Radioimmunotherapy (211At-OKT10-B10) and Chemotherapy (Melphalan) Before Stem Cell Transplantation for the Treatment of Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04466475|
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|CD38 Positive Plasma Cell Myeloma||Biological: Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10 Drug: Melphalan Procedure: Peripheral Blood Stem Cell Transplantation||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial Evaluating Escalating Doses of 211At-Labeled Anti-CD38 Monoclonal Antibody (211At-OKT10-B10) Combined With Melphalan as Conditioning Prior to Autologous Hematopoietic Cell Transplantation for Patients With Multiple Myeloma|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||March 1, 2024|
|Estimated Study Completion Date :||March 1, 2026|
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
Given via infusion
Procedure: Peripheral Blood Stem Cell Transplantation
Undergo PBSC transplantation
- Maximum tolerated dose [ Time Frame: Up to 30 days post-transplant ]Defined as the occurrence of dose limiting toxicities (DLTs) in 25% of patients, where a DLT is defined as the occurrence of grade III/IV regimen-related toxicity as defined by the Bearman Scale.
- Achievement of response [ Time Frame: Between days +80 to +90 post-transplant ]Measured per the International Myeloma Working Group criteria. The response rates (partial response [PR] or better) will be estimated along with the exact 95% confidence interval.
- Duration of response [ Time Frame: From response (PR or better) to disease relapse or death, assessed up to 5 years ]Duration of response will be estimated using Kaplan-Meier methodology.
- Overall survival [ Time Frame: From transplantation to death, assessed up to 2 years post-transplant ]Kaplan-Meier methodology will be used to estimate the 2-year overall survival.
- Progression-free survival [ Time Frame: From transplantation to disease relapse or death, assessed up to 2 years post-transplant ]Kaplan-Meier methodology will be used to estimate the 2-year progression-free survival.
- Rates of minimal residual disease (MRD) [ Time Frame: At days 28, and +80 to +90 post-transplant ]MRD will be assessed using multi-color flow cytometry and next generation sequencing in conjunction with functional imaging (i.e., positron emission tomography-computed tomography). The proportion who achieve MRD will be estimated along with an exact 95% confidence interval.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466475
|Contact: Damian J. Greenemail@example.com|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Contact: Damian J. Green 206-667-5398 firstname.lastname@example.org|
|Principal Investigator: Damian J. Green|
|Principal Investigator:||Damian J. Green||Fred Hutch/University of Washington Cancer Consortium|