Lymphoma, Myeloma
Conditions
Keywords
Myeloma, Lymphoma, Stem cell transplantation
Brief summary
The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor. The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
Interventions
DRUGPlerixafor
240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
Sponsors
Genzyme, a Sanofi Company
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-70 years 2. Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Up to 3 prior treatment regimens 5. Meet all eligibility requirements for autologous transplant 6. Adequate marrow function defined as white blood cells (WBC) \>3,000; ANC \>1,500/mm3; platelets \>75,000/mm3 7. Adequate renal function defined as creatinine clearance \> 30 mL/min by Cockcroft-Gault 8. Adequate liver function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin \< 2 times upper limit of normal 9. Able to provide informed consent 10. Women not pregnant and agree to use contraception
Exclusion criteria
1. High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease) 2. Brain metastases or carcinomatous meningitis 3. Previous treatment with high dose chemotherapy and autologous transplant 4. Previous attempt to collect B-hematopoietic progenitor cells (HPCs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors 5. Acute infection or unexplained fever \>38°C 6. Weight \> 175% of ideal body weight as defined by the Devine equation 7. Experimental therapy within 4 weeks 8. Cytokine administration in the previous 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis | Within the first 4 days following the first dose of Plerixafor |
| Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg | Within the first 4 days following the first dose of Plerixafor |
Secondary
| Measure | Time frame |
|---|---|
| Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500) | Within the first 4 days following the first dose of Plerixafor |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Plerixafor + Chemo and G-CSF Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Plerixafor + Chemo and G-CSF |
|---|---|
| Age, Continuous Lymphoma, n = 28 | 56 years |
| Age, Continuous Multiple Myeloma (MM), n = 17 | 58 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 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 | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 29 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg
Time frame: Within the first 4 days following the first dose of Plerixafor
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multiple Myeloma | Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg | 10 participants |
| Lymphoma | Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg | 23 participants |
Primary
Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis
Time frame: Within the first 4 days following the first dose of Plerixafor
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multiple Myeloma | Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis | 9 participants |
| Lymphoma | Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis | 17 participants |
Secondary
Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)
Time frame: Within the first 4 days following the first dose of Plerixafor
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multiple Myeloma | Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500) | 12.4 days | Standard Deviation 1.62 |
| Lymphoma | Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500) | 12.105 days | Standard Deviation 1.63 |