Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet

• Status: Recruiting
• Trial end date: 2026-02-27
• Target enrollment: 0
• Participant gender: All

Summary

A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Lenalidomide; Pomalidomide; Thalidomide

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 International Myeloma Working Group (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 partial response (PR) to at least 1 line of prior therapy

• Prior therapy with PI 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

• Eastern Cooperative Oncology Group (ECOG) Performance Status (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