Phase 3
Completed N=302
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
Source: ClinicalTrials.gov NCT00103662 ↗Enrolled (actual)
302
Serious AEs
3.4%
Results posted
Sep 2010
Primary outcomePrimary: Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis. — 0.716; 0.344; 0.284; 0.656 proportion of participants
Summary
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis. |
0.716; 0.344; 0.284; 0.656 | — |
| SECONDARY Number of Participants With Adverse Events |
140; 140; 95; 67; 1; 2 | — |
| SECONDARY Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis. |
0.757; 0.513; 0.243; 0.487 | — |
| SECONDARY Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis. |
0.953; 0.883; 0.047; 0.117 | — |
| SECONDARY Median Number of Days to ≥6*10^6 CD34+ Cells/kg |
1.0; 4.0 | — |
| SECONDARY Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment |
11.0; 11.0 | — |
| SECONDARY Median Number of Days to Platelet (PLT) Engraftment |
18.0; 18.0 | — |
| SECONDARY Graft Durability at 100 Days Post Transplantation |
0.986; 0.978; 0.014; 0.022 | — |
| SECONDARY Graft Durability at 6 Months Post Transplantation |
0.985; 0.984; 0.015; 0.016 | — |
| SECONDARY Graft Durability at 12 Months Post Transplantation |
0.992; 0.992; 0.008; 0.008 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of multiple myeloma in first or second complete or partial remission
- >= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)
- Recovered from all acute toxic effects of prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White Blood Cell count (WBC) > 2.5*10^9/L
- Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L
- Platelet (PLT) > 100*10^9/L
- Serum creatinine <=2.2 mg/dL
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
- Negative for HIV
Exclusion Criteria):
- Failed previous stem cell collection
- Previous stem cell transplantation
- Brain metastases or myelomatous meningitis
- Radiation to ≥ 50% of the pelvis
- Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
- Received bone-seeking radionuclides (e.g. holmium)
- A residual acute medical condition resulting from prior chemotherapy
Data sourced from ClinicalTrials.gov (NCT00103662). 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.