Clinical trial · Interventional
Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma
Phase 1b Study of Carfilzomib Administered Once Weekly in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma
NCT02335983CI-TRIAL-00048172completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carfilzomib | Drug | Carfilzomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- RRMM Dose-evaluation: Carfilzomib 56 mg/m²
- description
- Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
- interventionNames
- Drug: Carfilzomib
- Drug: Lenalidomide
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- RRMM Dose-evaluation: Carfilzomib 70 mg/m²
- description
- Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Newly diagnosed or relapsed multiple myeloma 2. 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). 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2 4. Left ventricular ejection fraction (LVEF) ≥ 40% Key Exclusion Criteria: 1. Waldenström macroglobulinemia 2. For newly diagnosed multiple myeloma: multiple myeloma of IgM subtype 3. For relapsed disease: 1. If treated with a lenalidomide and dexamethasone combination, progression during the first 3 months after initiating treatment. 2. Any progression during treatment if the lenalidomide and dexamethasone regimen was the most recent line of therapy. 3. Any prior treatment with carfilzomib 4. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 5. Plasma cell leukemia (\> 2.0 × 10\^9/L circulating plasma cells by standard differential) 6. Myelodysplastic syndrome 7. Amyloidosis 8. Prior treatment with carfilzomib or oprozomib
References
Publications (1)
- BACKGROUNDBiran N, Siegel D, Berdeja JG, Raje N, Cornell RF, Alsina M, Kovacsovics T, Fang B, Kimball AS, Landgren O. Weekly carfilzomib, lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma: A phase 1b study. Am J Hematol. 2019 Jul;94(7):794-802. doi: 10.1002/ajh.25498. Epub 2019 May 13. PMID 31021005