Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Fred Hutchinson Cancer Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Damian J. Green|
|Principal Investigator Affiliation||Fred Hutch/University of Washington Cancer Consortium|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Plasma Cell Myeloma|
OUTLINE: This is a dose-escalation study of 211At-OKT10-B10. Patients receive 211At-OKT10-B10 intravenously (IV) continuously on days -7 to -4 and melphalan via infusion on day -2. Patients then undergo peripheral blood stem cell (PBSC) transplantation on day 0. After completion of study treatment, patients are followed for 30 days, between 80 and 90 days, at 6, 9, 12, 18, and 24 months, and then annually thereafter.
Experimental: Treatment (211At-OKT10-B10, melphalan, PBSC transplantation)
Patients receive 211At-OKT10-B10 IV continuously on days -7 to -4 and melphalan via infusion on day -2. Patients then undergo PBSC transplantation on day 0.
Biological: - Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10
Drug: - Melphalan
Given via infusion
Procedure: - Peripheral Blood Stem Cell Transplantation
Undergo PBSC transplantation
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.