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An Observational Study of Plerixafor Mobilization Rescue for Autologous Stem Cell Transplant Patients With Inadequate Response to G-CSF


N/A
18 Years
75 Years
Open (Enrolling)
Both
Multiple Myeloma, Non-Hodgkins Lymphoma, Hodgkins Disease

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Trial Information

An Observational Study of Plerixafor Mobilization Rescue for Autologous Stem Cell Transplant Patients With Inadequate Response to G-CSF


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. At total of 20
patients will be enrolled. Enrollment will be stratified such that a total of 10 subjects
will carry the diagnosis of multiple myeloma and have received prior lenalidomide therapy.
The other 10 patients will carry the diagnosis of non-hodgkins lymphoma, hodgkins disease or
multiple myeloma and not have prior therapy with lenalidomide.

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.


Inclusion Criteria:



- Age 18 to 75 years.

- Diagnosis of NHL, HD or MM (cohort A)

- Diagnosis of MM and have had prior therapy with at least 2 cycles of lenalidomide
(cohort B).

- 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 (Section 6.1).

- < or equal to 5 prior regimens of chemotherapy (Rituxan is not considered
chemotherapy for the purpose of this study)

- ≥ 4 weeks since last cycle of chemotherapy and the beginning of G-CSF mobilization
(Rituxan is 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess, among patients with < 20 CD34+ cells/ul after 5 days of mobilization with G-CSF alone, the percentage who achieve > or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.

Outcome Time Frame:

5 days after receiving G-CSF

Safety Issue:

No

Principal Investigator

Mitchell Horwitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00014563

NCT ID:

NCT00901225

Start Date:

May 2009

Completion Date:

May 2015

Related Keywords:

  • Multiple Myeloma
  • Non-Hodgkins Lymphoma
  • Hodgkins Disease
  • NHL
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Duke University Medical CenterDurham, North Carolina  27710