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Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant

Primary Purpose

Multiple Myeloma, Non-Hodgkins Lymphoma, Hodgkins Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

G-CSF plus Plerixafor

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring NHL

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 to 75 years.
Diagnosis of NHL, HD or MM
Eligible for autologous transplantation
CD34+ cell count < 7 cells/ul after 5 days of mobilization with G-CSF or CD34+ cell count between 7 and 19 (inclusive) on day 5 of mobilization with G-CSF and < 1.3 x 106 CD34+ cells collected by apheresis on day 5 of G-CSF therapy.
< or equal to 5 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
≥ 3 weeks since last cycle of chemotherapy and the beginning of G-CSF mobilization (Rituxan and Lenalidomide are not considered chemotherapy for the purpose of this study)
Total dose of melphalan < or equal to 200 mg
ECOG performance status of 0 or 1
Recovered from all acute toxic effects of prior chemotherapy
Absolute PMN count > 1.0 X 10(9)/l prior to first dose of G-CSF
PLT count > 75 X 10(9)/l prior to first dose of G-CSF
Serum creatinine < or equal to 2.5 mg/dl
SGOT, SGPT and total bilirubin < 2 X upper limit of normal (ULN) prior to the first dose of G-CSF
Cardiac and pulmonary status sufficient to undergo apheresis and transplantation as determined by standard institutional practice
Signed informed consent
Patients of childbearing potential agree to use an approved form of contraception

Exclusion Criteria:

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 (excluding controlled catheter-related bacteremia)
Received prior radio-immunotherapy with Zevalin or Bexxar
Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF
Positive pregnancy test in female patients
Lactating females
Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

G-CSF plus Plerixafor

Arm Description

Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.

Outcomes

Primary Outcome Measures

Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF.

Secondary Outcome Measures

Number of Participants Experiencing a Grade III/IV Toxicity

Safety of plerixafor as measured by Grade III/IV Toxicity

Number of Subjects Experiencing Graft Failure

To investigate the hematological activity of Plerixafor as measured by Graft Failure. Graft failure is defined as failure of initial engraftment (primary graft failure) or initial engraftment, but subsequent loss of hematopoiesis (secondary graft failure).

Days to Absolute Neutrophil Count >500

Number of Subjects Experiencing Durability of Engraftment

Durability of engraftment is defined as the duration and stability of hematopoiesis following autologous transplantation. Subjects who experience durable engraftment have neutrophil counts greater than 500 and platelet counts greater than 20,000 within the specified time frame.

Platelet Engraftment

Days to platelet count >20,000

Full Information

NCT ID

NCT00901225

First Posted

May 4, 2009

Last Updated

April 8, 2014

Sponsor

Duke University

Collaborators

Genzyme, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00901225

Brief Title

Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant

Official Title

Plerixafor Rescue Mobilization For Autologous Stem Cell Transplant Patients With Inadequate Response to G-CSF

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008, Plerixafor received approval from the Food and Drug administration for use in combination with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is not designed to support approval of a new indication or change in the advertising for Plerixafor. The route of administration and dosage level are identical to that which is listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins Lymphoma, there is no known or theoretic increased risk of the use of this drug in this patient population. The study hypothesis for this study is that patients with a circulating CD34+ count < 20 cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.

Detailed Description

This is a single-center, Phase 2, open-label study. All patients diagnosed with non-hodgkins lymphoma, hodgkins disease or multiple myeloma and candidates for autologous transplantation are eligible to enter into the study. The only change to the standard of care is the addition of 240 ug/kg Plerixafor following 5 days of (G-CSF) mobilization. The results of the study will provide both numeric and categorical estimates of measurements of the safety and efficacy of Plerixafor. The primary efficacy endpoint, Treatment Success, is a binary response variable categorizing whether the patient was able to mobilize at least 2 X 10(6) CD34+ cells/kg within 3 days of apheresis. The percentage of patients achieving Treatment Success will be summarized. All AEs will be followed for 30 days after the last apheresis or until the first dose of ablative chemotherapy, whichever occurs first. All SAEs will be followed for 6 months post-transplant or until relapse. All patients who receive at least one dose of Plerixafor will be included in all summaries of AEs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma, Non-Hodgkins Lymphoma, Hodgkins Disease

Keywords

NHL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

G-CSF plus Plerixafor

Arm Type

Experimental

Arm Description

Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.

Intervention Type

Drug

Intervention Name(s)

G-CSF plus Plerixafor

Other Intervention Name(s)

Mozobil, AMD3100

Intervention Description

On Day 5 of G-CSF mobilization, if the patient's peripheral CD34+ cell count is < 7cells/µl then 240ug/kg Plerixafor will be given in the evening prior to receiving 10µg/kg G-CSF and undergoing apheresis the next morning for up to 3 days of apheresis or until ≥ 5x10(6) cells/kg are collected. if the patient's peripheral CD34+ cell count is 7 to 19 cells/ul (inclusive), apheresis will be done. If the apheresis yield is < 1.3x10(6) CD34+ cells/kg then 240ug/kg Plerixafor will be given in the evening prior to receiving 10 µg/kg G-CSF and undergoing apheresis the next morning. If the apheresis yield is at least double that on Day 5, Plerixafor followed the next morning by G-CSF and apheresis will be repeated for up to a total of 3 days of apheresis or until 5x10(6) cells/kg are collected.

Primary Outcome Measure Information:

Title

Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF.

Time Frame

5 days after receiving G-CSF

Secondary Outcome Measure Information:

Title

Number of Participants Experiencing a Grade III/IV Toxicity

Description

Safety of plerixafor as measured by Grade III/IV Toxicity

Time Frame

6 months post transplant or until relapse

Title

Number of Subjects Experiencing Graft Failure

Description

Time Frame

12 months

Title

Days to Absolute Neutrophil Count >500

Time Frame

12 months

Title

Number of Subjects Experiencing Durability of Engraftment

Description

Time Frame

12 months

Title

Platelet Engraftment

Description

Days to platelet count >20,000

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 to 75 years. Diagnosis of NHL, HD or MM Eligible for autologous transplantation CD34+ cell count < 7 cells/ul after 5 days of mobilization with G-CSF or CD34+ cell count between 7 and 19 (inclusive) on day 5 of mobilization with G-CSF and < 1.3 x 106 CD34+ cells collected by apheresis on day 5 of G-CSF therapy. < or equal to 5 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study) ≥ 3 weeks since last cycle of chemotherapy and the beginning of G-CSF mobilization (Rituxan and Lenalidomide are not considered chemotherapy for the purpose of this study) Total dose of melphalan < or equal to 200 mg ECOG performance status of 0 or 1 Recovered from all acute toxic effects of prior chemotherapy Absolute PMN count > 1.0 X 10(9)/l prior to first dose of G-CSF PLT count > 75 X 10(9)/l prior to first dose of G-CSF Serum creatinine < or equal to 2.5 mg/dl SGOT, SGPT and total bilirubin < 2 X upper limit of normal (ULN) prior to the first dose of G-CSF Cardiac and pulmonary status sufficient to undergo apheresis and transplantation as determined by standard institutional practice Signed informed consent Patients of childbearing potential agree to use an approved form of contraception Exclusion Criteria: 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 (excluding controlled catheter-related bacteremia) Received prior radio-immunotherapy with Zevalin or Bexxar Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF Positive pregnancy test in female patients Lactating females Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitchell Horwitz, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant

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