Long-term Observational Follow-up Study of a Multicenter, Randomized, Double-blind, Placebo-controlled, Comparative Trial of AMD3100 (240 µg/kg) plus G-CSF (10 µg/kg) Versus G-CSF (10 µg/kg) plus Placebo to Mobilize and Collect = 6×106 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005320-16-DE

Enrollment

Registered

2007-02-01

Start date

2007-09-25

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Survival of multiple myeloma patients following autologous transplant in study AMD3100-3102. MedDRA version: 8.1 Level: LLT Classification code 10028228 Term: Multiple myeloma

Interventions

Product Name: AMD3100 Product Code: AMD3100 Pharmaceutical Form: Solution for injection INN or Proposed INN: plerixafor CAS Number: 110078-46-1 Current Sponsor code: AMD3100 Concentration unit: mg/ml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who received at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this long-term observational study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102.;Secondary Objective: N/A;Primary end point(s): Progression-free survival and overall survival will be assessed for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (phase 3). Patients will fall into 1 of 2 categories: patients who underwent transplant in protocol AMD3100-3102 and patients who did not undergo transplant in protocol AMD3100-3102. The schedule of follow-up contact will be based on whether or not a patient received a transplant. • For those patients who underwent transplant in protocol AMD3100-3102 (including those who withdrew or were lost to follow-up), follow-up contact will occur every 6 months (± 3 months) beginning 18-months post-transplant or at study entry (i.e., signed informed consent), whichever is applicable, for a total follow-up period of 5 years following the first dose of study treatment. • For those patients who did not undergo transplant in protocol AMD3100-3102, the first follow-up contact will occur at the time of study entry (i.e., signed informed consent); thereafter follow-up contact will occur every 6 months (± 3 months) for a total follow-up period of 5 years following the first dose of study treatment. At study entry, patient history will be assessed. The following outcomes will be recorded by the Investigator at the time of study entry and at each follow-up contact: • Death: Yes or No. If Yes, the date of death and whether or not it was disease-related will be recorded • Disease progression/relapse: Yes or No. If Yes, the specific event and date of disease/progression relapse will be recorded. In addition, whether or not the patient re	—

Measure

Time frame

Main Objective: The objective of this long-term observational study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102.;Secondary Objective: N/A;Primary end point(s): Progression-free survival and overall survival will be assessed for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (phase 3). Patients will fall into 1 of 2 categories: patients who underwent transplant in protocol AMD3100-3102 and patients who did not undergo transplant in protocol AMD3100-3102. The schedule of follow-up contact will be based on whether or not a patient received a transplant. • For those patients who underwent transplant in protocol AMD3100-3102 (including those who withdrew or were lost to follow-up), follow-up contact will occur every 6 months (± 3 months) beginning 18-months post-transplant or at study entry (i.e., signed informed consent), whichever is applicable, for a total follow-up period of 5 years following the first dose of study treatment. • For those patients who did not undergo transplant in protocol AMD3100-3102, the first follow-up contact will occur at the time of study entry (i.e., signed informed consent); thereafter follow-up contact will occur every 6 months (± 3 months) for a total follow-up period of 5 years following the first dose of study treatment. At study entry, patient history will be assessed. The following outcomes will be recorded by the Investigator at the time of study entry and at each follow-up contact: • Death: Yes or No. If Yes, the date of death and whether or not it was disease-related will be recorded • Disease progression/relapse: Yes or No. If Yes, the specific event and date of disease/progression relapse will be recorded. In addition, whether or not the patient re

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026