Multiple Myeloma Study

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.

Print