Phase 2
Completed N=31
Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT02290431 ↗Enrolled (actual)
31
Serious AEs
45.2%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate — 48.4 Percentage of participants — p=< 0.0001
Summary
The purpose of this study was to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate |
48.4 | < 0.0001 sig |
| SECONDARY Progression Free Survival (PFS) |
15.3 | — |
| SECONDARY Overall Response Rate (ORR) |
80.6 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Minimal Response Rate (MRR) Per Investigator |
9.7 | — |
| SECONDARY Time to Response (TTR) Per Investigator |
1.4 | — |
| SECONDARY Time to Progression/Relapse (TTP) Per Investigator |
15.3 | — |
| SECONDARY Duration of Response (DOR) Per Investigator |
22.7 | — |
| SECONDARY Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score |
112.33; 91.75; 100.33; 125.83; 114.25; 109.92 | — |
| SECONDARY Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf |
106; 156; 37.8; 166; 87.1; 125 | — |
| SECONDARY Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax |
11.5; 18.2; 1.06; 4.38 | — |
| SECONDARY Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax |
2.00; 2.00; 24.0; 24.0 | — |
| SECONDARY Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2 |
13.7; 16.5 | — |
| SECONDARY Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z |
0.0506; 0.0421 | — |
| SECONDARY Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F |
172; 114 | — |
| SECONDARY Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F |
3390; 2720 | — |
Eligibility Criteria
Inclusion Criteria
- Patient had a previous diagnosis of multiple myeloma
- Patient required retreatment for multiple myeloma
- Patient had measurable M component in serum or urine at study screening
Exclusion Criteria
- Primary refractory disease (patients that never reached at least an minor response for over 60 days under any prior therapy)
- Patient who had been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose
- Patient received prior treatment with DAC inhibitors including panobinostat
- Patient had impaired cardiac function, or a prolonged QTc interval at screening ECG
Data sourced from ClinicalTrials.gov (NCT02290431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.