Phase 2
Completed N=40
Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients
Lymphoma, Non-Hodgkin · Multiple Myeloma
Source: ClinicalTrials.gov NCT00322387 ↗
Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Jul 2010
Primary outcomePrimary: Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant — 7; 6; 1; 12 participants
Summary
Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant |
7; 6; 1; 12; 9; 1 | — |
| SECONDARY Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL |
2.2; 1.5; 1.2; 1.8; 6.5; 24.0 | — |
| SECONDARY Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant |
6; 4; 0; 14; 9; 1 | — |
Eligibility Criteria
Inclusion Criteria (Abbreviated List):
- MM in first partial response/complete response, first relapse, or second partial/complete response
- NHL in first or second partial or complete remission
- NHL patients who do not have bone marrow involvement and 3.0 x 10^9/L
- Absolute neutrophil count >1.5 x 10^9/L
- Platelet count >100 x 10^9/L
Exclusion Criteria (Abbreviated List):
- Brain metastases or carcinomatous meningitis
- Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)]
- Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias
- Acute Infection
Data sourced from ClinicalTrials.gov (NCT00322387). 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.