Collection of Transplant Stem Cells for Plasma Cell Myeloma
Plasma Cell Myeloma · Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01547806 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Filgrastim (Drug); Plerixafor (Drug); Apheresis (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis |
98 | — |
| PRIMARY Percentage of Patients Requiring 2 Days to Achieve at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight |
2 | — |
| PRIMARY Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW)) |
6.4 | — |
| PRIMARY Median and Standard Deviation of Cluster of Differentiation 34 (CD34) Cells Collected (Per Kg Recipient Body Weight) (BW) |
6.3 | — |
| PRIMARY Range of Cluster of Differentiation 34 (CD34) Cells Collected |
6.3 | — |
| PRIMARY 25th and 75th Percentile Values of Cluster of Differentiation 34 (CD34) Cells Collected |
4.0; 8.0 | — |
| PRIMARY Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM) |
49 | — |
| SECONDARY Number of Participants With Serious and Non-Serious Adverse Events |
16 | — |
| SECONDARY Percentage of Patients That Required Plerixafor + Granulocyte-colony Stimulating Factor (G-CSF) And Only G-CSF (no Plerixafor) |
47; 53 | — |
| SECONDARY Percentage of Patients That Achieved or Did Not Achieve 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg |
65; 35 | — |
| SECONDARY Percentage of Patients That Achieved ≥ 2 x 10^6 But Less Than 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg (Day One Collection) |
31 | — |
| SECONDARY Degree of Tumor Cell Contamination in the Final Product |
— | — |
| SECONDARY Impact of Plerixafor in the Degree of Tumor Cell Contamination in the Final Product |
— | — |
Summary
Eligibility Criteria
- INCLUSION CRITERIA:
Multiple Myeloma Criteria:
Subjects with an indication for autologous hematopoietic cell transplant (AHCT) for the treatment of PCM as determined by the principal investigator (PI) or lead associate investigator (LAI).
- Subjects following induction treatment for plasma cell myeloma (PCM)
- Subjects with recurrent or persistent evaluable disease who have not undergone AHCT for the treatment of the PCM.
Other Eligibility Criteria:
Age greater than or equal to 18 years and less than or equal to 75 years. In subjects between 65 and 75 years of age, physiologic age and co-morbidity will be thoroughly evaluated before enrolling.
Karnofsky performance status of 70% or greater (Eastern Cooperative Oncology Group ((ECOG) 0 or 1)
Ejection fraction (EF) by multigated acquisition scan (MUGA) or 2-D echocardiogram within institution normal limits. In case of low ejection fraction (EF), the subject may remain eligible after a stress echocardiogram is performed if the EF is more than 35% and if the increase in EF with stress is estimated at 10% or more.
Hemoglobin (Hgb) greater than or equal to 8 g/dl (transfusion acceptable)
No history of abnormal bleeding tendency.
Patients must be able to give informed consent
EXCLUSION CRITERIA
Prior allogeneic stem cell transplantation
Hypertension not adequately controlled by 3 or less medications.
Clinically significant cardiac pathology: myocardial infarction within 6 months prior to enrollment, Class III or IV heart failure according to New York Heart Association (NYHA), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Specifically, any history of cardio-vascular pathology or symptoms, not clearly fitting this exclusion criterion will prompt an evaluation by a Clinical Center Cardiologist and eligibility will be considered on a case-by-case basis. Should the cardiologist deem the patients findings on work-up to be not clinically significant pathology, the patient will have met this exclusion criterion.
Patients with a history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis.
Active hepatitis B or C infection
Human immunodeficiency virus (HIV) seropositive, with positive confirmatory nucleic acid test
Patients known or found to be pregnant.
Patients of childbearing age who are unwilling to practice contraception.
Patients may be excluded at the discretion of the principal investigator (PI)/lead associate investigator (LAI) if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.
Data sourced from ClinicalTrials.gov (NCT01547806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.