Clinical trial · Interventional
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Granulocyte colony-stimulating factor plus placebo | Drug | — | UNRESOLVED |
| Granulocyte colony-stimulating factor plus plerixafor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- G-CSF plus plerixafor
- interventionNames
- Drug: Granulocyte colony-stimulating factor plus plerixafor
- type
- PLACEBO_COMPARATOR
- label
- G-CSF plus placebo
- interventionNames
- Drug: Granulocyte colony-stimulating factor plus placebo
Primary outcomes (1)
- measure
- Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
- timeFrame
- up to Day 6
- description
- Proportion of participants achieving a target of ≥ 6\*10\^6 CD34+ cells/kg in 2 or fewer days of apheresis. Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 78 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTDiPersio JF, Stadtmauer EA, Nademanee A, Micallef IN, Stiff PJ, Kaufman JL, Maziarz RT, Hosing C, Fruehauf S, Horwitz M, Cooper D, Bridger G, Calandra G; 3102 Investigators. Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood. 2009 Jun 4;113(23):5720-6. doi: 10.1182/blood-2008-08-174946. Epub 2009 Apr 10. PMID 19363221