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

NCT00322387 | Completed Phase 2 Results DMC

• 1 other identifier: AMD3100-2104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Lymphoma, Non-Hodgkin; Multiple Myeloma

Keywords

Non-Hodgkin's Lymphoma; Multiple Myeloma; Stem cell mobilization

Outcome Measures

Primary Outcomes (1)

• Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant

  Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.

  13 months

Secondary Outcomes (2)

• Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL

  Days 4-5 (first dose of plerixafor to apheresis)

• 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

  2 months

Study Arms (4)

Plerixafor PM

EXPERIMENTAL

Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Called 'Cohort A' in protocol, study report and publications.

Drug: G-CSF and plerixafor

Plerixafor AM

EXPERIMENTAL

Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days. Called 'Cohort B' in protocol, study report and publications.

Drug: G-CSF and plerixafor

Low CD34+ Count/ Plerixafor PM

EXPERIMENTAL

Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days. Called 'Cohort C' in protocol, study report and publications.

Drug: G-CSF and plerixafor

Plerixafor After Chemo

EXPERIMENTAL

This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms. Called 'Investigational Cohort' in protocol, study report and publications.

Drug: G-CSF and plerixafor

Interventions

G-CSF and plerixafor DRUG

G-CSF and plerixafor were administered as described in the treatment arms.

Also known as: Mozobil, AMD3100

Low CD34+ Count/ Plerixafor PM; Plerixafor AM; Plerixafor After Chemo; Plerixafor PM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 10% for follicular involvement
• MM patients who have stable disease with \< 40% bone marrow involvement
• No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• White blood cell count (WBC) \>3.0 x 10\^9/L
• Absolute neutrophil count \>1.5 x 10\^9/L
• Platelet count \>100 x 10\^9/L

You may not qualify if:

• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (5)

City of Hope National Medical Center

Duarte, California, United States

Location

Indiana Blood and Marrow Transplantation

Beech Grove, Indiana, United States

Location

University of Rochester Medical Center

Rochester, New York, United States

Location

Oregon Health and Science University

Portland, Oregon, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Location

Related Publications (1)

• Dugan MJ, Maziarz RT, Bensinger WI, Nademanee A, Liesveld J, Badel K, Dehner C, Gibney C, Bridger G, Calandra G. Safety and preliminary efficacy of plerixafor (Mozobil) in combination with chemotherapy and G-CSF: an open-label, multicenter, exploratory trial in patients with multiple myeloma and non-Hodgkin's lymphoma undergoing stem cell mobilization. Bone Marrow Transplant. 2010 Jan;45(1):39-47. doi: 10.1038/bmt.2009.119. Epub 2009 Jun 1.

  PMID: 19483760 RESULT

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Multiple Myeloma

Interventions

Granulocyte Colony-Stimulating Factor; plerixafor

Condition Hierarchy (Ancestors)

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

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

The number and complexity of the cohorts make generalizations regarding the data problematic. Each cohort was small, and mobilizing and high-dose conditioning regimens varied across sites. AEs may include residual effects of chemotherapy.

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: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 4, 2006
• First Posted: May 5, 2006
• Study Start: April 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: March 13, 2014
• Results First Posted: July 14, 2010

Record last verified: 2014-02

Locations

US (5)