HDT-AHCT, Hodgkin Lymphoma, Multiple Myeloma, Non-Hodgkin Lymphoma
Conditions
Keywords
High-Dose Therapy, Autologous Hematopoietic Cell Transplantation, Romiplostim, Thrombocytopenia, 20-180
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.
Interventions
DRUGRomiplostim
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.
Sponsors
Amgen
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single-center, open-label, pilot study of romiplostim for patients undergoing HDT-AHCT.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Post HDT-AHCT Requiring Transfusions or Grade 4 CTCAE Thrombocytopenia | up to 42 days | Common Terminology Criteria for Adverse Events (CTCAE) Version 5. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Platelet Transfusions Per Participant Issued During the AHCT Admission | up to 100 days from AHCT |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | NE | 1 |
| Overall Study | Pt withdrawal or refusal before begin prot txt | 2 |
Baseline characteristics
| Characteristic | Romiplostim |
|---|---|
| Age, Continuous | 63 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment United States | 62 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 62 |
| other Total, other adverse events | 62 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
Number of Days Post HDT-AHCT Requiring Transfusions or Grade 4 CTCAE Thrombocytopenia
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
Time frame: up to 42 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Romiplostim | Number of Days Post HDT-AHCT Requiring Transfusions or Grade 4 CTCAE Thrombocytopenia | 6 days |
Secondary
Number of Platelet Transfusions Per Participant Issued During the AHCT Admission
Time frame: up to 100 days from AHCT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Romiplostim | Number of Platelet Transfusions Per Participant Issued During the AHCT Admission | 2 number of platelet transfusions per pt |