Effects of Exercise in Combination With Epoetin Alfa

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study conducted at multiple myeloma international referral center included patients newly diagnosed & eligible for treatment with aggressive treatment. Protocol included tandem peripheral blood stem cell transplants.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Usual Care	Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
Exercise	Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.

Participant Flow for 2 periods

Period 1:   Short Term Participation

	Usual Care	Exercise
STARTED	69	66
COMPLETED	62	58
NOT COMPLETED	7	8
withdrew from multiple myeloma treatment	3	2
Withdrawal by Subject	3	5
Death	1	1

Period 2:   Long Term Participation

	Usual Care	Exercise
STARTED	34 [1]	35 [2]
COMPLETED	34	35 [3]
NOT COMPLETED	0	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Usual Care	Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
Exercise	Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
Total	Total of all reporting groups

Baseline Measures

	Usual Care	Exercise	Total
Overall Participants Analyzed  [Units: Participants]	69	66	135
Age  [Units: Years] Mean (Standard Deviation)
Short Term Participants	58  (9.2)	54.5  (10.4)	55  (10)
Long Term Participants	54.4  (9.7)	55.4  (11.4)	55  (10.6)
Gender, Customized  [Units: Participants]
Male (short term study)	13	12	25
Female (short term study)	22	19	41
Male (long term study)	24	23	47
Female (long term study)	10	12	22
Race/Ethnicity, Customized  [Units: Participants]
Caucasian (short term study)	31	27	58
Other (short term study)	4	4	8
Caucasian (long term study)	32	31	63
Other (long term study)	2	4	6
Region of Enrollment  [Units: Participants]
United States	69	66	135

1.  Primary:

Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)   [ Time Frame: up to 15 weeks ]

2.  Primary:

Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)   [ Time Frame: up to 30 weeks ]

3.  Primary:

Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)   [ Time Frame: up to 15 weeks ]

4.  Primary:

Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)   [ Time Frame: up to 30 weeks ]

5.  Primary:

Number of Stem Cell Collection Attempts (Short Term)   [ Time Frame: up to 15 weeks ]

6.  Primary:

Number of Stem Cell Collection Attempts (Long Term)   [ Time Frame: up to 30 weeks ]

7.  Primary:

Total Number of Days of Stem Cell Collection (Short Term)   [ Time Frame: up to 15 weeks ]

8.  Primary:

Total Number of Days of Stem Cell Collection (Long Term)   [ Time Frame: up to 30 weeks ]

9.  Secondary:

Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)   [ Time Frame: up to 15 weeks ]

10.  Secondary:

Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)   [ Time Frame: up to 30 weeks ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Patients with hemoglobin <8 g/dl received RBC transfusions according to the transplantation protocol. Analysis may have missed specific disease-related influences on hemoglobin. Randomization should have distributed disease risks equally for groups.