Trial · NCT02057640
MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Multiple Myeloma
NCT02057640, Phase 1, Phase 2, Completed, Jason Valent; results first posted 2019-12-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Multiple Myeloma. Trials, record NCT02057640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02057640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Multiple Myeloma
- NCT number
- NCT02057640
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Jason Valent
- Conditions
- Multiple Myeloma, Kahler Disease, Plasma-Cell Myeloma, Myelomatosis
- Interventions
- Panobinostat, Dexamethasone, MLN9708
- First posted
- 2014-02-07
- Last updated
- 2019-12-11
- Results first posted
- 2019-12-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicity According to CTCAE Version 4.03 | at 28 days from start of treatment | Number of Participants with Dose Limiting Toxicity of MLN9708 (lxazomib) according to CTCAE version 4.03 |
| Secondary | Response to Combination Therapy (Panobinostat, Dexamethasone, MLN9708) | 4 months (102 days) | Response to intervention as measured by international uniform response criteria and clinical benefit response according to modified EBMT response criteria, comparing myeloma panels obtained at the beginning of each cycle that include SPEP, 24 h UPEP, serum and urine IFEs, and serum free light chains to results at screening. In addition a baseline bone marrow exam and skeletal survey will be obtained and repeated as clinically indicated and for assessment of complete remission (bone marrow) |
| Secondary | Progression-free Survival | 1 year from start of treatment | Progression-free survival will be the number of days from study entry to progression or death of any cause, whichever comes first. Progression-free survival is survival with absence of progressive disease, defined by * An increase of 25% from lowest response value in any one or more of the following: * Serum M-component (absolute increase must be \>0.5 g/100 ml) \* * Urine M-component (absolute increase must be \>200mg per 24 h) * Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be \>100 mg/l) * Bone marrow plasma cell percentage (absolute % must be \>10%) * And / or: * Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum calcium \>11.5 mg/100 ml) that can be attributed solely to the plasma cell proliferative disorder |
| Secondary | Overall Survival | up to 3 years from start of treatment | Overall survival for all will be the number of months from study entry to death from any cause. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicity According to CTCAE Version 4.03 | at 28 days from start of treatment | All participants who received treatment in the phase I portion of the study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response to Combination Therapy (Panobinostat, Dexamethasone, MLN9708) | 4 months (102 days) | participants | NUMBER | |
| SECONDARY | Progression-free Survival | 1 year from start of treatment | months | MEDIAN | |
| SECONDARY | Overall Survival | up to 3 years from start of treatment | months | MEDIAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicity According to CTCAE Version 4.03 | Dose Levels 1 | 4 | Participants | ||
| Response to Combination Therapy (Panobinostat, Dexamethasone, MLN9708) | DL1 - 3mg Lxazomib | 0 | participants | ||
| Response to Combination Therapy (Panobinostat, Dexamethasone, MLN9708) | DL2 - 4mg Lxazomib | 0 | participants | ||
| Progression-free Survival | DL1 - 3mg Lxazomib | 1.2 | 95% Confidence Interval 0.7 to 6.0 | months | |
| Progression-free Survival | DL2 - 4mg Lxazomib | 3.5 | 95% Confidence Interval 0.9 to 7.4 | months | |
| Overall Survival | DL1 - 3mg Lxazomib | 12.8 | 95% Confidence Interval 1.7 to 30.4 | months | |
| Overall Survival | DL2 - 4mg Lxazomib | 17.6 | 95% Confidence Interval 11.9 to 22.9 | months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Weeks 1-4 | STARTED | DL1 - 3mg Lxazomib | 4 | |
| Weeks 1-4 | STARTED | DL2 - 4mg Lxazomib | 3 | |
| Weeks 1-4 | COMPLETED | DL1 - 3mg Lxazomib | 4 | |
| Weeks 1-4 | COMPLETED | DL2 - 4mg Lxazomib | 3 | |
| Weeks 1-4 | NOT COMPLETED | DL1 - 3mg Lxazomib | 0 | |
| Weeks 1-4 | NOT COMPLETED | DL2 - 4mg Lxazomib | 0 | |
| Phase II Portion of Study at DL2 | STARTED | DL1 - 3mg Lxazomib | 0 | |
| Phase II Portion of Study at DL2 | STARTED | DL2 - 4mg Lxazomib | 9 | |
| Phase II Portion of Study at DL2 | COMPLETED | DL1 - 3mg Lxazomib | 0 | |
| Phase II Portion of Study at DL2 | COMPLETED | DL2 - 4mg Lxazomib | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events110
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 | anemia | Blood and lymphatic system disorders | DL1 - 3mg Lxazomib | 1 | 4 | |
| other | anemia | Blood and lymphatic system disorders | DL2 - 4mg Lxazomib | 4 | 12 | |
| other | Lymphocyte count decreased | Blood and lymphatic system disorders | DL1 - 3mg Lxazomib | 0 | 4 | |
| other | Lymphocyte count decreased | Blood and lymphatic system disorders | DL2 - 4mg Lxazomib | 4 | 12 | |
| other | Lymphocyte count increased | Blood and lymphatic system disorders | DL1 - 3mg Lxazomib | 0 | 4 | |
| other | Lymphocyte count increased | Blood and lymphatic system disorders | DL2 - 4mg Lxazomib | 1 | 12 | |
| other | Neutrophil count decreased | Blood and lymphatic system disorders | DL1 - 3mg Lxazomib | 0 | 4 | |
| other | Neutrophil count decreased | Blood and lymphatic system disorders | DL2 - 4mg Lxazomib | 3 | 12 | |
| other | Platelet count decreased | Blood and lymphatic system disorders | DL1 - 3mg Lxazomib | 1 | 4 | |
| other | Platelet count decreased | Blood and lymphatic system disorders | DL2 - 4mg Lxazomib | 4 | 12 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DL1 - 3mg Lxazomib | 4 | 4 |
| Total, all-cause mortality | DL2 - 4mg Lxazomib | 9 | 12 |
| Total, other adverse events | DL1 - 3mg Lxazomib | 4 | 4 |
| Total, other adverse events | DL2 - 4mg Lxazomib | 12 | 12 |
| Total, serious adverse events | DL1 - 3mg Lxazomib | 1 | 4 |
| Total, serious adverse events | DL2 - 4mg Lxazomib | 5 | 12 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DL1 - 3mg Lxazomib vs DL2 - 4mg Lxazomib: Response to Combination Therapy (Panobinostat, Dexamethasone, MLN9708) | Trial comparisons |
| DL1 - 3mg Lxazomib vs DL2 - 4mg Lxazomib: deaths from any cause | Trial comparisons |
| DL1 - 3mg Lxazomib vs DL2 - 4mg Lxazomib: 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/NCT02057640
GET https://conductscience.org/api/trials/v1/NCT02057640/events?page=2