Trial document
DRKS00022250
Trial Description
Title
A Randomized, prospektivE pilot triAL on exercising during treatment in FItting TransplaNt Eligible patientS with Symptomatic multiple myeloma
Trial Acronym
REAL-FITNESS
URL of the Trial
[---]*
Brief Summary in Lay Language
Exercising in patients with mutliple myeloma, who received induction therapy (VCD).
Brief Summary in Scientific Language
Symptomatic MM at Initial diagnosis and planned induction therapy VCD (Bortezomib, Cyclophosphamide, Dexamethasone). Two arms receiving/not receiving exercising.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00022250
- 2020/10/05
- [---]*
- yes
- Approved
- 173/20, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
- [---]*
Health Condition or Problem studied
- C90.0 - Multiple myeloma
Interventions/Observational Groups
- exersicing
- no exercising
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Blinded
- patient/subject
- Control group receives no treatment
- Supportive care
- Parallel
- N/A
- No
Primary Outcome
Feasibility with ist aim of a multicentric, randomised clinical trial.
Secondary Outcome
(1) Evaluation of Revised Myeloma Comorbiditiy Index (R-MCI) due to differences in physical active vs. inactive MM-patients. (2) Event Free Survival (EFS).
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Planned
- 2020/11/01
- 30
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
(1) Symptomatic MM at inital diagnosis. (2) Planned induction therapy with VCD followed by transplantation at UKF.
Exclusion Criteria
(1) Spinal cord compression or unstable fractures. (2) Severe cardial diseases or arrythmia (NYHAE 3-4). (3) Chronic cardial diseases (NYHAE 3-4). (4) Other severe diseases not allowing physical activity and exercising (e. g. severe neurological disorder).
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Freiburg
- Hugstetter Strasse 49
- 79095 Freiburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätaklinikum Freiburg
- Ms. Prof. Dr. Monika Engelhardt
- Hugstetter Str. 55
- 79106 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +4976127032460
- +497612709633180
- monika.engelhardt at uniklinik-freiburg.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsklinikum Freiburg
- Ms. M. A. Mandy-Deborah Möller
- Breisacher Str. 115
- 79106 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +4976127078171
- [---]*
- mandy-deborah.moeller at uniklinik-freiburg.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Universitätsklinikum Freiburg
- Hugstetter Strasse 49
- 79095 Freiburg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting planned
- [---]*
Trial Publications, Results and other Documents
- [---]*