Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer
An Open-Label, Pilot Study of Romiplostim for Conditioning Regimen-Related Thrombocytopenia After High-Dose Therapy and Autologous Hematopoietic Cell Transplantation
1 other identifier
interventional
62
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Jul 2020
Shorter than P25 for phase_2 multiple-myeloma
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 14, 2020
CompletedFirst Submitted
Initial submission to the registry
July 15, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2023
CompletedResults Posted
Study results publicly available
February 14, 2024
CompletedFebruary 14, 2024
June 1, 2023
2.9 years
July 15, 2020
January 23, 2024
January 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Number of Platelet Transfusions Per Participant Issued During the AHCT Admission
up to 100 days from AHCT
Study Arms (1)
romiplostim
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adult patients ≥ 18 years old diagnosed with multiple myeloma (MM), any subtype of Hodgkin lymphoma (HL), or any subtype of non-Hodgkin lymphoma (NHL)
- For MM, the conditioning regimen used will be high-dose melphalan.°For HL and NHL, the conditioning will be one of the following high-dose regimens: BEAM, CBV, or TBC.
- Other conditioning regimens not listed above, or variations of the above conditioning regimens, may be allowed at the discretion of the principal investigator if the regimen is considered myeloablative.
- Adequate organ function is required, defined as follows:
- Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia.
- AST, ALT, and alkaline phosphatase \< 3 times the upper limit of normal.
- Creatinine clearance ≥ 40 ml/min (calculated by Cockcroft Gault)
- LVEF ≥ 45% by MUGA or resting echocardiogram
- Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted.
- Adequate performance status ECOG ≤ 2.
- Ability to provide written informed consent.
- Patients undergoing HDT-AHCT.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Amgencollaborator
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
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
Related Publications (1)
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.
PMID: 36409612DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael Scordo, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Scordo, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2020
First Posted
July 20, 2020
Study Start
July 14, 2020
Primary Completion
June 8, 2023
Study Completion
June 8, 2023
Last Updated
February 14, 2024
Results First Posted
February 14, 2024
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
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.