ATRA, Celecoxib, and Itraconazole as Maintenance

Completed · Phase 1

Conditions studied: Relapsed Multiple Myeloma

In brief

The purpose of this study is to evaluate the safety and tolerability associated with the combination of ATRA/celecoxib/itraconazole as maintenance therapy given after an autologous stem cell transplant in relapsed multiple myeloma patients.

Key facts

Study ID

NCT02401295

Run by

University of Iowa

People needed

1

Starts

2015-05-01

Expected to finish

2016-11-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of relapsed multiple myeloma
• Recent salvage transplant (≤ 6 months but ≥ 45 days post-transplant prior to study enrollment) for relapse
• 18-75 years of age at the time of study entry
• Platelet count ≥70K/mm3 un-transfused
• Resolution of all transplant-related toxicity to ≤ grade 2 per CTCAE v.4
• Left ventricular ejection fraction as measured by ECHO or MUGA should be ≥ 40%
• Creatinine of ≤ 2 mg/dl and a calculated GFR of >50mL/min/1.73m2
• A total bilirubin, ALT, AST, and alkaline phosphatase of ≤ 2 ULN
• Performance status of 0-2 based on the ECOG criteria. Patients with performance status 3 or 4, based solely on bone pain, are also eligible, provided that there is a source document to verify this
• Prospective study participants must be informed of the investigational nature of the study and must have signed an IRB-approved informed consent form in accordance with institutional and federal guidelines

You may not qualify if…

• Prior allogeneic transplant
• Greater than grade 2 motor neuropathy or greater than grade 3 sensory neuropathy at screening
• Uncontrolled diabetes
• Recent (< 6 months) myocardial infarction, unstable angina, CABG or stent placement in the last 2 years, difficult-to-control congestive heart failure, uncontrolled hypertension (systolic blood pressure > 160 mm or a diastolic BP > 110 mm under normal conditions and while on appropriate anti-hypertensive medications), or difficult- to-control cardiac arrhythmias
• Evidence of QT prolongation and/or torsades de pointes (TdP) on EKG.
• Any co-morbid condition that poses a greater threat to the patient's life expectancy than the recurrent myeloma
• No concurrent malignancy with a life expectancy of less than two years, or one that requires ongoing chemotherapeutic intervention at screening
• Presence of an infection that requires intravenous antibiotics
• Pregnant or nursing females. Any patient of reproductive potential may not participate unless he/she has agreed to use an effective contraceptive method as covered during the informed consent process
• Known history of an HIV seropositive test

Where it is running

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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