Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib

Stopped early · Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of this Phase II study is to evaluate the safety and effectiveness (good and bad effects) of carfilzomib given as a 30-minute infusion and at a dose of 70 mg/m2 to treat patients with multiple myeloma (MM), who are currently showing progressive disease (worsening) and had progressed (did not respond to treatment) within 8 weeks of receiving treatment with twice weekly 27mg/m2 of carfilzomib. Carfilzomib is approved by the U.S. Food and Drug Administration (FDA) to be used only in certain U.S. patients with relapsed and refractory multiple myeloma that have tried and failed other therapies. Carfilzomib is considered an investigational drug for this study because the dose and regimen included in this study are different from the FDA approved carfilzomib regimen. Carfilzomib is a type of drug called a proteasome inhibitor. Carfilzomib is thought to work by preventing breakdown of abnormal proteins in cells, causing the cells to die. Cancer cells are more sensitive to these effects than normal cells. Carfilzomib has been previously given to more than 1800 people in clinical trials.

Key facts

Study ID

NCT02294357

Run by

Oncotherapeutics

People needed

45

Starts

2014-12-01

Expected to finish

2020-09-22

Last updated by the study team

2023-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a diagnosis of MM based on standard criteria as follows:
• Major criteria:
• Plasmacytomas on tissue biopsy.
• Bone marrow plasmacytosis (greater than 30% plasma cells).
• Monoclonal immunoglobulin (Ig) spike on serum electrophoresis IgG greater than 3.5 g/dL or IgA greater than 2.0 g/dL; kappa or lambda light chain excretion greater than 1 g/day on 24-hour urine protein electrophoresis.
• Minor criteria:
• bone marrow plasmacytosis (10% to 30% plasma cells)
• monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
• lytic bone lesions
• normal IgM less than 50 mg/dL, IgA less than 100 mg/dL, or IgG less than 600 mg/dL
• Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
• any 2 of the major criteria
• major criterion 1 plus minor criterion 2, 3, or 4
• major criterion 3 plus minor criterion 1 or 3
• minor criteria 1, 2, and 3, or 1, 2, and 4
• Patient must meet one of the following:
• Currently, patient has progressive MM that has progressed while receiving twice weekly carfilzomib 27mg/m2 alone or as part of their last carfilzomib-containing combination regimen
• Currently, the patient is not in CR and plateaued (as defined by unchanged disease markers for at least 8 weeks) while treated with carfilzomib (twice weekly 27 mg/m2) and dexamethasone with or without lenalidomide or pomalidomide
• Patients who were previously receiving a carfilzomib (twice weekly 27 mg/m2) containing regimen and are currently receiving carfilzomib (twice weekly 27mg/m2) and dexamethasone maintenance therapy with or without lenalidomide or pomalidomide and are not in CR and have plateaued
• Patient must have received at least one full cycle of carfilzomib at a dose of twice weekly 27mg/m2 prior to showing evidence of PD or plateauing from their last carfilzomib-containing regimen.
• Patient must have previously received treatment with an immunomodulatory agents lenalidomide or pomalidomide to be eligible for the study (applicable only for subjects who qualify via inclusion criteria 2B or 2C).
• There is no limit to the number of prior lines of therapy that a patient may have received.
• Measurable disease, as defined by one or more of the following (assessed within 14 days prior to first dose):
• Serum M-protein ≥ 0.5 g/dL, or
• Urine M-protein ≥ 200 mg/24 hours, or

You may not qualify if…

• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)
• Waldenström's macroglobulinemia
• Amyloidosis
• Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to first dose
• Cytotoxic chemotherapy with approved or investigational anticancer therapeutics within 28 days prior to first dose
• Treatment with bortezomib (Velcade®), thalidomide, pomalidomide (Pomalyst®) or lenalidomide (Revlimid®) within 21 days prior to first dose
• Focal radiation therapy within 7 days prior to first dose. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to enrollment (i.e., prior radiation must have been to < 30% of the bone marrow)
• Immunotherapy within 21 days prior to first dose
• Major surgery within 21 days prior to first dose
• Active congestive heart failure (New York Heart Association [NYHA] Classes III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to first dose. Echocardiogram or MUGA evidence of left ventricular ejection fraction (LVEF) below institutional normal within 28 days prior to enrollment
• Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at HBV), or antifungal agents within 14 days prior to first dose
• Known human immunodeficiency virus (HIV) seropositivity
• Known active hepatitis B or C virus infection (except for patients with HBV receiving and responding to HBV antiviral therapy: these patients are allowed)
• Patients with known cirrhosis
• Second malignancy within the past 3 years, except:
• Adequately treated basal cell or squamous cell skin cancer
• Carcinoma in situ of the cervix
• Prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
• Breast carcinoma in situ with full surgical resection
• Treated medullary or papillary thyroid cancer
• Patients with myelodysplastic syndrome
• Significant neuropathy (Grades 3 to 4) within 14 days prior to first dose
• Peripheral neuropathy with pain ≥ G2 within 14 days prior to first dose
• Patients with baseline hepatic impairment

Where it is running

• California Cancer Associates for Research & Excellence (cCARE) — Encinitas, California, United States
• Wellness Oncology and Hematology — West Hills, California, United States
• James R Berenson, MD, Inc. — West Hollywood, California, United States
• Cancer Specialists of North Florida — Fleming Island, Florida, United States
• Hudson Valley Hem/Onc Associates — Poughkeepsie, New York, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Blood & Cancer Center of East Texas — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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