A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Overview

Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.

SparkCures ID 1011
Trial Phase Phase 3
Enrollment 460 Patients
Treatments
Trial Sponsors
  • Amgen
NCT Identifier

NCT03859427

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:

  • Documented relapse or progressive multiple myeloma on or after any treatment (subjects refractory to the most recent line of therapy are eligible, unless last treatment contained PI or lenalidomide and dexamethasone).
  • Subjects must have at least PR to at least 1 line of prior therapy.
  • Subjects must have received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation maintenance therapy will be considered as 1 line of therapy).
  • Prior therapy with a PI or lenalidomide and dexamethasone is allowed, as long as the patient had at least a PR to most recent therapy with PI or lenalidomide and dexamethasone, was not removed due to toxicity, and will have at least a 6-month PI or lenalidomide and dexamethasone treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with lenalidomide during this 6-month PI or lenalidomide and dexamethasone treatment-free interval).
  • Previous treatment with a lenalidomide and dexamethasone containing regimen is allowed, as long as the subject did not progress during the first 3 months after initiating lenalidomide and dexamethasone containing therapy.
  • Measurable disease with at least 1 of the following assessed within 21 days prior to randomization:
    • Inmunoglobulin G (IgG) multiple myeloma: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL
    • Inmunoglobulin A (IgA), Inmunoglobulin D (IgD), Inmunoglobulin E (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
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 ≤ 2
  • Other inclusion criteria may apply

Exclusion Criteria:

  • Waldenström macroglobulinemia.
  • Multiple myeloma of Inmunoglobulin M (IgM) subtype.
  • Plasma cell leukemia (> 2.0 × 10^9 /L circulating plasma cells by standard differential).
  • Uncontrolled hypertension, defined as an average systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg despite optimal treatment (measured following European Society of Hypertension/European Society of Cardiology 2013 guidelines).
  • Active congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, screening ECG with corrected QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization.
  • Calculated or measured creatinine clearance < 1.0 mL/s (calculation must be based on the Cockcroft and Gault formula) within 21 days prior to randomization.
  • Other exclusion criteria may apply

US Trial Locations

Accepting Patients

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

Compassionate Cancer Care

Fountain Valley, CA

The Hospital of Central Connecticut

New Britain, CT

California
Compassionate Cancer Care

Fountain Valley, CA

Connecticut
The Hospital of Central Connecticut

New Britain, CT

Texas

Resources

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