A Phase 2 interventional study of Plerixafor in Myeloma and Lymphoma, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-09-29.
Sponsored by Emory University · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 45 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Drug: Plerixafor
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.
Also known as: Mozobil, AMD3100
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
Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg
Time frame: Within the first 4 days following the first dose of Plerixafor
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
| Milestone | Plerixafor + Chemo and G-CSF |
|---|---|
| Started | 45 |
| Completed | 45 |
| Not completed | 0 |
| participants | Multiple Myeloma | Lymphoma |
|---|---|---|
| Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis | 9 | 17 |
| days | Multiple Myeloma | Lymphoma |
|---|---|---|
| Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500) | 12.4 ± 1.62 | 12.105 ± 1.63 |
| participants | Multiple Myeloma | Lymphoma |
|---|---|---|
| Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg | 10 | 23 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Plerixafor + Chemo and G-CSF | — | 0/45 (0%) | 29/45 (64.4%) |
| Event | Plerixafor + Chemo and G-CSF |
|---|---|
| Thrombocytopenia Grade 1/2Blood and lymphatic system disorders | 26/45 |
| Thrombocytopenia Over Grade 2Blood and lymphatic system disorders | 17/45 |
| NauseaGastrointestinal disorders | 13/45 |
| Bone PainMusculoskeletal and connective tissue disorders | 12/45 |
| DiarrheaGastrointestinal disorders | 12/45 |
| FatigueGeneral disorders | 11/45 |
| HypokalemiaBlood and lymphatic system disorders | 8/45 |
| LightheadednessGeneral disorders | 7/45 |
| HeadacheGeneral disorders | 6/45 |
| AnemiaBlood and lymphatic system disorders | 1/45 |
| Age, Continuous(years) | Plerixafor + Chemo and G-CSF |
|---|---|
| Multiple Myeloma (MM), n = 17 | 58 (33 to 72) |
| Lymphoma, n = 28 | 56 (38 to 73) |
| Sex: Female, Male(Participants) | Plerixafor + Chemo and G-CSF |
|---|---|
| Female | 15 |
| Male | 30 |
| Race (NIH/OMB)(Participants) | Plerixafor + Chemo and G-CSF |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 14 |
| White | 29 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Plerixafor + Chemo and G-CSF |
|---|---|
| United States | 45 |
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Emory University