Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization

NCT01037517 | Completed Phase 2

• 1 other identifier: CCM-002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection. OBJECTIVES To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will:

• increase the number of patients successfully collected in one day
• increase the number of patients successfully mobilized on first collection attempt
• is cost neutral within a Canadian setting

Conditions

Multiple Myeloma; Lymphoma

Keywords

Myeloma; Multiple Myeloma or Lymphoma Patients undergoing; mobilization for the purpose of autologous stem cell collection

Outcome Measures

Primary Outcomes (1)

• To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%.

  within 1-2 days after commencing therapy

Secondary Outcomes (4)

• To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected on first mobilization attempt rather than requiring a second mobilization.

  After therapy

• To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor

  After therapy

• To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor

  After therapy

• To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization

  After therapy

Study Arms (2)

Successful Mobilizers

ACTIVE COMPARATOR

Successful Mobilizers are defined as having a peripheral blood CD34 \> 10X106/L.

Other: Observation: Nonintervention

Poor Mobilizers

EXPERIMENTAL

Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood \[CD34\] ≤ 10 X106/L

Drug: Plerixafor

Interventions

Plerixafor DRUG

Plerixafor will be administered at 23:00 of Day -1 to experimental subjects at a dose of 240 mcg/kg subcutaneously, and possibly repeated the following day

Also known as: Mozobil®

Poor Mobilizers

Observation: Nonintervention OTHER

Nonintervention group, no drug will be given, observation only

Successful Mobilizers

Eligibility Criteria

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

You may qualify if:

• Participants must be 18 years of age or older
• Patients must be able to provide written consent
• Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT
• Females of child bearing age will be asked to use an approved form of contraception

You may not qualify if:

• Patients who are pregnant or breastfeeding
• Patients whose creatinine ≥ 250 μM
• Serum AST, ALT or total bilirubin \>5X upper limit of normal
• Acute infection

Sponsors & Collaborators

• CancerCare Manitoba: lead

Study Sites (1)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Related Links

• Official CancerCare Manitoba Website

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma; Neoplasms, Plasma Cell

Interventions

plerixafor

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; Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematologist/Oncologist

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 23, 2009
• Study Start: January 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

CA (1)