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Radioimmunotherapy (211At-OKT10-B10) and Chemotherapy (Melphalan) Before Stem Cell Transplantation for the Treatment of Multiple Myeloma

NCT04466475 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-01-31

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of 211At-OKT10-B10 when given together with melphalan before a stem cell transplantation in treating patients with multiple myeloma. The radioimmunotherapy drug 211At-OKT10-B10 is a monoclonal antibody, called OKT10-B10, linked to a radioactive substance called 211At. OKT10-B10 attaches to CD38 positive cancer cells in a targeted way and delivers 211At to kill them. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving 211At-OKT10-B10 with melphalan before a stem cell transplant may kill more cancer cells.

Conditions

  • Plasma Cell Myeloma

Interventions

BIOLOGICAL

Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10

Given IV

DRUG

Melphalan

Given via infusion

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo PBSC transplantation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Damian J. Green · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-27
Primary Completion
2025-10-01
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04466475 on ClinicalTrials.gov