Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03763162|
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : July 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma||Drug: Bortezomib Biological: Daratumumab Drug: Dexamethasone Drug: Ixazomib Other: Quality-of-Life Assessment||Phase 2|
I. To evaluate the progression-free survival of subjects with daratumumab, bortezomib, and dexamethasone (DVd) treatment followed by daratumumab, ixazomib, and dexamethasone (DId) treatment.
I. To evaluate overall response rate (ORR) as assessed by International Myeloma Working Group Criteria (IMWG).
II. To evaluate time to response (TTR). III. To evaluate time to progression (TTP). IV. To evaluate duration of response (DOR). V. To evaluate overall survival (OS). VI. To evaluate the safety and tolerability. VII. To evaluate minimal residual disease (MRD) rate. VIII. To evaluate quality of life (QoL) using the Treatment Satisfaction Questionnaire for Medication (TSMQ-9) and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) patient reported questionnaires.
I. To evaluate biomarkers of response to treatment and mechanisms of resistance with pretreatment and post-treatment bone marrow and blood samples with deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) sequencing and immune profiling by flow cytometry.
Patients receive daratumumab intravenously (IV) over 3.5-6.5 hours on days 1, 8, and 15, bortezomib subcutaneously (SC) on days 1, 4, 8, and 11, and dexamethasone IV over 15 minutes on days 1, 8, and 15 and orally (PO) on days 2, 4, 5, 9, 11, 12, and 16. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive daratumumab IV over 3.5 hours on days 1 and 15 of cycles 4-7 and day 1 of subsequent cycles, ixazomib PO on days 1, 8, and 15, and dexamethasone IV over 15 minutes or PO once weekly. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up at 30 days and then periodically for up to 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Daratumumab, Bortezomib, and Dexamethasone (DVd), Followed by Daratumumab, Ixazomib, and Dexamethasone (DId) for Relapsed and/or Refractory Myeloma|
|Actual Study Start Date :||January 17, 2019|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Treatment (daratumumab, bortezomib, dexamethasone, ixazomib)
Patients receive daratumumab IV over 3.5-6.5 hours on days 1, 8, and 15, bortezomib SC on days 1, 4, 8, and 11, and dexamethasone IV over 15 minutes on days 1, 8, and 15 and PO on days 2, 4, 5, 9, 11, 12, and 16. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive daratumumab IV over 3.5 hours on days 1 and 15 of cycles 4-7 and day 1 of subsequent cycles, ixazomib PO on days 1, 8, and 15, and dexamethasone IV over 15 minutes or PO once weekly. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Given IV or PO
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- Progression free survival (PFS) [ Time Frame: From the date of first dose of any study drug treatment to the date of first documentation of progressive disease, or death due to any cause, whichever occurs first, assessed up to 18 months ]Will be assessed by International Myeloma Working Group Criteria (IMWG).
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): NCT03763162
|Contact: Hans Leefirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Hans C. Lee 713-745-8430 email@example.com|
|Principal Investigator: Hans C. Lee|
|Principal Investigator:||Hans C Lee||M.D. Anderson Cancer Center|