Multiple Myeloma Clinical Trial

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

Summary

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

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Full Description

An Open-label, Phase 2 Study Treating Subjects with First or Second Relapse of Multiple Myeloma with Carfilzomib, Pomalidomide, and Dexamethasone (KPd)

This trial is designed to estimate the efficacy of a carfilzomib-based triplet in first or second relapse of multiple myeloma for subjects refractory to lenalidomide. The study is an open-label, phase 2 trial. Subjects may receive treatment until progression.

Myeloma disease status will be monitored locally for response and progression per International Myeloma Working Group (IMWG) criteria (Kumar et al, 2016) every 28 ± 7 days from cycle 1 day 1 until confirmed progressive disease (PD), death, lost to follow-up, or withdrawal of full consent (whichever occurs first), regardless of cycle duration, dose delays or treatment discontinuation. Subjects with a suspected complete response (CR) or better will have a bone marrow for minimal residual disease (MRD) assessment at 12 and 24 months (± 4 weeks) from start of treatment (unless a MRD assessment was performed within 4 months before planned assessment).

Subjects who end study drug(s) without confirmed PD are required to complete disease response assessments and report new anti-myeloma treatment every 28 ± 7 days until first subsequent anti-myeloma treatment, death, lost to follow-up, withdrawal of full consent, confirmed PD, or end of study, whichever occurs first. Subjects who discontinue treatment and either start new antimyeloma treatment or have PD will enter long-term follow-up every 12 weeks until death or end of study.

Approximately one-third of subjects enrolled in the study will be in first relapse and two-thirds in second relapse.

This study will enroll adults ≥ 18 years of age with first or second relapse multiple myeloma.

Eligible subjects will have relapsed multiple myeloma after receiving 1 or 2 prior lines of therapy.

Subjects must be refractory to lenalidomide. Subjects may not have received prior pomalidomide. Prior exposure to a proteasome inhibitor is allowed. Subjects previously exposed to carfilzomib must have responded with at least a partial response to carfilzomib, must not have discontinued carfilzomib due to toxicity, may not have relapsed while receiving or within 60 days of the last dose of carfilzomib, and must have at least a 6 month carfilzomib treatment-free interval since their last dose of carfilzomib.

Subjects must have measurable disease per IMWG consensus criteria, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2, and at least partial response (PR) to 1 line of therapy.

View Eligibility Criteria

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 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

54

Study ID:

NCT04191616

Recruitment Status:

Active, not recruiting

Sponsor:

Amgen

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There are 44 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
Rocky Mountain Cancer Centers Denver Midtown
Denver Colorado, 80218, United States
Yale Cancer Center
New Haven Connecticut, 06510, United States
Affiliated Oncologists, LLC
Chicago Ridge Illinois, 60415, United States
Minnesota Oncology Hematology PA
Saint Paul Minnesota, 55102, United States
Oncology Hematology Care Incorporated
Cincinnati Ohio, 45236, United States
Texas Oncology - Austin Midtown
Austin Texas, 78705, United States
United States Oncology Regulatory Affairs Corporate Office
Austin Texas, 78705, United States
US Oncology Research Investigational Products Center
Austin Texas, 78705, United States
Baylor Charles A Sammons Cancer Center at Dallas
Dallas Texas, 75246, United States
Texas Oncology, Fort Worth
Fort Worth Texas, 76104, United States
Texas Oncology- Tyler
Tyler Texas, 75702, United States
Blue Ridge Cancer Care
Roanoke Virginia, 24014, United States
Aalborg Universitetshospital
Aalborg , 9000, Denmark
Aarhus Universitetshospital
Aarhus N , 8200, Denmark
Sjaellands Universitetshospital
Roskilde , 4000, Denmark
Vejle Sygehus
Vejle , 7100, Denmark
North Estonia Medical Centre
Tallinn , 13419, Estonia
CHU Grenoble Alpes
Grenoble Cedex 9 , 38043, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
Lille Cedex , 59037, France
Centre Hospitalier Universitaire de Nantes
Nantes Cedex 1 , 44093, France
Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut Lévêque
Pessac Cedex , 33604, France
Centre Hospitalier de Saint Quentin
Saint Quentin , 02321, France
Clinique Sainte Anne
Strasbourg , 67000, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse cedex 9 , 31059, France
Klinikum Chemnitz gGmbH
Chemnitz , 09113, Germany
Asklepios Klinik Altona
Hamburg , 22763, Germany
Universitätsklinikum Münster
Münster , 48149, Germany
Universitatsklinikum Tubingen
Tubingen , 72076, Germany
University General Hospital of Evros-Alexandroupolis District
Alexandroupoli , 68100, Greece
General Hospital Evangelismos
Athens , 10676, Greece
Alexandra Hospital
Athens , 11528, Greece
University Hospital of Ioannina
Ioannina , 45500, Greece
General University Hospital of Patras Panagia i Voithia
Patra , 26504, Greece
Theagenion Cancer Hospital of Thessaloniki
Thessaloniki , 54007, Greece
General Hospital of Thessaloniki Georgios Papanikolaou
Thessaloniki , 57010, Greece
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona , 60126, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia , 25123, Italy
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
Lecce , 73100, Italy
Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
Torino , 10126, Italy
Hospital Clinico Universitario de Salamanca
Salamanca Castilla León, 37007, Spain
Hospital Universitari Germans Trias i Pujol
Badalona Cataluña, 08916, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona Cataluña, 08036, Spain
Hospital Universitari i Politecnic La Fe
Valencia Comunidad Valenciana, 46026, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

54

Study ID:

NCT04191616

Recruitment Status:

Active, not recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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