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

Completed · Phase 2

Conditions studied: Relapsed or Refractory Multiple Myeloma

In brief

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

Key facts

Study ID

NCT04191616

Run by

Amgen

People needed

54

Starts

2020-08-06

Expected to finish

2024-10-01

Last updated by the study team

2025-09-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Rocky Mountain Cancer Centers Denver Midtown — Denver, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Affiliated Oncologists, LLC — Chicago Ridge, Illinois, United States
• Minnesota Oncology Hematology PA — Saint Paul, Minnesota, United States
• Oncology Hematology Care Incorporated — Cincinnati, Ohio, United States
• Texas Oncology - Austin Midtown — Austin, Texas, United States
• United States Oncology Regulatory Affairs Corporate Office — Austin, Texas, United States
• US Oncology Research Investigational Products Center — Austin, Texas, United States
• Baylor Charles A Sammons Cancer Center at Dallas — Dallas, Texas, United States
• Texas Oncology, Fort Worth — Fort Worth, Texas, United States
• Texas Oncology- Tyler — Tyler, Texas, United States
• Blue Ridge Cancer Care — Roanoke, Virginia, United States
• Aalborg Universitetshospital — Aalborg, Denmark
• Aarhus Universitetshospital — Aarhus N, Denmark
• Sjaellands Universitetshospital — Roskilde, Denmark
• Vejle Sygehus — Vejle, Denmark
• North Estonia Medical Centre — Tallinn, Estonia
• CHU Grenoble Alpes — Grenoble, France
• Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez — Lille, France
• Centre Hospitalier Universitaire de Nantes — Nantes, France
• Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut Lévêque — Pessac, France
• Centre Hospitalier de Saint Quentin — Saint-Quentin, France
• Clinique Sainte Anne — Strasbourg, France
• Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, France

Full record on ClinicalTrials.gov

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