Efficacy of NF-kB Inhibition for Reducing Symptoms During Maintenance Therapy in Multiple Myeloma Patients

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if curcumin can reduce the symptoms reported by patients with multiple myeloma (MM) who receive treatment with lenalidomide.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Institutes of Health (NIH)
• Treatments: Curcumin; Lenalidomide

Criteria

Inclusion Criteria:

1. Must have a histologically confirmed diagnosis of multiple myeloma.

2. Must be >/= 18 years of age.

3. Must have a performance status (ECOG PS) of 0-2.

4. Must be qualified and have signed consent to receive lenalidomide for maintenance therapy for MM.

5. Must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.

6. Must also agree to refrain from use of self prescribed curcumin during the course of the study.

7. Must have negative pregnancy test before signing consent for MM therapy.

Exclusion Criteria:

1. Unable to understand the symptom assessment or not willing to participate in the study.

2. Treatment for other carcinomas within the last 5 years, except for cured non-melanoma skin and treated in-situ cervical cancer.

3. Uncontrolled intercurrent illness including, but not limited to, ongoing or requiring IV antibiotics, cardiac disease (NYHA class III or IV heart failure), unstable angina pectoris, unstable cardiac arrhythmia or tachycardia, or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.

4. Concurrent use of coumadin other than low dose (1 mg) coumadin used for line patency.

5. Concurrent use of cimetidine, allopurinol, or aluminium hydroxide and magnesium hydroxide-containing antacids such as Maalox.

6. Sorivudine and brivudine use within 4 weeks of the start of study treatment.

7. Gastric or duodenal ulcers, or gastric hyperacidity disorders.

8. Currently receiving anticoagulants (heparin) or antiplatelets (clopidogrel, ticlopidine, aspirin/dipyridamole)

9. INR > 1.5 (upper limit of normal = 1.5).

10. History of deep vein thrombosis.

11. Received allogeneic transplant.

12. Allergy to turmeric, Curcumin, or yellow dye.

13. Bowel or bile duct obstruction.