Phase 2
Completed N=25
Study of Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in HCT Recipients
Source: ClinicalTrials.gov NCT02420223 ↗Enrolled (actual)
25
Serious AEs
20.0%
Results posted
Jun 2021
Primary outcomePrimary: Beta-adrenergically Mediated Gene Expression (Change From Baseline) — -0.407; 0.0099 Unitless — p=.017
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beta-adrenergically Mediated Gene Expression (Change From Baseline) |
-0.407; 0.0099 | .017 sig |
| SECONDARY Patient-reported Depression and Anxiety Scores |
7.3; 7.4; 4.4; 5.2 | — |
| SECONDARY Number of Subjects Experiencing Engraftment Syndrome as a Function of Beta-blocker Administration |
6; 3 | — |
| SECONDARY Time (Days) to Neutrophil Engraftment |
10.5; 11.9 | 0.14 |
| SECONDARY Time (Days) to Platelet Engraftment |
16.6; 19.6 | 0.41 |
| SECONDARY Number of Participants Diagnosed With Culture-positive Infection or Neutropenic Fever Greater Than 100.4 Degrees Fahrenheit |
1; 6 | 0.06 |
| SECONDARY Number of Participants With Myeloma Response as a Function of Beta-blocker Administration |
1; 0; 5; 5; 5; 5 | — |
Eligibility Criteria
Inclusion Criteria
Patients with multiple myeloma receiving an autologous HCT are eligible when the following criteria are met:
- 18-75 years of age
- ≤ 1 year since initiation of systemic anti-myeloma therapy
- Patient is scheduled for autologous hematopoietic stem cell transplant as the upfront therapy for their multiple myeloma
- Karnofsky Performance Status of ≥90 %; patients eligible for HCT are eligible for the study
- All men and women must agree to practice effective contraception during the study period if not otherwise documented to be infertile.
Exclusion Criteria
- Prior autologous HCT
- Non secretory multiple myeloma
- Concurrent beta-blocker therapy at or within 3 weeks of study entry.
- Previous intolerance to beta-blocker therapy
- 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
- 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)
- Concurrent use of medications as specified in the protocol throughout the study or within one week of study entry.
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT02420223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.