Multiple MyelomaNCT00577096

Effects of Exercise in Combination With Epoetin Alfa

A study testing Epoetin Alfa, Exercise and Autologous Peripheral Blood Stem Cell Transplantation in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Multiple Myeloma
What is being tested?: Epoetin Alfa, Exercise and Autologous Peripheral Blood Stem Cell Transplantation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: Oct 2001to Jun 2004
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Those who were not at high risk for impending pathologic fracture or cord compression, as determined by magnetic resonance imaging and other radiology reports and physician assessments,and enrolled in Total Therapy treatment protocols were invited to participate in the study.

Who cannot join

Patients were excluded if they showed any of the following attributes/conditions:
Inability to understand the intent of the study
Current diagnosis with a major psychiatric illness
Presence of microcytic or macrocytic anemia
Uncontrolled hypertension
Red cell transfusions within 2 weeks; and
Recombinant epoetin alfa within 8 weeks of study enrollment.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma

The purpose of the study was to determine the effect of Epoetin alfa therapy (short term versus long term) with and without a home-based individualized exercise program that incorporated aerobic and strength resistance training for patients being treated with high-dose chemotherapy and autologous peripheral bloodstem cell transplantation (PBSC T) for multiple myeloma. The endpoints for the study included the number of attempts at and total number of days of stem cell collection, number of RBC and platelet transfusions during the transplantation period, time-to-recovery after transplantation, and response to intensive therapy for multiple myeloma.

Conditions: Multiple Myeloma
Being tested: Epoetin Alfa, Exercise, Autologous Peripheral Blood Stem Cell Transplantation, Red Blood Cell Transfusion, Thalidomide
Keywords: multiple myeloma, polysomnography, quality of life, exercise
Medical subject headings: Multiple Myeloma, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epoetin AlfaDrug
Also called EPO
Epoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual dose is 150 units/kg og body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl.
ExerciseBehavioural
A home-based individualized exercise program that incorporated aerobic and strength resistance training.
Autologous Peripheral Blood Stem Cell TransplantationBiological
Also called (PBSCT)
Standard PBSCT for multiple myeloma
Red Blood Cell TransfusionBiological
Also called (RBC)
RBC Transfusion was administered as needed
ThalidomideDrug
Fifty percent of the participants received 400 mg daily
Heparin, Low-Molecular-WeightDrug
Patients who received thalidomide also received prophylactic low molecular weight heparin
Platelet TransfusionBiological
Platelet transfusions were administered as needed
MelphalanDrug
Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
Epoetin AlfaDrug
Also called EPO
Epoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual 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
Total Therapy IIDrug
Also called vincristine, doxorubicin, dexamethasone, cyclophosphamide
Standard Induction chemotherapy care included: vincristine, doxorubicin, and dexamethasone (VAD) (0.5 mg, 10 mg/m2, and 40 mg, respectively);dexamethasone, cyclophosphamide,etoposide, and cisplatin (DCEP) (40 mg, 400 mg/m2, 40 mg/m2, and 15 mg/m2,respectively); and cyclophosphamide,doxorubicin, and dexamethasone (CAD) (750 mg/m2, 15 mg/m2, and 40 mg, respectively) for mobilization.
Red Blood Cell TransfusionBiological
Also called RBC
RBC Transfusion was administered as needed
ThalidomideDrug
Fifty percent of participants received 400 mg daily
Heparin, Low-Molecular-WeightDrug
Patients who received thalidomide also received prophylactic low molecular weight heparin
Platelet TransfusionBiological
Platelet transfusions were administered as needed
MelphalanDrug
Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma

