Clinical trial · Interventional
Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation
Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient cell mobilization for tandem transplants
Summary
Brief summary (as posted)
This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2\*10\^6 CD34+ cells/kg and the target is ≧4\*10\^6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of transplant will be assessed for a minimum of one year.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Multiple Myeloma (MM)
- description
- Participants with MM who were eligible for autologous peripheral blood stem cell transplantation.
- interventionNames
- Drug: plerixafor
Primary outcomes (2)
- measure
- Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg
- timeFrame
- Day 1 up to day 4
- description
- Number of participants achieving a target of ≥ 4\*10\^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Target was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.
- measure
- Participant Counts of Summarized Adverse Events (AE) During Treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of multiple myeloma (MM) * Eligible for autologous transplantation * Patients in first or second partial remission (PR) or complete remission (CR) * Patients who have received ≦2000 rads of prior radiation therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Recovered from all acute toxic effects of prior chemotherapy * White blood cells (WBC) \>3.0\*10\^9/l * Absolute polymorphonuclear leucocyte (PMN) count \>1.5\*10\^9/l * Platelet (PLT) count \> 150\*10\^9/l * Serum creatinine ≦2.2 mg/dl * Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin \<2 x upper limit of normal (ULN) * Negative for HIV * Signed informed consent * Patients of childbearing potential agree to use an approved form of contraception Exclusion Criteria: * Patient received 2 or more alkylating agents, such as VBMCP (a combination of Vincristine, BCNU (Bis-Chloronitrosourea), Melphalan, Cyclophosphamide, and Prednisone) * Patient received a total dose of ≧200 mg of prior melphalan * A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications * Patient has failed previous collections or collection attempts * A residual acute medical condition resulting from prior chemotherapy * Brain metastases or carcinomatous meningitis * Acute infection * Fever (temperature \>38 °C / 100.4 °F) * Hypercalcemia (\>1mg/dl above ULN) * Positive pregnancy test in female patients * Lactating females * Patients of childbearing potential unwilling to implement adequate birth control * Patients whose actual body weight exceeds 175% of their ideal body weight * History of ventricular arrhythmias * Patient received thalidomide within 10 days prior to receiving the first dose of plerixafor * Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase
References
Publications (2)
- RESULTFlomenberg N, Comenzo R, Badel K, Calandra G. Single agent AMD3100 mobilization of peripheral blood progenitor cells for autologous transplantation in patients with multiple myeloma (MM) [abstract]. Blood. Nov 16 2006;108(11 Pt 1):965a.
- RESULTFlomenberg N, Comenzo RL, Badel K, Calandra G. Plerixafor (Mozobil) alone to mobilize hematopoietic stem cells from multiple myeloma patients for autologous transplantation. Biol Blood Marrow Transplant. 2010 May;16(5):695-700. doi: 10.1016/j.bbmt.2009.12.538. Epub 2010 Jan 11. PMID 20067838