Phase 1
Completed N=107
Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma
Source: ClinicalTrials.gov NCT02335983 ↗Enrolled (actual)
107
Serious AEs
33.6%
Results posted
Nov 2020
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 10; 12; 34; 9 Participants
Summary
The purpose of the study is to assess the safety, tolerability and activity of a once-weekly regimen of carfilzomib in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
10; 12; 34; 9; 9; 33 | — |
| PRIMARY Change From Baseline in Hemoglobin Levels |
116.90; 120.67; 123.24; 111.50; 120.00; 113.21 | — |
| PRIMARY Change From Baseline in Platelet Count |
151.60; 202.50; 172.38; 214.00; 242.89; 233.03 | — |
| PRIMARY Change From Baseline in Neutrophil Count |
2.53; 3.40; 2.72; 3.04; 3.24; 3.26 | — |
| PRIMARY Change From Baseline in Bilirubin |
8.55; 9.98; 9.10; 10.26; 6.84; 7.16 | — |
| PRIMARY Change From Baseline in Creatinine |
80.18; 82.88; 79.09; 75.80; 95.37; 80.60 | — |
| SECONDARY Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group |
11700; 12400 | — |
| SECONDARY Time to Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group |
0.28; 0.27 | — |
| SECONDARY Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group |
4150; 9130 | — |
| SECONDARY Overall Response Rate (ORR) |
90.0; 91.7; 88.2; 89.1; 88.9; 77.8 | — |
| SECONDARY Complete Response Rate (CRR) |
20.0; 16.7; 26.5; 23.9; 22.2; 11.1 | — |
| SECONDARY Progression-free Survival (PFS) |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Duration of Response (DOR) |
NA; NA; NA; NA; NA; NA | — |
Eligibility Criteria
Key Inclusion Criteria
- Newly diagnosed or relapsed multiple myeloma
- Measureable disease by serum M protein, or urine M protein, or serum free light chain (SFLC) and an abnormal serum kappa lambda ratio (for subjects without detectable serum or urine M-protein), or serum quantitative immunoglobulin A (glgA) (for immunoglobulin (Ig) A subjects whose disease can only be reliable measured by qlgA).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
- Left ventricular ejection fraction (LVEF) ≥ 40%
Key Exclusion Criteria
- Waldenström macroglobulinemia
- For newly diagnosed multiple myeloma: multiple myeloma of IgM subtype
- For relapsed disease:
- If treated with a lenalidomide and dexamethasone combination, progression during the first 3 months after initiating treatment.
- Any progression during treatment if the lenalidomide and dexamethasone regimen was the most recent line of therapy.
- Any prior treatment with carfilzomib
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
- Myelodysplastic syndrome
- Amyloidosis
- Prior treatment with carfilzomib or oprozomib
Data sourced from ClinicalTrials.gov (NCT02335983). 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.