Study of Carfilzomib Administered Once Weekly in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma

Status: Recruiting

Phase: 1b

Sponsor: Amgen

Contact: Jennifer Montgomery, 541-706-6590 or jmontgomery@bmctotalcare.com

Purpose: To evaluate the safety and tolerability of a once-weekly carfilzomib, lenalidomide, and dexamethasone (KRd) regimen in newly diagnosed multiple myeloma (NDMM) subjects.

Inclusion Criteria:

  • Age ≥ 18 years
  • Able to provide written informed consent in accordance with federal, local, and institutional guidelines
  • Newly diagnosed, transplant-eligible or transplant-ineligible multiple myeloma:
    • Symptomatic multiple myeloma (per International Myeloma Working Group [IMWG] diagnostic criteria) and
    • No prior treatment for multiple myeloma
  • Measurable disease with at least 1 of the following assessed within 21 days prior to Cycle 1 Day 1:
    • Serum M-protein ≥ 0.5 g/dL
    • Urine M-protein ≥ 200 mg/24 hour
    • In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
    • For immunoglobulin (Ig) A subjects whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA), a qIgA level of ≥ 750 mg/dL (0.75 g/dL)
  • Eastern Cooperative Onculogy Group (ECOG) Performance Status (PS) of 0 to 2

Exclusion Criteria:

  • Waldenström macroglobulinemia
  • Multiple myeloma of IgM subtype
  • POEMS syndrome (pulyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)
  • Myelodysplastic syndrome
  • Second malignancy within the past 5 years except:
    • Adequately treated basal cell or squamous cell skin cancer, or
    • Carcinoma in situ of the cervix, or
    • Prostate cancer < Gleason score 6 with undetectable prostate-specific antigen (PSA) over 12 months, or
    • Ductal breast carcinoma in situ with full surgical resection (ie, negative margins), or
    • Treated medullary or papillary thyroid cancer, or
    • Similar condition with an expectation of > 95% five-year disease-free survival
  • Amyloidosis
  • Cytotoxic chemotherapy within 28 days prior to Cycle 1 Day 1
  • Immunotherapy within 21 days prior to Cycle 1 Day 1
  • Glucocorticoid therapy within 14 days prior to Cycle 1 Day 1 that exceeds a cumulative dose of 160 mg of dexamethasone
  • Radiation therapy:
    • Focal therapy within 7 days prior to Cycle 1 Day 1
    • Extended field therapy within 21 days prior to Cycle 1 Day 1
  • Prior treatment with carfilzomib or oprozomib
  • Known history of allergy to Captisul (a cyclodextrin derivative used to sulubilize carfilzomib)
  • Contraindication to lenalidomide or dexamethasone
  • Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs or intulerance to hydration due to preexisting pulmonary or cardiac impairment
  • Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrulled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 6 months prior to Cycle 1 Day 1
  • Active infection within 14 days prior to Cycle 1 Day 1 requiring systemic antibiotics
  • Pleural effusions requiring thoracentesis within 14 days prior to Cycle 1 Day 1
  • Ascites requiring paracentesis within 14 days prior to Cycle 1 Day 1
  • Ongoing graft-versus-host disease
  • Uncontrolled hypertension or uncontrolled diabetes
  • Significant neuropathy (≥ Grade 3) within 14 days prior to Cycle 1 Day 1
  • Known cirrhosis
  • Known human immunodeficiency virus (HIV) seropositivity, hepatitis C infection, or hepatitis B infection (subjects with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B are allowed)
  • Participation in another interventional study within 28 days prior to Cycle 1 Day 1
  • Major surgery (except kyphoplasty) within 28 days prior to Cycle 1 Day 1
  • Female subjects who are pregnant or lactating
  • Any other clinically significant medical disease or social condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent.
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