ATRA, Celecoxib, and Itraconazole as Maintenance

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Iowa
• Treatments: Celecoxib; Hydroxyitraconazole; Itraconazole; Tretinoin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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