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

Overview

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 and exposed to daratumumab 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), or 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 response of at least very good partial response (VGPR) will have a bone marrow and minimal residual disease (MRD) assessment at 12 and 24 months (± 2 weeks) from start of treatment (unless a MRD assessment was performed within 4 months of 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 and completed at least 2 consecutive cycles of daratumumab.

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 remission 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 ≤ 2, and at least partial response (PR) to 1 line of therapy.

SparkCures ID 1065
Trial Phase Phase 2
Enrollment 85 Patients
Treatments
Trial Sponsors
  • Amgen
NCT Identifier

NCT04191616

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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)
  • Prior treatment with lenalidomide
  • Prior treatment includes completion of at least 2 consecutive cycles of daratumumab
  • Measurable disease with at least 1 of the following assessed within 21 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

US Trial Locations

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more


Rocky Mountain Cancer Center Aurora

Aurora, CO

Rocky Mountain Cancer Center Boulder

Boulder, CO

Rocky Mountain Cancer Center Colorado Springs

Colorado Springs, CO

Millenium Medical Center

Chicago Ridge, IL

Minnesota Oncology and Hematology PA (Minneapolis)

Minneapolis, MN

Texas Oncology Austin Midtown

Austin, TX

Texas Oncology (Fort Worth)

Fort Worth, TX

Texas Oncology

Tyler, TX

Blue Ridge Cancer Care Roanoke

Roanoke, VA

Alabama
Colorado
Rocky Mountain Cancer Center Aurora

Aurora, CO

Rocky Mountain Cancer Center Boulder

Boulder, CO

Rocky Mountain Cancer Center Colorado Springs

Colorado Springs, CO

Connecticut
Illinois
Millenium Medical Center

Chicago Ridge, IL

Minnesota
Minnesota Oncology and Hematology PA (Minneapolis)

Minneapolis, MN

New Jersey
Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more

Texas
Texas Oncology Austin Midtown

Austin, TX

Texas Oncology (Fort Worth)

Fort Worth, TX

Texas Oncology

Tyler, TX

Virginia
Blue Ridge Cancer Care Roanoke

Roanoke, VA

Resources

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