Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer
Condition: Multiple Myeloma; Hodgkin Lymphoma; Non-Hodgkin Lymphoma; HDT-AHCT
MeSH terms: Lymphoma; Multiple Myeloma
Intervention: Romiplostim
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: A single-center, open-label, pilot study of romiplostim for patients undergoing HDT-AHCT.
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: High-Dose Therapy; Autologous Hematopoietic Cell Transplantation; Romiplostim; Thrombocytopenia; 20-180

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.