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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Dexamethasone, Lenalidomide, Carfilzomib, and Daratumumab in Treating Participants with Multiple Myeloma

This phase II trial studies how well dexamethasone, lenalidomide, carfilzomib, and daratumumab work in treating participants with multiple myeloma. Drugs used in chemotherapy, such as dexamethasone, lenalidomide, and carfilzomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and spread. Giving dexamethasone, lenalidomide, carfilzomib, and daratumumab may work better in treating participants with multiple myeloma.
Not Available
Phase II
Adults
Not Available
Not Available
Cornell, Robert
National
Vanderbilt University
03-04-2019
Treatment
VICCPCL1871
NCT03224507

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Diagnosis of newly diagnosed multiple myeloma with indication for initiation of therapy

Eastern Cooperative Oncology Group (ECOG) performance status 0–2

No prior MM-directed therapy except for dexamethasone (up to 160 mg) and/or bortezomib (up to 5.2 mg/m^2) and/or cyclophosphamide up to 1000 mg/m^2 administered for management of acute manifestations of MM (hypercalcemia, renal impairment, pain) for no longer than 4 weeks prior to enrollment. If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment must be available

Measurable disease, characterized by one of the following parameters: * Serum monoclonal (M) protein >= 1 g/dl by protein electrophoresis * > 200 mg of M protein in the urine on 24 hour electrophoresis * Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio

Life expectancy >= 12 months

Serum alanine aminotransferase (ALT) =
Serum direct bilirubin =
Creatinine clearance (CrCl) >= 40 mL/minute within 21 days prior to start of therapy either measured or calculated using a standard formula (e.g., Cockcroft and Gault)

Written informed consent in accordance with federal, local, and institutional guidelines

Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception. Male subjects must agree to practice contraception

All subjects must agree to comply with and be enrolled in Revlimid Risk Evaluation and Mitigation Strategy (REMS) program



Exclusion Criteria:

Diagnosis of amyloidosis, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS), Waldenstrom’s macroglobulinemia

Major surgery, radiotherapy or infection requiring therapy within 14 days of starting treatment

Known forced expiratory volume in 1 second (FEV1) or corrected carbon monoxide diffusing capability (cDLCO)
Pregnant or lactating females

Known human immunodeficiency virus infection

Active hepatitis B (hepatitis [Hep] B core antibody positive and subsequent Hep B surface antigen positive or Hep B deoxyribonucleic acid [DNA] positive) or hepatitis C infection (Hep C antibody positive and subsequent detectable viral load)

Unstable angina or myocardial infarction within 4 months prior to registration, New York Heart Association (NYHA) class II, III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or grade 3 conduction system abnormalities unless subject has a pacemaker

Cerebrovascular disease manifested as prior stroke at any time or transient ischemic attack (TIA) in the 12 months prior to initiation of therapy

Nonhematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas

Significant neuropathy (grades 3–4, or grade 2 with pain) within 21 days prior to registration

Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)

Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 21 days prior to registration

Contra indication or intolerance to required supportive care medications (aspirin and acyclovir)

Any other clinically significant medical disease or 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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