This phase II trial studies how well daratumumab, bortezomib, and dexamethasone followed by
daratumumab, ixazomib, and dexamethasone in treating patients with multiple myeloma that has
come back (relapsed) or does not response to treatment (refractory). Immunotherapy with
monoclonal antibodies, such as daratumumab, may help the body's immune system attack the
cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in
chemotherapy, such as dexamethasone, 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. Bortezomib and ixazomib may stop the growth of cancer cells by blocking some of
the enzymes needed for cell growth. Giving daratumumab, bortezomib, and dexamethasone
followed by daratumumab, ixazomib, and dexamethasone may work better and help to control
cancer in patients with multiple myeloma.
I. To evaluate the progression-free survival of subjects with daratumumab, bortezomib, and
dexamethasone (DVd) treatment followed by daratumumab, ixazomib, and dexamethasone (DId)
I. To evaluate overall response rate (ORR) as assessed by International Myeloma Working Group
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
After completion of study, patients are followed up at 30 days and then periodically for up
to 24 months.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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