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

Overview

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.

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

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Oncology Hematology Care Inc. (Kenwood)

Deer Park, OH

Texas Oncology Austin Midtown

Austin, TX

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 (Fort Worth)

Fort Worth, TX

Texas Oncology

Tyler, TX

Oncology & Hematology Associates

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

Ohio
Oncology Hematology Care Inc. (Kenwood)

Deer Park, OH

Texas
Texas Oncology Austin Midtown

Austin, TX

Texas Oncology (Fort Worth)

Fort Worth, TX

Texas Oncology

Tyler, TX

Virginia
Oncology & Hematology Associates

Roanoke, VA

Resources

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