18 and older, any sex, with Relapsed and Refractory Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Primary· From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopard
AEs
Group
Value
95% CI
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
3
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
3
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
3
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
3
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
3
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
7
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
4
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
Number of Participants With Clinically Significant Abnormalities Reported as TEAEsPrimary· From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
The number of participants with any clinically significant abnormal standard safety laboratory values collected throughout the study reported as TEAEs. Parameters assessed were hematology, serum chemistry and urinalysis.
Blood Creatinine Increased
Group
Value
95% CI
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
1
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
1
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
1
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
0
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
0
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
1
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
1
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
Number of Participants With a TEAE of Peripheral NeuropathyPrimary· From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
Neurotoxicity was assessed as the number of participants with the TEAE of peripheral neuropathy.
Neuropathy Peripheral
Group
Value
95% CI
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
0
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
1
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
1
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
0
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
0
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
1
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
0
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEsPrimary· From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
The number of participants with any clinically significant changes in vital signs collected throughout the study that were reported as TEAEs. Measurement of vital signs, included oral temperature, blood pressure, and heart rate.
Group
Value
95% CI
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
0
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
0
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
0
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
0
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
0
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
0
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
1
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
Maximum Tolerated Dose (MTD) of IxazomibPrimary· Cycle 1 (21 days)
MTD was highest dose of Ixazomib, at which \<=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT was defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cell per cubic millimeter \[cells/mm\^3\]) for \>7 days;Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia (platelets \< 25,000/mm\^3) for \>7 days;Grade 3 thrombocytopenia with clinically significant bleeding; platelet count \<10,000/mm\^3; Grade 2 peripheral neuropathy with pain or \>=Grade 3 peripheral neu
Group
Value
95% CI
Ixazomib (All Groups)
2
Recommended Phase 2 Dose (RP2D) of IxazomibPrimary· Cycle 1 through Cycle 39 (Up to 28.3 months)
The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK) and pharmacodynamic data observed in Cycle 1 and beyond.
Group
Value
95% CI
Ixazomib (All Groups)
2
Cmax: Maximum Observed Plasma Concentration for IxazomibSecondary· Cycle 1, Days 1 and 11: Predose and at multiple time points (up to 264 hours) postdose
Day 1
Group
Value
95% CI
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
2.120
± 0.3974
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
10.190
± 2.5597
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
22.200
± 11.3137
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
29.000
± 24.1831
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
21.100
± 10.1237
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
68.167
± 34.7876
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
117.933
± 67.1924
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for IxazomibSecondary· Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
Day 1
Group
Value
95% CI
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
1.000
0.57 – 2.00
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
1.000
0.50 – 1.50
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
0.775
0.55 – 1.00
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
0.775
0.50 – 1.05
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
1.000
1.00 – 2.02
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
1.000
0.25 – 1.08
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
1.000
0.72 – 1.08
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for IxazomibSecondary· Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
Day 1
Group
Value
95% CI
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
3.383
± 1.7210
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
20.700
± 4.5255
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
109.000
± 41.0122
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
159.050
± 91.8532
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
251.000
± 62.5060
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
449.000
± 185.9516
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
416.500
± 47.3762
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for IxazomibSecondary· Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 72 hours) postdose
Day 1
Group
Value
95% CI
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
109.00
± 41.012
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
159.05
± 91.853
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
251.00
± 62.506
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
449.00
± 185.952
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
416.50
± 47.376
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
T1/2: Terminal Disposition Phase Elimination Half-life for IxazomibSecondary· Cycle 1, Day 11: predose and at multiple time points (up to 264 hours) postdose
Group
Value
95% CI
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
135.00
± NA
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
126.50
± 2.121
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
129.33
± 25.658
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
105.88
± 21.071
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
92.70
± 8.485
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
Time frame: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
Serious: 0/3 (0%)
Deaths: 0/3
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
Serious: 0/3 (0%)
Deaths: 0/3
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
Serious: 2/3 (67%)
Deaths: 1/3
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
Serious: 2/3 (67%)
Deaths: 0/3
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
Serious: 0/3 (0%)
Deaths: 0/3
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
Serious: 5/7 (71%)
Deaths: 0/7
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
Serious: 3/4 (75%)
Deaths: 0/4
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of Ixazomib administered orally in participants with relapsed and/or refractory multiple myeloma.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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· Phase 4
· recruiting
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· Phase 4
· withdrawn
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· Phase 2
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· Phase 2
· terminated
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· Phase 1
· withdrawn
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Currently open trials in the same condition.
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Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc.
Last refreshed: 7 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00932698.