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

  • STATUS
    Recruiting
  • End date
    Jul 30, 2023
  • participants needed
    63
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 30 September 2021
platelet count
cancer
hematologic malignancy
lymphoma
multiple myeloma
hodgkin's disease
melphalan
cell transplantation
transplant conditioning
chemotherapy regimen

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.

Details
Condition HDT-AHCT, Lymphoproliferative Disorder, hodgkin's lymphoma, Non-Hodgkin's Lymphoma, hodgkins lymphoma, multiple myeloma (mm), hodgkin, hodgkin's lymphomas, Lymphoma, hodgkin lymphomas, Multiple Myeloma, non-hodgkin's lymphoma (nhl), Hodgkin's Disease, Lymphoproliferative disorders
Treatment romiplostim
Clinical Study IdentifierNCT04478123
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on30 September 2021

Eligibility

Yes No Not Sure

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)
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

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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