Clinical trial NCT02535182: Pilot Study Using Propranolol To Promote Prenylation Of Gtpase Rap1b In Hematopoietic Stem Cell Transplant Recipients
Official title: Pilot Study Using Propranolol To Promote Prenylation Of The Gtpase Rap1b In Hematopoietic Stem Cell Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Transplantation
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are enrolled in the parent study (NCT02420223) are eligible for this ancillary study.

Brief summary: This is a an ancillary study designed to explore whether an additional cell signaling pathway (prenylation of Rap1) that was recently identified as being under beta-adrenergic control may be affected by beta-blocker use.

Detailed description: This is a proof of concept randomized controlled pilot study assessing whether prenylation and membrane localization of Rap1 in PBMCs can be altered in individuals undergoing autologous Hematopoietic Cell Transplant (HCT) for Multiple Myeloma by administering a daily beta-blocker (propranolol) to 20 participants. Outcomes of patients on this clinical trial will be compared to 20 participants in a control arm.

Eligibility 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 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.
8. Pregnant or lactating women

Primary outcomes:
measure: Prenylation levels in response to propranolol in a population of patients undergoing autologous hematopoietic stem cell transplantation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Jennifer Knight, MD
role: PRINCIPAL_INVESTIGATOR
References: