The purpose of this study is to evaluate the percentage of participants with a response of very good partial response (VGPR) or better to IDd treatment.
The regimen being tested in this study is the combination of ixazomib, daratumumab, and dexamethasone. This study will look at the efficacy and safety of IDd in people who have RRMM. The study will enroll approximately 60 Participants. Participants will be assigned to the treatment group: • Ixazomib 4.0 mg + Daratumumab 16.0 mg/kg + Dexamethasone 20 mg All participants will be asked to take Ixazomib on Days 1, 8 and 15 of each 28-day cycle plus Daratumumab on Days 1, 8, 15 and 22 of each 28-day cycle for Cycles 1 and 2, on Days 1 and 15 of each 28-day cycle for Cycles 3 through 6 and on Day 1 of each 28-day cycle for Cycle 7 and beyond plus Dexamethasone orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle. This multi-center trial will be conducted in the United States, Czech Republic, France, Poland, Greece and the Netherlands. The overall time to participate in this study is approximately 5 years. Participants will make multiple visits to the clinic, and every 12 weeks after PD until death or termination of the study by the sponsor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Ixazomib capsule.
Daratumumab IV infusion.
Dexamethasone tablets.
Percentage of Participants With Very Good Partial Response (VGPR) or Better (Complete Response + VGPR)
Response was assessed using International Myeloma Working Group (IMWG) Criteria. VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours. The percentage of participants were rounded off to the single decimal point.
Time frame: Up to 5 years
Progression-free Survival (PFS)
PFS is defined as time from date of first dose of drug to date of first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Participant without documentation of PD or death were censored at the date of last response assessment that is stable disease (SD) or better. PD is defined as increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/dl); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dl); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder. SD is defined as not meeting criteria for other responses.
Time frame: Up to 5 years
Time to Progression (TTP)
TTP is defined as the time from the first dose of any study drug treatment to the date of the first documented PD. PD is defined as increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/dl); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dl); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
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Pacific Cancer Medical Center
Anaheim, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
SCRI - Florida Cancer Specialists - Panhandle
Tallahassee, Florida, United States
Research Medical Center - Kansas City
Kansas City, Missouri, United States
SCRI - Tennessee Oncology - Nashville - Centennial
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Fakultni Nemocnice Olomouc
Olomouc, Olomouc Region, Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague, Prague, Czechia
Fakultni Nemocnice Ostrava
Ostrava - Poruba, Severomoravsky KRAJ, Czechia
Fakultni Nemocnice Brno
Brno, Czechia
...and 18 more locations
Time frame: Up to 5 years
Overall Survival (OS)
OS is defined as the time from the date of first dose of any study drug treatment to the date of death. Participant without documentation of death at the time of analysis will be censored at the last visit at which s/he was known to be alive.
Time frame: Up to 5 years
Overall Response Rate (ORR)
ORR is defined as percentage of participants with complete response (CR), VGPR and partial response (PR). CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; normal free light chain (FLC) ratio of 0.26-1.65; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein + urine M-protein level \<100 mg/24 hours; and PR: \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions. The percentage of participants were rounded off to the single decimal point.
Time frame: Up to 5 years
Time To Response (TTR)
TTR is defined as the time from first dose of any study drug treatment to the date of first documentation of PR or better. PR is defined as \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions.
Time frame: Up to 5 years
Duration of Response (DOR)
DOR is defined as the time from the date of first documentation of PR or better to the date of the first documented PD among participants who responded to the treatment.
Time frame: Up to 5 years