Long-Term Follow Up Study for AMD3100 Patients

NCT00476294 | Completed DMC

• 1 other identifier: 2006-0665
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Myeloma

Keywords

Multiple Myeloma; Disease-Free Survival; AMD3100; G-CSF; Autologous Transplantation

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival at 5 Years

  Progression-free survival defined as number of participants without disease progression at five years following the first dose of study treatment (placebo or plerixafor \[AMD3100\]).

  5 Years

• Overall survival at 5 Years

  Overall survival defined as number of participants alive after a period of five years following the first dose of study treatment (placebo or plerixafor \[AMD3100\]).

  5 years

Study Arms (2)

Group 1: G + Placebo

G-CSF plus Placebo Arm (G + Placebo)

Other: Telephone Questionnaire

Group 2: G + AMD3100

G-CSF plus AMD3100 Arm (G + AMD3100)

Other: Telephone Questionnaire

Interventions

Telephone Questionnaire OTHER

Follow-Up Telephone Calls Every 6 Months for 5 Years.

Also known as: Survey

Group 1: G + Placebo; Group 2: G + AMD3100

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who were randomized in a double-blind study and received a stem cell transplant after treatment with AMD3100 and G-CSF OR treatment with Placebo and G-CSF.

You may qualify if:

• \) All patients who received the study drug (placebo or plerixafor) on protocol AMD3100-3102 (2004-0982)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• AnorMED: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Multiple Myeloma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Chitra M. Hosing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: October 1, 2006
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

US (1)