Clinical trial · Observational
Long-Term Follow Up Study for AMD3100 Patients
Long-Term Observational Follow-Up Study of a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 (240 MCG/KG) Plus G-CSF (10 MCG/KG) Versus G-CSF (10 MCG/KG) Plus Placebo to Mobilize and Collect >/= 6 x 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)
Objectives: The objective of this long-term observational study is to assess progression-free survival and overall survival for a period of five years following the first dose of study treatment (placebo or plerixafor \[AMD3100\]) in protocol AMD3100-3102. Patients that received at least 1 dose of study treatment (placebo or plerixafor) in the multicenter, randomized, double-blind, placebo-controlled AMD3100-3102 study, which was designed to evaluate plerixafor plus granulocyte colony stimulating factor (G-CSF) versus placebo plus G-CSF to mobilize hematopoietic stem cells for autologous transplantation of Multiple Myeloma (MM) patients are eligible.
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 |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Telephone Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1: G + Placebo
- description
- G-CSF plus Placebo Arm (G + Placebo)
- interventionNames
- Other: Telephone Questionnaire
- label
- Group 2: G + AMD3100
- description
- G-CSF plus AMD3100 Arm (G + AMD3100)
- interventionNames
- Other: Telephone Questionnaire
Primary outcomes (2)
- measure
- Progression-free Survival at 5 Years
- timeFrame
- 5 Years
- description
- Progression-free survival defined as number of participants without disease progression at five years following the first dose of study treatment (placebo or plerixafor \[AMD3100\]).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: * 1\) All patients who received the study drug (placebo or plerixafor) on protocol AMD3100-3102 (2004-0982) Exclusion Criteria: None
References
Publications (0)
Data not yet available