Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT03622775|
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Plasma Cell Myeloma||Biological: Daratumumab||Phase 2|
I. To estimate the complete remission rate (CRR) by the International Myeloma Working Group (IMWG) criteria within 9 months post salvage auto-transplant with daratumumab maintenance therapy starting approximately 3 months post salvage auto-transplant in patients with relapsed myeloma.
I. To evaluate progression-free survival (PFS).
I. To discover the impact of daratumumab on graft function and immune reconstitution.
Beginning 60-120 days after transplant, participants receive daratumumab intravenously (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.
After completion of study treatment, participants are followed up at 30 and 90 days, then every 4-12 weeks thereafter.
|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|
|Actual Study Start Date :||April 11, 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) defined as achieving a negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow [ Time Frame: At course 6 of therapy ]The student t-test/Wilcoxon rank test and analysis of variance (ANOVA)/Kruskal-Wallis test, or chi-squared test/Fisher's exact test will be used to test associations between the response and the prognostic factors. Complete remission will be estimated along with a 95% credible interval.
- Progression-free survival (PFS) [ Time Frame: From the date of initiation of maintenance therapy assessed up to 2 years ]Will be summarized descriptively using the Kaplan-Meier method (including the median, 95% confidence interval, and survival curve). The proportion of patients alive and without disease progression at 6 months of daratumumab maintenance therapy will be summarized. The estimate will be accompanied by a two-sided exact 95% binomial confidence interval. In addition, a Cox regression analysis may be performed if demographic and clinical factors potentially affecting PFS are identified.
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 Qazilbashfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Muzaffar H. Qazilbash 713-792-8750|
|Principal Investigator: Muzaffar H. Qazilbash|
|Principal Investigator:||Muzaffar H Qazilbash||M.D. Anderson Cancer Center|