Trial Outcomes & Findings for Effects of Exercise in Combination With Epoetin Alfa (NCT NCT00577096)

Last Updated: 2015-04-06

Results Overview

The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

up to 15 weeks

Results posted on

2015-04-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Short Term Participation STARTED	69	66
Short Term Participation COMPLETED	62	58
Short Term Participation NOT COMPLETED	7	8
Long Term Participation STARTED	34	35
Long Term Participation COMPLETED	34	35
Long Term Participation NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Short Term Participation withdrew from multiple myeloma treatment	3	2
Short Term Participation Withdrawal by Subject	3	5
Short Term Participation Death	1	1

Baseline Characteristics

Effects of Exercise in Combination With Epoetin Alfa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=69 Participants 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 n=66 Participants 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 n=135 Participants Total of all reporting groups
Age, Continuous Short Term Participants	58 years STANDARD_DEVIATION 9.2 • n=5 Participants	54.5 years STANDARD_DEVIATION 10.4 • n=7 Participants	55 years STANDARD_DEVIATION 10 • n=5 Participants
Age, Continuous Long Term Participants	54.4 years STANDARD_DEVIATION 9.7 • n=5 Participants	55.4 years STANDARD_DEVIATION 11.4 • n=7 Participants	55 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex/Gender, Customized Male (short term study)	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants
Sex/Gender, Customized Female (short term study)	22 participants n=5 Participants	19 participants n=7 Participants	41 participants n=5 Participants
Sex/Gender, Customized Male (long term study)	24 participants n=5 Participants	23 participants n=7 Participants	47 participants n=5 Participants
Sex/Gender, Customized Female (long term study)	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Caucasian (short term study)	31 participants n=5 Participants	27 participants n=7 Participants	58 participants n=5 Participants
Race/Ethnicity, Customized Other (short term study)	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Race/Ethnicity, Customized Caucasian (long term study)	32 participants n=5 Participants	31 participants n=7 Participants	63 participants n=5 Participants
Race/Ethnicity, Customized Other (long term study)	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	66 participants n=7 Participants	135 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 15 weeks

Population: For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).

Outcome measures

Outcome measures
Measure	Usual Care n=28 Participants 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 n=23 Participants 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.
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)	2.3 RBC Transfusions Standard Deviation 2.5	1.8 RBC Transfusions Standard Deviation 2.2

PRIMARY outcome

Timeframe: up to 30 weeks

Outcome measures

Outcome measures
Measure	Usual Care n=34 Participants 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 n=35 Participants 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.
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)	1.8 RBC Transfusions Standard Deviation 2.9	1.0 RBC Transfusions Standard Deviation 1.3

PRIMARY outcome

Timeframe: up to 15 weeks

Outcome measures

Outcome measures
Measure	Usual Care n=28 Participants 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 n=23 Participants 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.
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)	3.1 Platelet transfusions Standard Deviation 3.2	2.3 Platelet transfusions Standard Deviation 1.6

PRIMARY outcome

Timeframe: up to 30 weeks

Outcome measures

Outcome measures
Measure	Usual Care n=34 Participants 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 n=35 Participants 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.
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)	3.6 Platelet Transfusions Standard Deviation 4.5	2.0 Platelet Transfusions Standard Deviation 2.0

PRIMARY outcome

Timeframe: up to 15 weeks

Outcome measures

Outcome measures
Measure	Usual Care n=28 Participants 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 n=23 Participants 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.
Number of Stem Cell Collection Attempts (Short Term)	1.4 Stem Cell Collection Attempts Standard Deviation 0.8	1.1 Stem Cell Collection Attempts Standard Deviation 0.3

PRIMARY outcome

Timeframe: up to 30 weeks

Outcome measures

Outcome measures
Measure	Usual Care n=34 Participants 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 n=35 Participants 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.
Number of Stem Cell Collection Attempts (Long Term)	1.3 Stem Cell Collection Attempts Standard Deviation 0.6	1.1 Stem Cell Collection Attempts Standard Deviation 0.4

