Long-Term Follow-up Study for Multiple Myeloma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3102 Study (NCT00103662).

Genzyme

Status: Completed

Conditions: Multiple Myeloma; Autologous Transplantation

Treatments: Drug: plerixafor; Drug: granulocyte colony-stimulating factor (G-CSF); Drug: Placebo

Study type: Observational

Funder types: Industry

Identifiers

NCT00741780

AMD31003102LTF

Details and patient eligibility

About

This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3102 protocol (NCT00103662).

Full description

This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled study to evaluate AMD3100 plus granulocyte colony stimulating factor (GCSF) versus G-CSF plus placebo to mobilize and transplant Multiple Myeloma (MM) patients (protocol AMD31003102LTF [NCT00103662]). The objective of this 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 (NCT00103662).

Enrollment: 164 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who received a dose of study treatment (plerixafor or placebo) in protocol AMD3100-3102 (NCT00103662)

Exclusion criteria

• No Exclusion Criteria

Trial design

164 participants in 2 patient groups

G-CSF plus plerixafor

Description:

Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received plerixafor prior to undergoing apheresis.

Treatment:

Drug: granulocyte colony-stimulating factor (G-CSF)

Drug: plerixafor

G-CSF plus placebo

Description:

Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received placebo prior to undergoing apheresis.

Treatment:

Drug: Placebo

Drug: granulocyte colony-stimulating factor (G-CSF)