Trial · NCT04272775
A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
NCT04272775, Phase 1, Terminated, Takeda; results first posted 2020-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM). Trials, record NCT04272775. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04272775
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
- NCT number
- NCT04272775
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 14 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Relapsed and/or Refractory Multiple Myeloma
- Interventions
- Ixazomib, Lenalidomide, Dexamethasone
- First posted
- 2020-02-17
- Last updated
- 2020-03-17
- Results first posted
- 2020-02-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | From Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle length is equal to [=] 28 days) | DLT:Any following adverse events (AEs) possibly related to ixazomib assessed by Common Terminology Criteria for AEs (CTCAE) version 4.03; Grade 4 neutropenia/thrombocytopenia lasting \>7 consecutive days; Grade 3/greater neutropenia with fever/infections; Grade 3/greater thrombocytopenia with clinically significant bleeding; platelet count less than (\<)10,000 per cubic meter(/mm\^3); Grade 2 peripheral neuropathy with pain/Grade 3 or greater peripheral neuropathy; Grade 3/greater nonhematologic toxicities with exceptions of arthralgia/myalgia, fatigue lasting \<7 days manageable nausea/emesis with antiemetic prophylaxis, diarrhea that is controlled with supportive care; treatment delay of \>14 days at start of Cycle 2 due to failure of hematologic/nonhematologic recovery; Other Grade 2/greater ixazomib related nonhematologic toxicities required permanent discontinuation of ixazomib;Inability to receive at least 80% of planned lenalidomide doses due to the AEs related to ixazomib. |
| Primary | Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | |
| Primary | Number of Participants With Grade 3 or Higher TEAE Related to Body Weight | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | Body weight abnormalities were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE). |
| Primary | Number of Participants With Grade 3 or Higher TEAE Related to Vital Signs | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | Vital signs were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE). |
| Primary | Number of Participants With Grade 3 or Higher TEAE Related to 12-lead Electrocardiograms (ECGs) | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | 12-lead ECGs were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE). |
| Primary | Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | Laboratory tests abnormalities were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE). |
| Primary | Cmax: Maximum Observed Plasma Concentration for Ixazomib | Days 1 and 15 of Cycle 1: pre-dose and at multiple time points (15, 30, 60, and 90 minutes and 2, 4, 8, 24, 48, 96, and 168 hours) post-dose (Cycle length=28 days) | |
| Secondary | Number of Participants Who Achieved Complete Response (CR), Very Good Partial Response (VGPR), and Partial Response (PR) | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | Number of participants who achieved CR, PR, VGPR were assessed in accordance to International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma. CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC. VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or greater than or equal to (\>=) 90% decrease in serum M-protein with urine M-protein \<100 milligram per 24 hours (mg/24 hrs). If disease measurable only by SFLC, \>= 90% decrease in the difference between involved and uninvolved FLC levels (dFLC). PR: \>= 50% reduction of serum M-protein and \>= 90% reduction in urine M-protein or to \<200 mg/24 hrs, or a \>= 50% decrease in dFLC. A \>=50% decrease in the size of soft tissue plasmacytomas present at baseline |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | From Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle length is equal to [=] 28 days) | The DLT analysis set consisted of DLT evaluable participants who received at least one dose of ixazomib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | The safety analysis set consisted of all participants who received at least one dose of ixazomib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Grade 3 or Higher TEAE Related to Body Weight | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | The safety analysis set consisted of all participants who received at least one dose of ixazomib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Grade 3 or Higher TEAE Related to Vital Signs | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | The safety analysis set consisted of all participants who received at least one dose of ixazomib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Grade 3 or Higher TEAE Related to 12-lead Electrocardiograms (ECGs) | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | The safety analysis set consisted of all participants who received at least one dose of ixazomib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | The safety analysis set consisted of all participants who received at least one dose of ixazomib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Cmax: Maximum Observed Plasma Concentration for Ixazomib | Days 1 and 15 of Cycle 1: pre-dose and at multiple time points (15, 30, 60, and 90 minutes and 2, 4, 8, 24, 48, 96, and 168 hours) post-dose (Cycle length=28 days) | The pharmacokinetic (PK) analysis set consisted of all participants who received at least one dose of ixazomib and has evaluable PK data. The PK analysis set where data at specified time points was available. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants Who Achieved Complete Response (CR), Very Good Partial Response (VGPR), and Partial Response (PR) | Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days) | The response evaluable analysis set consisted of all participants who received at least one dose of ixazomib, have measurable disease at baseline, and at least one postbaseline response assessment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cohort 1: Ixazomib 4.0 mg | 1 | Participants | ||
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 1 | Participants | ||
| Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | Cohort 1: Ixazomib 4.0 mg | 7 | Participants | ||
| Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 7 | Participants | ||
| Number of Participants With Grade 3 or Higher TEAE Related to Body Weight | Cohort 1: Ixazomib 4.0 mg | 0 | Participants | ||
| Number of Participants With Grade 3 or Higher TEAE Related to Body Weight | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 0 | Participants | ||
| Number of Participants With Grade 3 or Higher TEAE Related to Vital Signs | Cohort 1: Ixazomib 4.0 mg | 1 | Participants | ||
| Number of Participants With Grade 3 or Higher TEAE Related to Vital Signs | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 0 | Participants | ||
| Number of Participants With Grade 3 or Higher TEAE Related to 12-lead Electrocardiograms (ECGs) | Cohort 1: Ixazomib 4.0 mg | 0 | Participants | ||
| Number of Participants With Grade 3 or Higher TEAE Related to 12-lead Electrocardiograms (ECGs) | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 0 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Ixazomib 4.0 mg | 7 | |
| Overall Study | STARTED | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 7 | |
| Overall Study | COMPLETED | Cohort 1: Ixazomib 4.0 mg | 0 | |
| Overall Study | COMPLETED | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1: Ixazomib 4.0 mg | 7 | |
| Overall Study | NOT COMPLETED | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 7 |
Source ClinicalTrials.gov
Adverse events204
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1: Ixazomib 4.0 mg | 6 | 7 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 5 | 7 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1: Ixazomib 4.0 mg | 6 | 7 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 4 | 7 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 1: Ixazomib 4.0 mg | 5 | 7 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 4 | 7 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 1: Ixazomib 4.0 mg | 6 | 7 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 2 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: Ixazomib 4.0 mg | 2 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 1 | 7 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Ixazomib 4.0 mg | 0 | 7 |
| Total, all-cause mortality | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 0 | 7 |
| Total, other adverse events | Cohort 1: Ixazomib 4.0 mg | 7 | 7 |
| Total, other adverse events | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 7 | 7 |
| Total, serious adverse events | Cohort 1: Ixazomib 4.0 mg | 4 | 7 |
| Total, serious adverse events | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 2 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone: Number of Participants With Grade 3 or Higher TEAE Related to 12-lead Electrocardiograms (ECGs) | Trial comparisons |
| Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone: Number of Participants With Grade 3 or Higher TEAE Related to Body Weight | Trial comparisons |
| Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Trial comparisons |
| Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone: Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | Trial comparisons |
Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone: Number of Participants Who Achieved Complete Response (CR), Very Good Partial Response (VGPR), and Partial Response (PR) | Trial comparisons |
| Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone: Number of Participants With Grade 3 or Higher TEAE Related to Vital Signs | Trial comparisons |
| Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone: deaths from any cause | Trial comparisons |
| Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04272775
GET https://conductscience.org/api/trials/v1/NCT04272775/results?page=2