Non-Hodgkin's Lymphoma, Plasma Cell Myeloma
Conditions
Brief summary
This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.
Detailed description
PRIMARY OBJECTIVE: I. To demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (G-CSF) + plerixafor-mobilized autologous stem cell transplant in patients receiving versus not receiving post-transplant growth factor support. SECONDARY OBJECTIVE: I. To compare days to absolute neutrophil count (ANC) \> 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support. EXPLORATORY OBJECTIVE: I. To evaluate immunological recovery (lymphocyte number including CD 3/4 and CD3/8 T cell subsets) at day + 60 in patients receiving versus not receiving post-transplant growth factor support.
Interventions
PROCEDUREHematopoietic Cell Transplantation
Undergo auto HSCT
DRUGTbo-filgrastim
Given subcutaneously
OTHERLaboratory Biomarker Analysis
Correlative Studies
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing autologous stem cell transplant for one of the following diagnoses: * Multiple myeloma * Non-Hodgkin lymphoma * Karnofsky performance status of \>= 70% * Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for Patient Criteria for Autologous HSCT * Left ventricular ejection fraction (LVEF) of ≥ 40% * Adjusted Carbon monoxide diffusing capability (DLCO) \> 45% of predicted corrected for hemoglobin * Serum bilirubin \< 1.8 * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 X upper limit of normal * Serum creatinine =\< 2.0 mg/dl and/or creatinine clearance of \> 40 ml/min (excludes multiple myeloma patients receiving high dose melphalan conditioning) * Willingness to use contraception if childbearing potential * Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process * Life expectancy of \> 12 months (exclusive of the disease for which the auto HSCT is being performed) * Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines * Collection of an adequate number of CD34+ stem cells, i.e. \>= 4-6 x 10\^6/kg from apheresis
Exclusion criteria
* Uncontrolled human immunodeficiency virus (HIV) * Uncontrolled bacterial infection * Active central nervous system (CNS) disease * Pregnancy or lactation * Evidence of another malignancy, exclusive of a skin cancer that requires only local treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days to Discharge | Up to 60 days | Will compare days to discharge readiness between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Days Post Auto HSCT to Platelet Engraftment | Up to 60 days | Will be defined as date platelet greater than or equal to 20 x 10\^9 /L without a platelet transfusion within the last 7 days. |
| Percentage of Participants With Engraftment Syndrome | Up to 60 days | Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test |
| Median Number of Febrile Days During the Auto HSCT Inpatient Stay | Up to 60 days | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests |
| Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay | Up to 60 days | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests. |
| Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment | Up to 60 days | Will be defined as absolute neutrophil count \> 500 x 10\^9/L x 3 days. Day of engraftment is the first of the 3 days of absolute neutrophil count \> 500 x 10\^9/L. |
| Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay | Up to 60 days | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests. |
| Percentage of Participants Receiving Corticosteroids | Up to 60 days | will be presented as percentage of number of subjects who had the treatment |
| Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT | Up to 60 days | will be presented as percentage of number of subjects who had the treatment |
| Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay | Up to 60 days | Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group I (Auto HSCT Tbo-filgrastim) Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies | 38 |
| Group II (Auto HSCT) Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies | 39 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 9 |
Baseline characteristics
| Characteristic | Group I (Auto HSCT Tbo-filgrastim) | Group II (Auto HSCT) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 19 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 20 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 37 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) White | 24 Participants | 27 Participants | 51 Participants |
| Sex: Female, Male Female | 12 Participants | 20 Participants | 32 Participants |
| Sex: Female, Male Male | 26 Participants | 19 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 37 | 9 / 39 |
| other Total, other adverse events | 37 / 37 | 39 / 39 |
| serious Total, serious adverse events | 6 / 37 | 10 / 39 |
Outcome results
Primary
Number of Days to Discharge
Will compare days to discharge readiness between the two groups.
Time frame: Up to 60 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Number of Days to Discharge | 11 days |
| Group II (auto HSCT) | Number of Days to Discharge | 15 days |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Median Days Post Auto HSCT to Platelet Engraftment
Will be defined as date platelet greater than or equal to 20 x 10\^9 /L without a platelet transfusion within the last 7 days.
Time frame: Up to 60 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Median Days Post Auto HSCT to Platelet Engraftment | 19 days |
| Group II (auto HSCT) | Median Days Post Auto HSCT to Platelet Engraftment | 19 days |
p-value: 0.578Wilcoxon (Mann-Whitney)
Secondary
Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment
Will be defined as absolute neutrophil count \> 500 x 10\^9/L x 3 days. Day of engraftment is the first of the 3 days of absolute neutrophil count \> 500 x 10\^9/L.
Time frame: Up to 60 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment | 11 days |
| Group II (auto HSCT) | Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment | 13 days |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Time frame: Up to 60 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay | 4 antibiotic inpatient days |
| Group II (auto HSCT) | Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay | 7 antibiotic inpatient days |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Time frame: Up to 60 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay | 2 days of inpatient febrile neutropenia |
| Group II (auto HSCT) | Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay | 4 days of inpatient febrile neutropenia |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay
Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant
Time frame: Up to 60 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay | 0 documented inpatient stay infections |
| Group II (auto HSCT) | Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay | 0 documented inpatient stay infections |
p-value: 0.936Wilcoxon (Mann-Whitney)
Secondary
Median Number of Febrile Days During the Auto HSCT Inpatient Stay
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests
Time frame: Up to 60 days
Population: This data set was not reported. Upon further inspection into the subject data, there were few infections and most of the fevers were from neutropenia. No qualifying infections or fevers were reported to fit this specific criteria. Therefore, the numbers are presented as zero for both arms. Specific adverse event reporting data can be found in more detail in the AE/SAE section of this record.
Secondary
Percentage of Participants Receiving Corticosteroids
will be presented as percentage of number of subjects who had the treatment
Time frame: Up to 60 days
Population: Protocol initially stated that median number of days on corticosteroids will be summarized by treatment arm and compared using Wilcoxon rank sum tests up to 60 days; data reported as Steroids initiated percentage
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Percentage of Participants Receiving Corticosteroids | 31.4 percentage of patients |
| Group II (auto HSCT) | Percentage of Participants Receiving Corticosteroids | 51.4 percentage of patients |
p-value: 0.089Chi-squared
Secondary
Percentage of Participants With Engraftment Syndrome
Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test
Time frame: Up to 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Percentage of Participants With Engraftment Syndrome | 48.6 percentage of participants |
| Group II (auto HSCT) | Percentage of Participants With Engraftment Syndrome | 60 percentage of participants |
p-value: 0.337Chi-squared
Secondary
Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT
will be presented as percentage of number of subjects who had the treatment
Time frame: Up to 60 days
Population: Protocol initially stated that number of post discharge granulocyte colony-stimulating factor administrations through day +60 post auto HSCT will be summarized by treatment arm and compared using Wilcoxon rank sum tests up to 60 days; data available is reported as reported as number with G-CSF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT | 5.7 Percentage of Participants |
| Group II (auto HSCT) | Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT | 8.6 Percentage of Participants |
p-value: 0.645Chi-squared