AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone

NCT00395967 | Terminated Phase 2 Results

• 1 other identifier: AMD3100-2109
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\*10\^6 CD34+ cells/kg within 3 apheresis days. Patients with NHL and MM were eligible to enter the study if they had undergone cyto-reductive chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion criteria. The purpose of this protocol was to determine whether plerixafor in combination with Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low after treatment with G-CSF alone, whether it was safe, and whether transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin's

Keywords

Non-Hodgkin's Lymphoma; Multiple Myeloma; stem cell mobilization; autologous transplantation; AMD3100

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days

  The number of patients with a circulating CD34+ count \>= 5 and \< 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2\*10\^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.

  approximately days 6-9

Secondary Outcomes (5)

• Overall Participants Counts of Adverse Events

  up to 13 months

• The Fold Increase in Peripheral Blood CD34+ Cells Following the First Dose of Plerixafor

  Days 5-6

• Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment

  2 months

• Number of Days to Platelet (PLT) Engraftment

  2 months

• Graft Durability at 12 Months After Transplantation

  13 months

Study Arms (1)

All Patients

EXPERIMENTAL

Patients who were predicted to be unable to mobilize a minimum number of cells (≥2\*10\^6 CD34+ cells/kg) in 3 apheresis days when given granulocyte colony-stimulating factor (G-CSF) alone and who were eligible for autologous peripheral blood stem cell transplantation.

Drug: G-CSF plus plerixafor

Interventions

G-CSF plus plerixafor DRUG

Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.

Also known as: Mozobil, AMD3100

All Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM)
• Eligible for autologous transplantation
• \<=3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
• \>4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
• Total dose of melphalan ≦200 mg
• Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
• White blood cell (WBC) count \>3.0\*10\^9/L prior to first dose of G-CSF
• Absolute polymorphonuclear leukocyte (PMN) count \>1.5\*10\^9/L prior to first dose of G-CSF
• Platelet (PLT) count \>100\*10\^9/L prior to first dose of granulocyte colony-stimulating factor (G-CSF)
• Serum creatinine ≥2.2 mg/dL
• SGOT, SGPT and total bilirubin \<2 times upper limit of normal (ULN)
• Negative for HIV
• CD34+ cell count between 5 and 19 CD34+ cells/ml after 5 days of mobilization with G-CSF alone

You may not qualify if:

• A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications
• Failed previous stem cell collection or collection attempts
• A residual acute medical condition resulting from prior chemotherapy
• Active brain metastases or carcinomatous meningitis
• Active infection requiring antibiotic treatment
• Received prior radio-immunotherapy with Zevalin or Bexxar
• Received bone-seeking radionuclides (e.g., holmium)
• Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF
• History of ventricular arrhythmias, including electrocardiogram (ECG)-documented premature ventricular contractions (PVCs), during the last 3 years
• Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase
• Had an apheresis yield \>1.3\*10\^6 CD34+ cells/kg on Day 5 (Applicable only to patients who, after 5 days of G-CSF mobilization, have peripheral blood (PB) CD34+ count of 8-19 cells/µl inclusive).

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (1)

Duke University Medical Center - Adult BMT Program

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin

Interventions

Granulocyte Colony-Stimulating Factor; plerixafor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Limited enrollment due to early termination of the study.

Results Point of Contact

• Title: Genzyme Medical Information
• Organization: Genzyme Corporation

800-745-4447

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 6, 2006
• Study Start: April 1, 2005
• Primary Completion: July 1, 2005
• Study Completion: August 1, 2006
• Last Updated: May 1, 2015
• Results First Posted: August 13, 2010

Record last verified: 2015-04

Locations

US (1)