Recruiting

Plerixafor

Sponsor:

Shi, Patricia, M.D.

Code:

NCT01042717

Conditions

Multiple Myeloma

Non-Hodgkins Lymphoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Plerixafor

Study Details

Brief summary:

The purpose of this study is to determine whether it is safe and effective to collect peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after administration of plerixafor.

Conditions

Multiple Myeloma

Non-Hodgkins Lymphoma

Study ID

NCT01042717

Start date

Feb, 2010

Status verified date

Sep, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Autologous donors age 18 to 75 years with NHL or MM scheduled to undergo peripheral blood stem cell collection as part of standard clinical care. Biopsy-confirmed diagnosis of NHL or MM is to have been done prior to the first mobilization.
2. In first or second CR or PR
3. ECOG performance status of 0 or 1
4. WBC count greater than 2.5 x 10e9/1
5. Absolute PMN count greater than 1.5 x 10e9/1
6. PLT count greater than 100 x 10e9/1
7. Serum creatinine less than or equal to 2.2 mg/dl
8. SGOT, SGPT, and total bilirubin less than 2.5 X upper limit of normal (ULN)
9. Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
10. Negative for HIV
11. 4 weeks since last cycle of chemotherapy. (Rituximab, thalidomide, dexamethasone, and bortezomib are not considered chemotherapy for the purpose of the study)
12. Patients of childbearing potential agree to use an approved form of contraception
13. Recovered from all acute toxic effects of prior chemotherapy

Exclusion Criteria:

1. Comorbid condition which renders patient, in view of the investigators, at high risk of treatment complications
2. Failed previous stem cell collections or collection attempts
3. Less than 6 weeks of carmustine prior to the 1st dose of G-CSF
4. Received GM-CSF or pegfilgrastim within 3 weeks prior to the 1st dose of G-CSF for mobilization
5. Received G-CSF within 14 days prior to the 1st dose of G-CSF for mobilization
6. Active CNS involvement
7. Active brain metastases or carcinomatous meningitis
8. Bone marrow involvement greater than 20 percent
9. Received radiation therapy to the pelvis
10. Post-transplant chemotherapy and/or radiation therapy below the diaphragm is anticipated
11. Received prior radio-immunotherapy with Zevalin or Bexxar
12. Fever (temperature greater than 38 C/100.4 F)
13. Received bone-seeking radionuclides (e.g., holmium)
14. A residual acute medical condition resulting from prior chemotherapy
15. Active brain metastases or myelomatous meningitis
16. Received thalidomide, dexamethasone and/or Velcade within 7 days prior to the first dose of G-CSF
17. Received Revlimid within 3 weeks prior to the first dose of G-CSF
18. Received greater than 6 cycles of Revlimid
19. Positive pregnancy test or lactating
20. Active infection requiring antibiotic treatment
21. Abnormal ECG with clinically significant rhythm disturbance (ventricular arrhythmias), or other conduction abnormality in the last year that in the opinion of the investigator warrants exclusion of the subject from the trial.
22. 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.
23. Patients whose apheresis product will be further selected and purified.
24. Prior autologous or allogeneic transplant.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Plerixafor

Plerixafor 16 hours

Interventions

Plerixafor

Plerixafor administered at 16 hours prior to apheresis

Primary outcome measure

  • Percent of donors obtaining a minimum CD34+ cell dose of 2 x 106/kg actual recipient weight within 2 days of collection [ Time Frame: After collection ]

Central Contacts and Locations

Locations

Mount Sinai School of Medicine

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Patricia A Shi, MD

More Information

Sponsor

Shi, Patricia, M.D.

Last update posted

Sep 27, 2011

Last verified

Sep, 2011

Keywords

  • plerixafor
  • autologous transplantation
  • hematopoietic stem cell mobilization
  • multiple myeloma
  • non-Hodgkins lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Shi, Patricia, M.D. on 2011-09-27.