Phase 2
N=54
Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet
Relapsed or Refractory Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT04191616 ↗Enrolled (actual)
54
Serious AEs
42.3%
Results posted
Nov 2023
Primary outcome: Primary: Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC) — 57.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carfilzomib (Drug); Dexamethasone (Drug); Pomalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC) |
57.7 | — |
| SECONDARY Percentage of Participants With a Minimal Residual Disease Negative Complete Response (MRD[-]CR) as Assessed by the IRC |
3.8 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
50 | — |
| SECONDARY Number of Participants Achieving MRD[-] Response |
5 | — |
| SECONDARY Number of Participants With Sustained MRD[-]CR for at Least 12 Months as Assessed by the IRC |
— | — |
| SECONDARY Number of Participants With Sustained MRD[-]CR at Month 24 as Assessed by the IRC |
— | — |
| SECONDARY Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC |
20.3 | — |
| SECONDARY Time to Response as Assessed by the IRC |
1.0 | — |
| SECONDARY Kaplan-Meier Estimate of Progression Free Survival (PFS) as Assessed by the IRC |
11.1 | — |
| SECONDARY Kaplan-Meier Estimate of Overall Survival (OS) |
17.6 | — |
| SECONDARY Number of Participants With Best Overall Confirmed Response of CR or Better as Assessed by the IRC |
3 | — |
Summary
A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04191616). 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.