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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The purpose of this study is to see if the study drug, romiplostim, helps low platelet count caused by the standard blood cancer treatment of chemotherapy and autologous hematopoietic cell transplantation. This study will also look at whether romiplostim can decrease the number of times the participant needs to return to the clinic for platelet transfusions to treat their low platelet count. In addition, the researchers will determine how safe it is to give romiplostim to people with blood cancer who have received treatment with chemotherapy and autologous hematopoietic cell transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| romiplostim | Experimental | 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. Regardless of the conditioning regimen received, all patients will receive romiplostim 3.0 mcg/kg SC on Day +1 and romiplostim 2.0 mcg/kg SC on Day +8 after HDT-AHCT. Beyond Day +8, patients will be treated until platelet count is >50,000/mcL, without any platelet transfusions in the prior 48 hours. All doses after the second romiplostim dose will be titrated as per Table 3, based on weekly CBC/platelet counts. No patient will receive more than six doses of romiplostim, even if platelets have not corrected by Day +42. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romiplostim | Drug | Romiplostim 3.0 mcg/kg SC on Day +1 and Romiplostim 2.0 mcg/kg SC on Day +8 after HDT-AHCT. Beyond Day +8, patients will be treated weekly until platelet count is >50,000/mcL, without any platelet transfusions in the prior 48 hours. All doses after the second Romiplostim dose will be titrated as per Table 3, based on weekly CBC/platelet counts. Patients will receive a maximum of six weekly doses of romiplostim. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Post HDT-AHCT Requiring Transfusions or Grade 4 CTCAE Thrombocytopenia | Common Terminology Criteria for Adverse Events (CTCAE) Version 5. | up to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Platelet Transfusions Per Participant Issued During the AHCT Admission | up to 100 days from AHCT |
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Inclusion Criteria:
Adult patients ≥ 18 years old diagnosed with multiple myeloma (MM), any subtype of Hodgkin lymphoma (HL), or any subtype of non-Hodgkin lymphoma (NHL)
Adequate organ function is required, defined as follows:
Ability to provide written informed consent.
Patients undergoing HDT-AHCT.
Exclusion Criteria:
Patients with a previous diagnosis of a myeloid malignancy.
Patients for whom the treating oncologist will be using a non-standard platelet transfusion threshold during the AHCT.
Patients with a history of a prior symptomatic or incidental venous thromboembolic event (such as DVT or pulmonary embolism) within the prior 6 months are eligible if they are on and tolerating anti-coagulation, or greater than 6 months ago are eligible if they completed or are on and tolerating anti-coagulation.
°A venous thrombotic event associated with a central venous catheter will not make the patient ineligible.
Patients with a history of symptomatic arterial thrombotic events such as myocardial infarction, ischemic cerebral vascular accident or transient ischemic attack in the past 6 months are ineligible.
Patients who had been diagnosed with Immune Thrombocytopenic Purpura (ITP) at any time prior to the AHCT are ineligible.
Patients with a serious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring IV antibiotics.
Previous use of romiplostim, PEGylated recombinant human megakaryocyte growth and development factor, eltrombopag, recombinant human TPO, any other TPO receptor agonist, or any investigational platelet producing agent.
Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 30 days after treatment discontinuation or longer if required by prescribing information for chemotherapy received during the study.
Patients unwilling to use highly effective contraception during the study period and for the duration required by prescribing information for chemotherapy(ies) administered during the study.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Scordo, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey | 07920 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36409612 | Derived | Scordo M, Gilbert LJ, Hanley DM, Flynn JR, Devlin SM, Nguyen LK, Ruiz JD, Shah GL, Sauter CS, Chung DJ, Landau HJ, Lahoud OB, Lin RJ, Dahi PB, Perales MA, Giralt SA, Soff GA. Open-label pilot study of romiplostim for thrombocytopenia after autologous hematopoietic cell transplantation. Blood Adv. 2023 Apr 25;7(8):1536-1544. doi: 10.1182/bloodadvances.2022007838. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Sep 15, 2021 |
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A single-center, open-label, pilot study of romiplostim for patients undergoing HDT-AHCT.
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|
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (Limited Protocol Activities) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York | 11553 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | 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 |
|
| 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 | Number of Days Post HDT-AHCT Requiring Transfusions or Grade 4 CTCAE Thrombocytopenia | Common Terminology Criteria for Adverse Events (CTCAE) Version 5. | Posted | Median | Full Range | days | up to 42 days |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Platelet Transfusions Per Participant Issued During the AHCT Admission | Posted | Median | Full Range | number of platelet transfusions per pt | up to 100 days from AHCT |
|
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Up to 42 days
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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 | 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. | 7 | 62 | 0 | 62 | 62 | 62 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Scordo, MD | Memorial Sloan Kettering Cancer Center | 646-608-3771 | scordom@mskcc.org |
| Nov 3, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C488777 | romiplostim |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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