Study of Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in HCT Recipients

• Status: Completed
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic antagonist propranolol is effective in decreasing gene expression of stress-mediated beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic stem cell transplant (HCT) for multiple myeloma.

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

Details

• Lead Sponsor: Medical College of Wisconsin
• Collaborator: University of California, Los Angeles
• Treatments: Adrenergic Agents; Propranolol

Criteria

Inclusion Criteria:

Patients with multiple myeloma receiving an autologous HCT are eligible when the following criteria are met:

1. 18-75 years of age

2. ≤ 1 year since initiation of systemic anti-myeloma therapy

3. Patient is scheduled for autologous hematopoietic stem cell transplant as the upfront therapy for their multiple myeloma

4. Karnofsky Performance Status of ≥90 %; patients eligible for HCT are eligible for the study

5. All men and women must agree to practice effective contraception during the study period if not otherwise documented to be infertile.

Exclusion Criteria:

1. Prior autologous HCT

2. Non secretory multiple myeloma

3. Concurrent beta-blocker therapy at or within 3 weeks of study entry.

4. Previous intolerance to beta-blocker therapy

5. Any medical contraindications to beta-blocker therapy including, but not limited to, symptomatic hypotension; drug hypersensitivity; sinus bradycardia, sick sinus syndrome, or 2nd or 3rd degree atrioventricular block without a pacemaker; uncompensated heart failure; or uncontrolled asthma

6. Active, untreated depression screened for by the HCT physician (Patients who screen positive will be offered a referral to the Medical College of Wisconsin Psycho-Oncology program for further evaluation and treatment)

7. Concurrent use of medications as specified in the protocol throughout the study or within one week of study entry.

8. Pregnant or lactating women