Clinical trial · Interventional
Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet
An Open-label, Phase 2 Study Treating Subjects With First or Second Relapse of Multiple Myeloma With Carfilzomib, Pomalidomide, and Dexamethasone (KPd)
NCT04191616CI-TRIAL-00094502SELECTcompletedPhase 2Results 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)
A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone
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 |
|---|---|---|---|
| Relapsed or Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carfilzomib | Drug | Carfilzomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carfilzomib combined with pomalidomide and dexamethasone
- description
- Carfilzomib, pomalidomide, and dexamethasone (KPd)
- interventionNames
- Drug: Carfilzomib
- Drug: Dexamethasone
- Drug: Pomalidomide
Primary outcomes (1)
- measure
- Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC)
- timeFrame
- From day 1 cycle 1 until the primary analysis (PA) data cutoff (DCO); the mean duration of KPd treatment as of the DCO was 42.0 weeks
- description
- Overall response was defined as the best overall confirmed response of: Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \< 200 mg/24-h. Assessment was by IRC per International Myeloma Working Group Uniform Response Criteria (IMWG-URC). The 90% confidence intervals were estimated using the Clopper-Pearson method (1994).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria * Subject has provided informed consent prior to initiation of any study specific activities or procedures. * Male or female subjects age ≥ 18 years * First or second relapse of multiple myeloma by IMWG criteria (subjects refractory to the most recent line of therapy, excluding carfilzomib, are eligible) * Refractory to lenalidamide * Measurable disease with at least 1 of the following assessed within 28 days prior to enrollment: * IgG multiple myeloma: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL * IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL * urine M-protein ≥ 200 mg per 24 hours * in subjects without measurable serum or urine M-protein, serum-free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio * Must have at least a PR to at least 1 line of prior therapy * Prior therapy with proteasome inhibitors is allowed. Subjects receiving prior carfilzomib therapy must have achieved at least a PR, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and must have at least a 6 month carfilzomib treatment-free interval from their last dose of carfilzomib * ECOG PS of 0 to 2 Exclusion Criteria * Primary refractory multiple myeloma * Waldenström macroglobulinemia * Multiple myeloma of IgM subtype * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * Plasma cell leukemia ( greater than 2.0 × 109/L circulating plasma cells by differential). If automated differential shows ≥ 20% of other cells, obtain manual differential to identify other cells. * Primary amyloidosis (patients with multiple myeloma with asymptomatic deposition of amyloid plaques found on biopsy would be eligible if all other criteria are met) * Previous diagnosis of amyloidosis associated with myeloma * Myelodysplastic syndrome * Toxicity requiring discontinuation of lenalidomide therapy * Prior treatment with pomalidomide
References
Publications (1)
- BACKGROUNDPerrot A, Delimpasi S, Spanoudakis E, Frolund U, Belotti A, Oriol A, Moreau P, McFadden I, Xia Q, Arora M, Dimopoulos MA. An open-label phase 2 study treating patients with first or second relapse of multiple myeloma with carfilzomib, pomalidomide, and dexamethasone (KPd): SELECT study. Leuk Lymphoma. 2024 Jun;65(6):833-842. doi: 10.1080/10428194.2024.2322030. Epub 2024 Mar 18. PMID 38497533