Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT03622775|
Recruitment Status : Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : November 1, 2018
The goal of this clinical research study is to learn if daratumumab can help to prevent multiple myeloma (MM) from coming back after patients have had an autologous stem cell transplant (ASCT). The safety of this drug after transplant will also be studied.
This is an investigational study. Daratumumab is FDA approved and commercially available for the treatment of MM. Its use after an ASCT is investigational.
The study doctor can explain how the study drug is designed to work.
Up to 56 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Plasma Cell Myeloma||Biological: Daratumumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Daratumumab for Maintenance in Patients With Relapsed Multiple Myeloma After Salvage Autologous Stem Cell Transplantation|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||March 15, 2020|
|Estimated Study Completion Date :||March 15, 2020|
Experimental: Treatment (daratumumab)
Beginning 60-120 days after transplant, participants receive daratumumab IV over 4-8 hours on days 1, 8, 15 and 22 of courses 1 and 2 and days 1 and 15 of courses 3-6, then on day 1 of subsequent courses. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
- Complete remission rate (CRR) [ Time Frame: 6 months after daratumumab maintenance therapy ]CRR determined by the International Myeloma Working Group (IMWG).
- Progression-free survival (PFS) [ Time Frame: From the date of initiation of maintenance therapy assessed up to 2 years ]Progression-free survival defined as the interval from the date of initiation of maintenance therapy after salvage ASCT to the earlier of the first documentation of objective disease progression or death from any cause.
- Biomarker analysis in the peripheral blood lymphocyte subsets [ Time Frame: Baseline, 1 week after the first dose, 3 months after, and until relapse up to 2 years ]Paired t-test, Mantel-Haenszel (MH) test and generalized linear model may be used to evaluate the changes of those biomarkers.
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): NCT03622775
|Contact: Muzaffar Qazilbashemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: H. firstname.lastname@example.org|
|Principal Investigator:||Muzaffar Qazilbash||M.D. Anderson Cancer Center|