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Pilot Study Using Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in Hematopoietic Stem Cell Transplant Recipients

Information source: Medical College of Wisconsin
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hematopoietic Stem Cell Transplantation

Intervention: Propranolol (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Medical College of Wisconsin

Official(s) and/or principal investigator(s):
Jennifer Knight, MD, Principal Investigator, Affiliation: Medical College of Wisconsin

Overall contact:
Cancer Center Clinical Trials Office, Phone: 866-680-0505, Ext: 8900, Email: cccto@mcw.edu

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.

Clinical Details

Official title: Randomized Controlled Pilot Study Using Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in Hematopoietic Stem Cell Transplant Recipients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Change in beta-adrenergically mediated gene expression following beta-blocker administration

Secondary outcome:

Change in depression and anxiety as a function of beta-blocker administration

Incidence of engraftment syndrome as a function of beta-blocker administration

Rates of neutrophil and platelet engraftment as a function of beta-blocker administration

Incidence of infection as a function of beta-blocker administration

Differences in myeloma response as a function of beta-blocker administration

Differences in treatment-related mortality as a function of beta-blocker administration

Differences in progression-free survival as a function of beta-blocker administration

Differences in overall survival as a function of beta-blocker administration

Detailed description: This is a randomized controlled pilot study designed to evaluate whether a drug designed to block the physiologic effects of stress is effective at blocking stress-related gene expression in people receiving autologous stem cell transplants (their own cells) for multiple myeloma. Such stress-related gene expression is one way that the body is programmed to make specific proteins under conditions of stress. These proteins are believed to contribute to worse health outcomes. By using the drug propranolol, we aim to see whether we might block these negative health effects of stress as occur in the cancer setting and during the transplant process. We hypothesize that individuals taking propranolol will have more favorable gene expression. We will enroll 40 individuals, randomizing half to receive propranolol and half to serve as the control group not on the study drug. Study participants will start propranolol three weeks prior to their transplant and continue it until 30 days after the transplant. We will explore the effect of socioeconomic status, depression, and anxiety on individuals' gene expression response to propranolol with the idea that the more impoverished, anxious, or depressed individuals will display an even greater change in their gene expression. Part of the purpose of this study is also be to assess whether it is feasible to give this drug to individuals with cancer. Results of this study may inform larger trials assessing the effects of propranolol on cancer progression.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Patients with multiple myeloma receiving an autologous HCT are eligible when the following criteria are met: 1. 18-70 years of age (70 years is the MCW institutional limit to prescribe high dose melphalan as a conditioning regimen) 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. Stable disease, partial response or very good partial response at time of study entry 5. Karnofsky Performance Status of ≥90 %; patients eligible for HCT are eligible for the study 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 MCW 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.

Locations and Contacts

Cancer Center Clinical Trials Office, Phone: 866-680-0505, Ext: 8900, Email: cccto@mcw.edu

Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting
Froedtert Hospital and the Medical College of Wisconsin, Phone: 866-680-0505, Ext: 8900, Email: cccto@mcw.edu
Additional Information

Starting date: July 2015
Last updated: July 21, 2015

Page last updated: August 23, 2015

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