Clinical trial NCT04478123: Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer
Official title: An Open-Label, Pilot Study of Romiplostim for Conditioning Regimen-Related Thrombocytopenia After High-Dose Therapy and Autologous Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
HDT-AHCT
Keywords: High-Dose Therapy
Autologous Hematopoietic Cell Transplantation
Romiplostim
Thrombocytopenia
20-180
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2020-07-20
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-center, open-label, pilot study of romiplostim for patients undergoing HDT-AHCT.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Days Post HDT-AHCT Requiring Transfusions or Grade 4 CTCAE Thrombocytopenia
timeFrame: up to 42 days
Secondary outcomes:
measure: Number of Platelet Transfusions Per Participant Issued During the AHCT Admission
timeFrame: up to 100 days from AHCT
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael Scordo, MD
role: PRINCIPAL_INVESTIGATOR
References: