Hematopoietic Stem Cell TransplantationNCT02535182
Pilot Study Using Propranolol To Promote Prenylation Of Gtpase Rap1b In Hematopoietic Stem Cell Transplant Recipients
An observational study of Hematopoietic Stem Cell Transplantation, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Blood Draw
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are enrolled in the parent study (NCT02420223) are eligible for this ancillary study.
Who may be able to join
- 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.
Who cannot join
- 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 MCW 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Pilot Study Using Propranolol To Promote Prenylation Of The Gtpase Rap1b In Hematopoietic Stem Cell Transplant Recipients
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.
Read the 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.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- Blood Draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
Lab will draw one tube of blood to be stored in 8 mL Becton Dickinson (BD) Vacutainer Cell Preparation Tube (CPT) tubes at three study time points as described in Table 4.7b. These time points include baseline, Day -2 (immediately prior to transplant, central line placement, or administration of any conditioning regimen), and Day +28.
Peripheral blood mononuclear cells (PBMCs) will be isolated from the whole blood samples collected from patients at the three designated time points (Baseline, Day -2, and Day +28). The lab will conduct western blotting on the cytosolic and membrane fractions of isolated PBMCs to determine the distribution of Rap1 in the different fractions, and the status of Rap1 prenylation in the cells.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Patients who participate as controls on the main study will be controls on this ancillary study. The control arm will have blood drawn at baseline, day -2 and day -28 for the Rap1 testing. Receives: Other: Blood Draw | |
| Propranolol Arm | Patients who participate on the propranolol arm on the main study will be on the propranolol arm on this ancillary study. The propranolol arm will have blood drawn at baseline, day -2 and day -28 for the Rap1 testing. Receives: Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenylation levels in response to propranolol in a population of patients undergoing autologous hematopoietic stem cell transplantation
Level of prenylation will be compared between patients exposed vs. not exposed to propranolol from 1-3 weeks before to 4 weeks following transplantation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2018
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer M. Knight, Medical College of Wisconsin
- Investigators
- Jennifer Knight, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535182
- Sponsor's protocol ID
- 24391
- Status last verified
- Feb 2020
- First submitted
- 25 Aug 2015
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Using Propranolol To Promote Prenylation Of The Gtpase Rap1b In Hematopoietic Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT02535182
- Acronym / sponsor ID
- 24391
- Conditions
- Hematopoietic Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | – | Other: Blood DrawPatients who participate as controls on the main study will be controls on this ancillary study. The control arm will have blood drawn at baseline, day -2 and day -28 for the Rap1 testing. |
| Propranolol Arm | – | Other: Blood DrawPatients who participate on the propranolol arm on the main study will be on the propranolol arm on this ancillary study. The propranolol arm will have blood drawn at baseline, day -2 and day -28 for the Rap1 testing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are enrolled in the parent study (NCT02420223) are eligible for this ancillary study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawLab will draw one tube of blood to be stored in 8 mL Becton Dickinson (BD) Vacutainer Cell Preparation Tube (CPT) tubes at three study time points as described in Table 4.7b. These time points include baseline, Day -2 (immediately prior to transplant, central line placement, or administration of any conditioning regimen), and Day +28. Peripheral blood mononuclear cells (PBMCs) will be isolated from the whole blood samples collected from patients at the three designated time points (Baseline, Day -2, and Day +28). The lab will conduct western blotting on the cytosolic and membrane fractions of isolated PBMCs to determine the distribution of Rap1 in the different fractions, and the status of Rap1 prenylation in the cells. | Other | Control Arm, Propranolol Arm |
Primary outcome
Prenylation levels in response to propranolol in a population of patients undergoing autologous hematopoietic stem cell transplantation
Time frame: 1 year
Level of prenylation will be compared between patients exposed vs. not exposed to propranolol from 1-3 weeks before to 4 weeks following transplantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Knight, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenylation levels in response to propranolol in a population of patients undergoing autologous hematopoietic stem cell transplantation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.