PRIMARY outcome

Timeframe: up to 15 weeks

Outcome measures

Outcome measures
Measure	Usual Care n=28 Participants 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 n=23 Participants 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 Number of Days of Stem Cell Collection (Short Term)	5.3 Days Standard Deviation 4.0	4.0 Days Standard Deviation 2.3

PRIMARY outcome

Timeframe: up to 30 weeks

Outcome measures

Outcome measures
Measure	Usual Care n=34 Participants 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 n=35 Participants 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 Number of Days of Stem Cell Collection (Long Term)	4.9 Days Standard Deviation 3.1	4.5 Days Standard Deviation 3.1

SECONDARY outcome

Timeframe: up to 15 weeks

Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.

Outcome measures

Outcome measures
Measure	Usual Care n=28 Participants 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 n=23 Participants 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.
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term) Baseline	12.1 g/dl Standard Deviation 1.6	11.6 g/dl Standard Deviation 1.7
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term) Before transplantation	10.8 g/dl Standard Deviation 1.5	11.0 g/dl Standard Deviation 1.6
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term) During transplantation	10.1 g/dl Standard Deviation 0.7	10.4 g/dl Standard Deviation 0.9
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term) At discharge	10.6 g/dl Standard Deviation 1.4	10.6 g/dl Standard Deviation 1.1

SECONDARY outcome

Timeframe: up to 30 weeks

Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.

Outcome measures

Outcome measures
Measure	Usual Care n=34 Participants 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 n=35 Participants 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.
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term) Baseline	11.5 g/dl Standard Deviation 1.8	11.7 g/dl Standard Deviation 1.8
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term) Before Transplantation	12.0 g/dl Standard Deviation 1.6	12.0 g/dl Standard Deviation 1.4
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term) During Transplanation	10.8 g/dl Standard Deviation 1.1	10.8 g/dl Standard Deviation 1.1
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term) At Discharge	10.9 g/dl Standard Deviation 1.4	11.0 g/dl Standard Deviation 1.3

Adverse Events

Usual Care

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Exercise

Serious events: 25 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Ann Coleman

University of Arkansas for Medical Sciences

Phone: 501-661-7902

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Usual Care n=62 participants at risk 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 n=58 participants at risk 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.
Blood and lymphatic system disorders Anemia	1.6% 1/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	1.7% 1/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Cardiac disorders Atrial fibrillation	0.00% 0/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	1.7% 1/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Musculoskeletal and connective tissue disorders Compression fracture	0.00% 0/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	1.7% 1/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
General disorders Death	1.6% 1/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	1.7% 1/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Vascular disorders Deep Vein Thrombosis (DVT)	17.7% 11/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	17.2% 10/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
General disorders Dehydration	3.2% 2/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	1.7% 1/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
General disorders Fluid overload	1.6% 1/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	0.00% 0/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Metabolism and nutrition disorders Hyperglycemia	4.8% 3/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	5.2% 3/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Blood and lymphatic system disorders Hyponatremia	1.6% 1/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	8.6% 5/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Infections and infestations Infection / sepsis	8.1% 5/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	1.7% 1/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Gastrointestinal disorders Mucositis / diarrhea	1.6% 1/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	1.7% 1/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Cardiac disorders Myocardial infarction	0.00% 0/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	1.7% 1/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Immune system disorders Neutropenic fever	17.7% 11/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	13.8% 8/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
General disorders Pain	1.6% 1/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	1.7% 1/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Infections and infestations Pneumonia	8.1% 5/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	1.7% 1/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Vascular disorders Pulmonary embolus	4.8% 3/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	3.4% 2/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Infections and infestations Rectal abcesses	1.6% 1/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	0.00% 0/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Renal and urinary disorders Renal failure	1.6% 1/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	0.00% 0/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Renal and urinary disorders Renal stone	1.6% 1/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	0.00% 0/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.6% 1/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	0.00% 0/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
Gastrointestinal disorders Ruptured diverticulum	0.00% 0/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	1.7% 1/58 • Number of events 59 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
General disorders Syncope	1.6% 1/62 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.	0.00% 0/58 • up to 30 weeks All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.