Monmouth |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31545663 | Derived | Soff GA, Miao Y, Bendheim G, Batista J, Mones JV, Parameswaran R, Wilkins CR, Devlin SM, Abou-Alfa GK, Cercek A, Kemeny NE, Sarasohn DM, Mantha S. Romiplostim Treatment of Chemotherapy-Induced Thrombocytopenia. J Clin Oncol. 2019 Nov 1;37(31):2892-2898. doi: 10.1200/JCO.18.01931. Epub 2019 Sep 23. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Platelet Counts of ≥ 100,000/mcL | The primary therapeutic response is assessed by the platelet count within 3 weeks of treatment. | Posted | Number | percentage of participants | within 3 weeks after treatment |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolic event | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cy Wilkins, MD | Memorial Sloan Kettering Cancer Center | 646-608-3720 | wilkinsc@mskcc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2021 | Nov 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C488777 | romiplostim |
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| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Cancer Center @ Suffolk | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants Evaluated for Toxicity | Assessment of toxicity will be based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 53 |
| 60 |
| 0 |
| 60 |
| 6 |
| 60 |
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blood bilirubin increase | Investigations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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