Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)

Completed · Phase 1

Conditions studied: Multiple Myeloma, Renal Impairment

In brief

The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function.

Key facts

Study ID

NCT01575925

Run by

Celgene

People needed

25

Starts

2012-06-01

Expected to finish

2018-08-07

Last updated by the study team

2022-11-04

Who can join

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

You may qualify if…

• Subjects must satisfy the following criteria to be enrolled in the study:
• Must be ≥ 18 years at the time of signing the informed consent form
• Must understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures
• Must be able to adhere to the study visit schedule and other protocol requirements
• Must have documented diagnosis of relapsed or refractory multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours)
• Must have had at least 1 prior anti-myeloma regimen
• Must have documented progression as per the International Myeloma Working Group uniform response criteria (Durie, 2006) during or after the last anti-myeloma regimen
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
• Females of childbearing potential (FCBP) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation, and must agree to regular pregnancy testing during this timeframe
• Females must agree to abstain from breastfeeding during study participation and for 28 following discontinuation from study treatment
• Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from study treatment, even if he has undergone a successful vasectomy
• Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from study treatment
• All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from study treatment
• All subjects must agree not to share medication

You may not qualify if…

• The presence of any of the following will exclude a subject from enrollment:
• Peripheral neuropathy ≥ Grade 2
• Non-secretory multiple myeloma
• Any of the following laboratory abnormalities:
• Absolute neutrophil count (ANC) < 1,000/µL
• Platelet count < 75,000/µL
• Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
• Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted)
• Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) > 3.0 x upper limit of normal (ULN)
• Serum total bilirubin > 2.0 mg/dL
• Prior history of malignancies, other than the disease being studied, unless the subject has been free of the malignancy for ≥ 5 years from initiating study treatment, with the following exceptions:
• Basal cell carcinoma of the skin
• Squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system).
• Previous therapy with Pomalidomide
• Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
• Rash ≥ Grade 3 during prior thalidomide or lenalidomide therapy
• Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
• Subjects with any one of the following:
• Congestive heart failure (New York Heart Association Class III or IV)
• Myocardial infarction within 12 months prior to starting study treatment
• Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
• Subjects who received any of the following within the last 14 days of initiation of study treatment:

Where it is running

• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Ingalls Cancer Research Center — Harvey, Illinois, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Weill Cornell Medical College — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
• L'Hotel Dieu de Quebec — Québec, Canada

Full record on ClinicalTrials.gov

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