Trial document

drksid header

DRKS-ID: DRKS00022250

Trial Description

start of 1:1-Block title

Title

A Randomized, prospektivE pilot triAL on exercising during treatment in FItting TransplaNt Eligible patientS with Symptomatic multiple myeloma

end of 1:1-Block title

start of 1:1-Block acronym

Trial Acronym

REAL-FITNESS

end of 1:1-Block acronym

start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url

start of 1:1-Block public summary

Brief Summary in Lay Language

Exercising in patients with mutliple myeloma, who received induction therapy (VCD).

end of 1:1-Block public summary

start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Symptomatic MM at Initial diagnosis and planned induction therapy VCD (Bortezomib, Cyclophosphamide, Dexamethasone). Two arms receiving/not receiving exercising.

end of 1:1-Block scientific synopsis

start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

end of 1:1-Block forwarded Data

start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content

start of 1:1-Block organizational data

Organizational Data

DRKS-ID: DRKS00022250
Date of Registration in DRKS: 2020/10/05
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 173/20, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

end of 1:1-Block organizational data

start of 1:n-Block secondary IDs

Secondary IDs

[---]*

end of 1:n-Block secondary IDs

start of 1:N-Block indications

Health Condition or Problem studied

ICD10: C90.0 - Multiple myeloma

end of 1:N-Block indications

start of 1:N-Block interventions

Interventions/Observational Groups

Arm 1: exersicing
Arm 2: no exercising

end of 1:N-Block interventions

start of 1:1-Block design

Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject
Control: Control group receives no treatment
Purpose: Supportive care
Assignment: Parallel
Phase: N/A
Off-label Drug use: No

end of 1:1-Block design

start of 1:1-Block primary endpoint

Primary Outcome

Feasibility with ist aim of a multicentric, randomised clinical trial.

end of 1:1-Block primary endpoint

start of 1:1-Block secondary endpoint

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).

end of 1:1-Block secondary endpoint

start of 1:n-Block recruitment countries

Countries of Recruitment

DE: Germany

end of 1:n-Block recruitment countries

start of 1:n-Block recruitment locations

Locations of Recruitment

University Medical Center Freiburg im Breisgau

end of 1:n-Block recruitment locations

start of 1:1-Block recruitment

Recruitment

Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2020/11/01
Target Sample Size: 30
Monocenter/Multicenter trial: Monocenter trial
National/International: National

end of 1:1-Block recruitment

start of 1:1-Block inclusion criteria

Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

end of 1:1-Block inclusion criteria

start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

(1) Symptomatic MM at inital diagnosis. (2) Planned induction therapy with VCD followed by transplantation at UKF.

end of 1:1-Block inclusion criteria add

start of 1:1-Block exclusion criteria

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).

end of 1:1-Block exclusion criteria

start of 1:n-Block addresses

Addresses

Primary Sponsor
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Freiburg
- Hugstetter Strasse 49
- 79095 Freiburg
- Germany
end of 1:1-Block address primary-sponsor

start of 1:1-Block address contact primary-sponsor
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.uniklinik-freiburg.de
end of 1:1-Block address contact primary-sponsor
Contact for Scientific Queries
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-contact

start of 1:1-Block address contact scientific-contact
- Telephone: +4976127032460
- Fax: +497612709633180
- E-mail: monika.engelhardt at uniklinik-freiburg.de
- URL: [---]*
end of 1:1-Block address contact scientific-contact
Contact for Public Queries
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-contact

start of 1:1-Block address contact public-contact
- Telephone: +4976127078171
- Fax: [---]*
- E-mail: mandy-deborah.moeller at uniklinik-freiburg.de
- URL: [---]*
end of 1:1-Block address contact public-contact

end of 1:n-Block addresses

start of 1:n-Block material support

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
start of 1:1-Block address materialSupport
- Universitätsklinikum Freiburg
- Hugstetter Strasse 49
- 79095 Freiburg
- Germany
end of 1:1-Block address materialSupport

start of 1:1-Block address contact materialSupport
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.uniklinik-freiburg.de
end of 1:1-Block address contact materialSupport

end of 1:n-Block material support

start of 1:1-Block state

Status

Recruitment Status: Recruiting planned
Study Closing (LPLV): [---]*

end of 1:1-Block state

start of 1:n-Block publications

Trial Publications, Results and other Documents

[---]*

end of 1:n-Block publications

* This entry means the parameter is not applicable or has not been set.