Methods |
Randomisation
Recruitment period
Median follow‐up time
Sample size calculation
|
Participants |
Eligibility criteria
New diagnosis of multiple myeloma
Eligible for tandem autologous peripheral‐blood stem cell transplantation
No risk for pathologic fractures or spinal cord compression
Participants (N = 187)
Mean age
Stage of disease
Therapy
Intervention group: 69% Total Therapy II, 31% Total Therapy III; 36% no thalidomide, 64% thalidomide
Control group: 75% Total Therapy II, 25% Total Therapy III; 43% no thalidomide, 57% thalidomide
Country
|
Interventions |
Exercise group
Aerobic exercise: walking to tolerance (until tired)
Stretching: performed daily for various muscles
Strength resistance training on alternate days with stretch bands.
Control group
All participants received high‐dose therapy and tandem transplantation (Total Therapy II or Total Therapy III). 50% of those receiving Total Therapy II were randomised to receive thalidomide during induction, after transplantation consolidation, and maintenance therapy. All Total Therapy III participants (62) received thalidomide. EPO administered to first 102 study participants (investigational algorithm) that allowed haemoglobin levels to reach 15 g/dL before dose reduction or delay, and started before chemotherapy unless baseline haemoglobin was < 15 g/dL, differing from recommended haemoglobin parameters for EPO administration to participants who are receiving chemotherapy outside of a clinical trial setting.
Duration of short‐term study was 15 weeks. The first 70 participants who met eligibility for long‐term participation (i.e. response to EPO) continued in the study for an additional 15 weeks, which included administration of DCEP, melphalan and the first peripheral‐blood stem cell transplantation
|
Outcomes |
Reported and analysed in this review
Fatigue
6‐minute walk test
Adverse events
Reported but not relevant for this review
Response to intensive treatment protocol for multiple myeloma
Time to recovery after transplantation
Haemoglobin levels
Number of red blood cell‐ and platelet transfusions
Number of attempts at and total days of stem cell collection
|
Notes |
Conflict of interest not reported, funding not reported |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Not reported |
Allocation concealment (selection bias) |
Unclear risk |
Not reported |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Blinding in this context is not feasible |
Blinding of outcome assessor (primary endpoint; mortality) |
Low risk |
Outcome not reported. The review authors judge that the outcome mortality in this unblinded trial is unlikely to be influenced by lack of blinding |
Blinding of outcome assessor (patient‐reported outcomes) |
High risk |
Blinding in this context is not feasible |
Blinding of outcome assessor (physical performance, AEs, SAEs) |
Unclear risk |
Not reported |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
15 participants who dropped out were not analysed |
Selective reporting (reporting bias) |
Low risk |
All outcomes mentioned in the protocol are reported |
Other bias |
High risk |
50% of participants received thalidomide. In the study analysis this drug administration was not considered and no subgroup data were provided for participants receiving or not receiving thalidomide |