Study groups in NCT00577096
Study group	Role	What they receive
Exercise	Experimental	Study participants were computer randomized to an individualized exercise program. Participants were stratified within Arm according to whether or not they received thalidomide with heparin, and by age (60 and younger versus older than 60) Receives: Drug: Epoetin Alfa; Behavioral: Exercise; Biological: Autologous Peripheral Blood Stem Cell Transplantation; Biological: Red Blood Cell Transfusion; Drug: Thalidomide; Drug: Heparin, Low-Molecular-Weight; Biological: Platelet Transfusion; Drug: Melphalan
usual care	Active comparator	Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified within Arm according to whether or not they received thalidomide with heparin, and by age (60 and younger versus older than 60) Receives: Drug: Epoetin Alfa; Drug: Total Therapy II; Biological: Red Blood Cell Transfusion; Drug: Thalidomide; Drug: Heparin, Low-Molecular-Weight; Biological: Platelet Transfusion; Drug: Melphalan

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
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.
Measured: up to 15 weeks
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
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.
Measured: up to 30 weeks
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
Measured: up to 15 weeks
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
Measured: up to 30 weeks
Number of Stem Cell Collection Attempts (Short Term)
Measured: up to 15 weeks
Number of Stem Cell Collection Attempts (Long Term)
Measured: up to 30 weeks
Total Number of Days of Stem Cell Collection (Short Term)
Measured: up to 15 weeks
Total Number of Days of Stem Cell Collection (Long Term)
Measured: up to 30 weeks

Secondary outcomes (2)

Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.
Measured: up to 15 weeks
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.
Measured: up to 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2001Jun 2004

First posted19 Dec 2007 (estimated)
Study startOct 2001
Primary completionJun 2004
Study completionJun 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by University of ArkansasThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00577096
Sponsor's protocol ID: IRB # 29287
Other IDs: R01NR008937, Ortho Biotech Clinical Affairs
Status last verified: Apr 2015
First submitted: 17 Dec 2007
Last updated: 6 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
ClinicalTrials.gov ID: NCT00577096
Acronym / sponsor ID: IRB # 29287
Conditions: Multiple Myeloma
Keywords: multiple myeloma, polysomnography, quality of life, exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University of ArkansasUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), Ortho Biotech Clinical Affairs, L.L.C.
Study start: Oct 2001
Primary completion: Jun 2004 (actual)
Study completion: Jun 2004 (actual)
First posted: 19 Dec 2007 (estimated)
Results: Posted 21 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Exercise	Experimental	Drug: Epoetin Alfa, Behavioral: Exercise, Biological: Autologous Peripheral Blood Stem Cell Transplantation, Biological: Red Blood Cell Transfusion, Drug: Thalidomide, Drug: Heparin, Low-Molecular-Weight, Biological: Platelet Transfusion, Drug: MelphalanStudy participants were computer randomized to an individualized exercise program. Participants were stratified within Arm according to whether or not they received thalidomide with heparin, and by age (60 and younger versus older than 60)
usual care	Active comparator	Drug: Epoetin Alfa, Drug: Total Therapy II, Biological: Red Blood Cell Transfusion, Drug: Thalidomide, Drug: Heparin, Low-Molecular-Weight, Biological: Platelet Transfusion, Drug: MelphalanStudy participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified within Arm according to whether or not they received thalidomide with heparin, and by age (60 and younger versus older than 60)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Those who were not at high risk for impending pathologic fracture or cord compression, as determined by magnetic resonance imaging and other radiology reports and physician assessments,and enrolled in Total Therapy treatment protocols were invited to participate in the study.

Key exclusion criteria (7 listed)

Inability to understand the intent of the study
Current diagnosis with a major psychiatric illness
Presence of microcytic or macrocytic anemia
Uncontrolled hypertension
Red cell transfusions within 2 weeks; and

