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MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Multiple Myeloma
Phase 1, PHASE2 trial testing Panobinostat in Multiple Myeloma in 16 participants. Completed in 15 May 2018.
| Lead sponsor | Jason Valent |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 22 May 2014 |
| Primary completion | 15 May 2018 |
| Estimated completion | 15 May 2018 |
| Sites | 2 locations across United States |
Jason Valent
18 and older, any sex, with Multiple Myeloma or Kahler Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants with Dose Limiting Toxicity of MLN9708 (lxazomib) according to CTCAE version 4.03
| Group | Value | 95% CI |
|---|---|---|
| Dose Levels 1 | 4 |
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)
| Group | Value | 95% CI |
|---|---|---|
| DL1 - 3mg Lxazomib | 0 | |
| DL2 - 4mg Lxazomib | 0 |
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 \
| Group | Value | 95% CI |
|---|---|---|
| DL1 - 3mg Lxazomib | 1.2 | 0.7 – 6.0 |
| DL2 - 4mg Lxazomib | 3.5 | 0.9 – 7.4 |
Overall survival for all will be the number of months from study entry to death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| DL1 - 3mg Lxazomib | 12.8 | 1.7 – 30.4 |
| DL2 - 4mg Lxazomib | 17.6 | 11.9 – 22.9 |
Time frame: 30 days post last study drug administration. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | DL1 - 3mg Lxazomib | DL2 - 4mg Lxazomib |
|---|---|---|---|
| Lung Infection | Infections and infestations | — | — |
| Hyperviscosity | Infections and infestations | — | — |
| Gastric hemorrhage | Gastrointestinal disorders | — | — |
| Skin Infection | Skin and subcutaneous tissue disorders | — | — |
| Urinary retention | Renal and urinary disorders | — | — |
| Atrial Fibrillation | Cardiac disorders | — | — |
| Reaction | System | DL1 - 3mg Lxazomib | DL2 - 4mg Lxazomib |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| anemia | Blood and lymphatic system disorders | — | — |
| Lymphocyte count decreased | Blood and lymphatic system disorders | — | — |
| Platelet count decreased | Blood and lymphatic system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Neutrophil count decreased | Blood and lymphatic system disorders | — | — |
| White blood cell decreased | Blood and lymphatic system disorders | — | — |
| fatigue | General disorders | — | — |
| vomiting | Gastrointestinal disorders | — | — |
| creatinine increased | Investigations | — | — |
| dizziness | Nervous system disorders | — | — |
| anorexia | Metabolism and nutrition disorders | — | — |
| fever | General disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| headache | Nervous system disorders | — | — |
| constipation | Gastrointestinal disorders | — | — |
| irritability | General disorders | — | — |
| tremors | Nervous system disorders | — | — |
| abdominal pain | Gastrointestinal disorders | — | — |
| Hypohosphatemia | Metabolism and nutrition disorders | — | — |
| Hemoglobinuria | Renal and urinary disorders | — | — |
| Lymphocyte count increased | Blood and lymphatic system disorders | — | — |
| edema face | General disorders | — | — |
| scalp psoriasis | Skin and subcutaneous tissue disorders | — | — |
| bruising | Skin and subcutaneous tissue disorders | — | — |
| respiratory infection | Infections and infestations | — | — |
| blurred vision | Eye disorders | — | — |
| dyspepsia | Gastrointestinal disorders | — | — |
| flatulence | Gastrointestinal disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Hypalbuminemia | Metabolism and nutrition disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Breast infection | Infections and infestations | — | — |
| Bronchial infection | Infections and infestations | — | — |
Most-reported serious reactions: Lung Infection, Hyperviscosity, Gastric hemorrhage, Skin Infection, Urinary retention, Atrial Fibrillation.
Data from ClinicalTrials.gov NCT02057640 adverse events section.
This study will look at the safety and tolerability of the new drug MLN9708 in combination with the existing drugs panobinostat and dexamethasone among patients with relapsed or refractory multiple myeloma. This study will also look at the response and clinical benefit of the treatment and the progression-free survival and overall survival of study participants.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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