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

  • STATUS
    Recruiting
  • End date
    Feb 27, 2026
  • participants needed
    85
  • sponsor
    Amgen
Updated on 26 August 2021
Investigator
Amgen Call Center
Primary Contact
Affiliated Oncologists, LLC (3.0 mi away) Contact
+82 other location

Summary

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

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. Approximately 85 subjects will be enrolled in the study. 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 85 subjects will be enrolled in the study, with approximately one-third of subjects 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.

Details
Condition Relapsed or Refractory Multiple Myeloma
Treatment Pomalidomide, Dexamethasone, Carfilzomib
Clinical Study IdentifierNCT04191616
SponsorAmgen
Last Modified on26 August 2021

Eligibility

Yes No Not Sure

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
Waldenstrm 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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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