Strength Training in Improving Quality of Life in Patients With Multiple Myeloma

PRIMARY OBJECTIVES:

I. To assess the feasibility of a 6 month, twice weekly supervised strength training or a
control intervention in patients with multiple myeloma.

SECONDARY OBJECTIVES:

I. To assess the adherence rate of the two groups (supervised strength training versus
control) during the 6 month intervention programs.

II. To assess the eligibility and recruitment rate for the trial among patients with multiple
myeloma.

EXPLORATORY OBJECTIVES:

I. Comparison of disease activity parameters, physical activity level, clinical symptoms,
medication, psycho-oncological parameters, body composition and immune status between the
intervention and control group.

II. Determine factors that may influence a persons? willingness to participate in the trial.

III. Compare the bone density (acquired by dual energy x-ray absorptiometry [DEXA] scan)
before and after intervention.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients complete strength training over 1 hour twice weekly for 6 months.

ARM II: Patients receive standard of care.

After completion of study, patients are followed up for 1 year.

Inclusion Criteria:

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1

- Have a diagnosis of multiple myeloma

- Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would
put them in danger when participating in the study according to the physician?s
discretion

- Are able to understand and follow assessment and training procedures

- Participant or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

- Current and symptomatic pathological fracture(s) or severely advanced instability of
the musculo-skeletal system

- Acute bone instability as assessed by whole body low-dose computed tomography and
evaluated by an experienced neuro- and spine surgeon

- Major comorbidities that would cause danger to the patient when participating in the
study. Examples are cardiac or pulmonary and infectious diseases that would have a
risk of progression if the patient took part in the study

- Unwilling or unable to follow protocol requirements

- Any condition which in the investigator?s opinion deems the participant an unsuitable
candidate to take part in study intervention (comorbidities, myeloma symptoms,
treatment side effects)