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Phase 2 N=40 Treatment

Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients

Lymphoma, Non-Hodgkin · Multiple Myeloma

Bottom Line

View on ClinicalTrials.gov: NCT00322387 ↗
Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Jul 2010
Primary outcome: Primary: Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant — 7; 6; 1; 12 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
G-CSF and plerixafor (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Genzyme, a Sanofi Company
Primary completion
Jul 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant		 7; 6; 1; 12; 9; 1 —
SECONDARY
Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL		 2.2; 1.5; 1.2; 1.8; 6.5; 24.0 —
SECONDARY
Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant		 6; 4; 0; 14; 9; 1 —

Summary

Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

Eligibility Criteria

Inclusion Criteria (Abbreviated List):

  • MM in first partial response/complete response, first relapse, or second partial/complete response
  • NHL in first or second partial or complete remission
  • NHL patients who do not have bone marrow involvement and 3.0 x 10^9/L
  • Absolute neutrophil count >1.5 x 10^9/L
  • Platelet count >100 x 10^9/L

Exclusion Criteria (Abbreviated List):

  • Brain metastases or carcinomatous meningitis
  • Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)]
  • Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias
  • Acute Infection
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00322387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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