A Study of Carfilzomib Plus Dexamethasone in Adults With Relapsed or Refractory Multiple Myeloma at US Community Oncology Centers

Stopped early · Phase 2

Conditions studied: Relapsed or Refractory Multiple Myeloma

In brief

The primary objective was to describe the safety profile of carfilzomib plus dexamethasone regimen in adults with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy at study entry.

Key facts

Study ID

NCT03512353

Run by

Amgen

People needed

7

Starts

2018-07-05

Expected to finish

2020-01-16

Last updated by the study team

2021-01-08

Who can join

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

You may qualify if…

• Subject has provided informed consent prior to initiation of any study specific activities/procedures.
• Males or females greater than or equal to 18 years of age.
• Relapsed MM after last treatment or refractory while receiving non-proteasome inhibitor therapy.
• Measurable disease with at least 1 of the following assessed within 21 days prior to enrollment:
• Immunoglobulin G (IgG) MM: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL
• IgA, IgD, 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 to 1.
• Subjects must have at least partial response (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 MM (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy).
• Prior therapy with a proteasome inhibitor (PI) is allowed as long as the subject had at least a PR to most recent therapy with PI, was not removed due to toxicity (except for neuropathy), did not relapse within 60 days from discontinuation of PI, and will have at least a 6-month PI treatment-free interval from last dose received until enrollment. (Subjects may receive maintenance therapy with drugs that are not PI during this 6-month PI treatment-free interval).

You may not qualify if…

• Waldenström macroglobulinemia.
• Multiple myeloma of IgM subtype.
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
• History of plasma cell leukemia.
• Primary amyloidosis (patients with multiple myeloma with asymptomatic deposition of amyloid plaques found on biopsy would be eligible if all other criteria are met).
• Subjects with nephrotic range proteinuria (greater than or equal to 3 g albumin for 24 hours urine OR greater than or equal to 2 g albumin/1 g of creatinine on a random urine specimen).
• Myelodysplastic syndrome.
• History of other malignancy within the past 5 years, with the following exceptions:
• Malignancy treated with curative intent and with no known active disease present for greater than or equal to 3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• Adequately treated cervical carcinoma in situ without evidence of disease.
• Adequately treated breast ductal carcinoma in situ without evidence of disease.
• Prostatic intraepithelial neoplasia without evidence of prostate cancer.
• Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
• Treated medullary or papillary thyroid cancer.
• Similar neoplastic conditions with an expectation of greater than 95% five-year disease-free survival.
• Known human immunodeficiency virus (HIV) infection, hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response following antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response with antiviral therapy directed at hepatitis B are allowed).
• Acute or chronic graft-versus-host disease (any grade).
• Acute active infection requiring systemic antibiotics, antifungal, antiviral (except antiviral therapy directed at hepatitis B) agents within 14 days prior to enrollment.
• Known cirrhosis.
• Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior to enrollment.
• Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment.
• Uncontrolled hypertension, defined as an average systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg. Subjects with controlled hypertension are eligible.
• Hepatic dysfunction within 21 days prior to enrollment: bilirubin 1.5 times the upper limit of normal (ULN) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 3 times the ULN
• Active congestive heart failure with or without reduced ejection fraction (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT interval (QTc) of greater than 470 msec, pericardial disease, myocardial infarction within 4 months prior to enrollment.

Where it is running

• Research Site — Palm Springs, California, United States
• Research Site — Riverside, California, United States
• Research Site — Glenwood Springs, Colorado, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Orange City, Florida, United States
• Research Site — Pensacola, Florida, United States
• Research Site — Honolulu, Hawaii, United States
• Research Site — River Forest, Illinois, United States
• Research Site — Tinley Park, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Paducah, Kentucky, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Midland, Michigan, United States
• Research Site — Jackson, Mississippi, United States
• Research Site — Lincoln, Nebraska, United States
• Research Site — Florham Park, New Jersey, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Hendersonville, North Carolina, United States
• Research Site — Pinehurst, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Zanesville, Ohio, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Rock Hill, South Carolina, United States
• Research Site — Corpus Christi, Texas, United States

Full record on ClinicalTrials.gov

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