Overview

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