Multiple myeloma Cancer
Conditions
Interventions
Hypothesis
This project will be conducted as a pilot trial to address key uncertainties in designing a definitive randomised controlled trial, which will test the hypothesis that cycling during a stem
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion Criteria for Patient Donors The donor can be included if they have/ are: 1.1. A clinical diagnosis of Myeloma 1.2. A scheduled autologous stem cell collection 1.3. > 18 years old 1.4. The capacity to consent to taking part in the study 1.5. A consultant determined score of ‘0’ or ‘1’ on the ECOG Performance Status Scale 1.6. Consultant and donor agree that donor is capable of lightly pedalling for a maximum of 12 minutes per hour during the stem cell collection 2. Inclusion Criteria for Volunteer Donors The donor can be included if they have/ are: 2.1. > 18 years old 2.2. A scheduled allogeneic stem cell collection 2.3. The capacity to consent to taking part in the study 2.4. Are able to lightly pedal for a maximum of 12 minutes per hour of their stem cell collection, and their consultant agrees 3. Inclusion Criteria for Survey 3.1. > 18 years old 3.2. Have the capacity to consent to taking part in the study 3.3. All people with a clinical diagnosis of myeloma will be included 3.4. All people who have previously undertaken a peripheral blood stem cell collection will be included (patients with myeloma and allogeneic (volunteer matched) donors) 3.5. All healthcare professionals who have previously worked with donors receiving a peripheral blood stem cell collections will be included 3.6. Family members of close friends of people who have previously undertaken a peripheral blood stem cell collections will be included 4. Eligibility Criteria for Interviews (Donors) A CYCLE participant in the STEM-Ex study 5. Eligibility Criteria for Interviews (Healthcare Professionals) 5.1. Directly involved in stem cell collections 5.2. Involved in the STEM-Ex study
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria for Patient Donors The donor will be excluded if they have/ are: 1.1. Uncontrolled blood pressure 1.2. Previously had a stem cell transplant 1.3. Joint problems that might limit ability to cycle e.g., bony deposits, osteoarthritis, collapsed spine, spine compression and/or an unstable spine 1.4. An abnormal electrocardiogram (ECG), which measures heart rhythm 1.5. Additional health conditions that might put them at risk during this study e.g. brain and/or lung conditions 1.6. Pregnant or planning a pregnancy 2. Exclusion Criteria for Volunteer Donors The donor will be excluded if they have/ are: 2.1. Uncontrolled blood pressure 2.2. Joint problems that might limit your ability to cycle e.g., osteoarthritis 2.3. An abnormal ECG measurement 2.4. Additional health conditions that might put them at risk for this study e.g. heart complications, brain and/or lung conditions 2.5. Pregnant or planning a pregnancy 3. Eligibility Criteria for Survey Not fulfilling one of the three inclusion criteria 4. Eligibility Criteria for Interviews (Donors and Healthcare Professionals) Not fulfilling one of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of stem cell collection measured using flow cytometry to quantify CD34+ cells collected per minute at the end of stem cell collection | — |
Secondary
| Measure | Time frame |
|---|---|
| Final CD34+ dose measured using flow cytometry to quantify CD34+ cells per kg of body mass at the end of stem cell collection;Time to achieve the target dose measured using flow cytometry to quantify CD34+ cells per hour and day at the end of stem cell collection;Engraftment outcomes measured using flow cytometry to quantify neutrophil, lymphocyte and platelet recovery at a time point following stem cell transplant;Feasibility outcomes measured using study data recording recruitment, adherence and attrition rate at the end of stem cell collection;Acceptability outcomes measured using symptom questionnaires: for autologous donors, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC myeloma-specific module (EORTC QLQ-MY20); and, for allogenic donors, the Short Form-12 (SF-12) quality of life questionnaire, and an interview, at a time point during and following the stem cell collection;Physiological outcomes, including the rating of perceived exertion, continuous heart rate monitoring, pedal cadence, and cycling interval average power output measured using the Borg scale, a wristwatch (beats per minute and % of age-predicted heart rate maximum), and pedals at during the stem cell collection;Immunological outcomes measured using flow cytomtery to quantify concentrations of immune cell subsets at pre and post stem cell collection | — |
Countries
United Kingdom
Contacts
Public ContactPhoebe;- Cox;Study Team
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Outcome results
None listed