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Epoetin AlfaAlso: EPOEpoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual dose is 150 units/kg og body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl.	Drug	Exercise
ExerciseA home-based individualized exercise program that incorporated aerobic and strength resistance training.	Behavioural	Exercise
Autologous Peripheral Blood Stem Cell TransplantationAlso: (PBSCT)Standard PBSCT for multiple myeloma	Biological	Exercise
Red Blood Cell TransfusionAlso: (RBC)RBC Transfusion was administered as needed	Biological	Exercise
ThalidomideFifty percent of the participants received 400 mg daily	Drug	Exercise
Heparin, Low-Molecular-WeightPatients who received thalidomide also received prophylactic low molecular weight heparin	Drug	Exercise
Platelet TransfusionPlatelet transfusions were administered as needed	Biological	Exercise
MelphalanAdministered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma	Drug	Exercise
Epoetin AlfaAlso: EPOEpoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual 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	Drug	usual care
Total Therapy IIAlso: vincristine, doxorubicin, dexamethasone, cyclophosphamideStandard Induction chemotherapy care included: vincristine, doxorubicin, and dexamethasone (VAD) (0.5 mg, 10 mg/m2, and 40 mg, respectively);dexamethasone, cyclophosphamide,etoposide, and cisplatin (DCEP) (40 mg, 400 mg/m2, 40 mg/m2, and 15 mg/m2,respectively); and cyclophosphamide,doxorubicin, and dexamethasone (CAD) (750 mg/m2, 15 mg/m2, and 40 mg, respectively) for mobilization.	Drug	usual care
Red Blood Cell TransfusionAlso: RBCRBC Transfusion was administered as needed	Biological	usual care
ThalidomideFifty percent of participants received 400 mg daily	Drug	usual care
Heparin, Low-Molecular-WeightPatients who received thalidomide also received prophylactic low molecular weight heparin	Drug	usual care
Platelet TransfusionPlatelet transfusions were administered as needed	Biological	usual care
MelphalanAdministered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma	Drug	usual care

Primary outcome

Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
Time frame: up to 15 weeks
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.
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
Time frame: up to 30 weeks
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.
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
Time frame: up to 15 weeks
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
Time frame: up to 30 weeks
Number of Stem Cell Collection Attempts (Short Term)
Time frame: up to 15 weeks
Number of Stem Cell Collection Attempts (Long Term)
Time frame: up to 30 weeks
Total Number of Days of Stem Cell Collection (Short Term)
Time frame: up to 15 weeks
Total Number of Days of Stem Cell Collection (Long Term)
Time frame: up to 30 weeks

2 secondary outcomes

Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
Time frame: up to 15 weeks
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
Time frame: up to 30 weeks

Results and safety

Results posted to the registry on 21 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	69	62
Exercise	66	58

Primary outcome: Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)

Time frame: up to 15 weeks. Mean (Standard Deviation). Unit: RBC Transfusions

Measure	Usual Care n = 28	Exercise n = 23
Value	2.3 (2.5)	1.8 (2.2)

Usual Care vs Exercise: p <0.025, ANOVA

Population analysed: 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).

Primary outcome: Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)

Time frame: up to 30 weeks. Mean (Standard Deviation). Unit: RBC Transfusions

Measure	Usual Care n = 34	Exercise n = 35
Value	1.8 (2.9)	1.0 (1.3)

Usual Care vs Exercise: p <0.025, ANOVA

Primary outcome: Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)

Time frame: up to 15 weeks. Mean (Standard Deviation). Unit: Platelet transfusions

Measure	Usual Care n = 28	Exercise n = 23
Value	3.1 (3.2)	2.3 (1.6)

Usual Care vs Exercise: p <0.025, ANOVA

Primary outcome: Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)

Time frame: up to 30 weeks. Mean (Standard Deviation). Unit: Platelet Transfusions

Measure	Usual Care n = 34	Exercise n = 35
Value	3.6 (4.5)	2.0 (2.0)

Usual Care vs Exercise: p <0.025, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 30 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	17 of 62 (27.4%)	0 of 0	Not reported
Exercise	25 of 58 (43.1%)	0 of 0	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sharon K Coon study director

University of Oklahoma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Epoetin Alfa, Exercise and Autologous Peripheral Blood Stem Cell Transplantation in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term) (time frame: up to 15 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00577096.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.