Phase 2
Completed N=21
Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
Multiple Myeloma · Non-Hodgkin's Lymphoma · Hodgkins Disease
Source: ClinicalTrials.gov NCT00901225 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF. — 15 participants
Summary
Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008, Plerixafor received approval from the Food and Drug administration for use in combination with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is not designed to support approval of a new indication or change in the advertising for Plerixafor. The route of administration and dosage level are identical to that which is listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins Lymphoma, there is no known or theoretic increased risk of the use of this drug in this patient population.
The study hypothesis for this study is that patients with a circulating CD34+ count or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF. |
15 | — |
| SECONDARY Number of Participants Experiencing a Grade III/IV Toxicity |
— | — |
| SECONDARY Number of Subjects Experiencing Graft Failure |
— | — |
| SECONDARY Days to Absolute Neutrophil Count >500 |
11 | — |
| SECONDARY Number of Subjects Experiencing Durability of Engraftment |
20 | — |
| SECONDARY Platelet Engraftment |
19 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 75 years.
- Diagnosis of NHL, HD or MM
- Eligible for autologous transplantation
- CD34+ cell count 1.0 X 10(9)/l prior to first dose of G-CSF
- PLT count > 75 X 10(9)/l prior to first dose of G-CSF
- Serum creatinine < or equal to 2.5 mg/dl
- SGOT, SGPT and total bilirubin < 2 X upper limit of normal (ULN) prior to the first dose of G-CSF
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation as determined by standard institutional practice
- Signed informed consent
- Patients of childbearing potential agree to use an approved form of contraception
Exclusion Criteria
- A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications
- Failed previous stem cell collection or collection attempts
- A residual acute medical condition resulting from prior chemotherapy
- Active brain metastases or carcinomatous meningitis
- Active infection requiring antibiotic treatment (excluding controlled catheter-related bacteremia)
- Received prior radio-immunotherapy with Zevalin or Bexxar
- Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF
- Positive pregnancy test in female patients
- Lactating females
- Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol
Data sourced from ClinicalTrials.gov (NCT00901225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.