Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Behaviors and Mental Disorders

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Analgesics

Fibrinolytic Agents

Anticoagulants

Anti-Infective Agents

Hematinics

Bone Density Conservation Agents

Etoposide

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Dexamethasone

Chrysarobin

Vincristine

Melphalan

Heparin

Cisplatin

Dexamethasone acetate

Etoposide phosphate

Thalidomide

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Epoetin Alfa

Calcium

Calcium, Dietary

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

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)

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)

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.

A home-based individualized exercise program that incorporated aerobic and strength resistance training.

Exercise

Autologous Peripheral Blood Stem Cell Transplantation

RBC Transfusion was administered as needed

Red Blood Cell Transfusion

Fifty percent of the participants received 400 mg daily

Patients who received thalidomide also received prophylactic low molecular weight heparin

Platelet transfusions were administered as needed

Platelet Transfusion

Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma

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

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.

Total Therapy II

Fifty percent of participants received 400 mg daily

Sharon K Coon

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.

Effects of Exercise in Combination With Epoetin Alfa

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

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.

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

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

National Institutes of Health (NIH)

Ortho Biotech Clinical Affairs, L.L.C.

University of Arkansas

Elizabeth Ann Coleman, PhD, RNP, AOCN

All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.

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

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 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

Short Term Participants

Long Term Participants

Age, Continuous

Male (short term study)

Female (short term study)

Male (long term study)

Female (long term study)

Sex/Gender, Customized

Caucasian (short term study)

Other (short term study)

Caucasian (long term study)

Other (long term study)

Race/Ethnicity, Customized

United States

Region of Enrollment

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.

Elizabeth Ann Coleman

The null hypothesis was that there would be no difference between groups for the number of RBC transfusions.

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).

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

The null hypothesis is that there was no difference in the number of RBC tranfusions in the exercise versus usual care groups. Data was combined from the short and long term RBC transfusions.

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

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

The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.

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

Number of Stem Cell Collection Attempts (Short Term)

The null hypothesis was that there would be no difference between groups for the number of stem cell collection attempts.

Number of Stem Cell Collection Attempts (Long Term)

The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.

Total Number of Days of Stem Cell Collection (Short Term)

Total Number of Days of Stem Cell Collection (Long Term)

Baseline

Before transplantation

During transplantation

At discharge

Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)

Before Transplantation

During Transplanation

At Discharge

Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)

Short Term Participation

Long Term Participation

Symptoms and General Pathology

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Sclerosis

Parasomnias

Tuberous Sclerosis

Sleep Wake Disorders

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Hamartoma

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Tuberous Sclerosis Complex

Questionnaires electroencephalogram (EEG) Actigraphy polysomnography

* Epworth sleepiness scale
* Pittsburgh sleep quality Index (PSQI)
* EQ-5D Adults
* Pediatric Daytime Sleepiness scale (PDSS)
* Sleep disturbance Scale for Children (SDSC
* EQ-5D Children
* Sleaping diary

Questionnaires

is an electrophysiological monitoring method to record electrical activity of the brain

electroencephalogram (EEG)

type of sleep study, is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine

polysomnography

type of sleep study based on bracelet around the wrist

Actigraphy

Veerle Van Mossevelde, Study coordinator

Dirk De Clippeleir, Study coordinator

Veerle Van Mossevelde, Datanurse

Anna Jansen, PhD, MD

Sonia De Weerdt, MD

Alessandra Pereira,, PhD, MD

Magda Nunes, PhD, MD

Oliviero Bruni, PhD, MD

Paolo Curatolo, PhD, MD

The proposed research project is aimed at further characterization of sleep problems and evaluation of their impact in children and adults with TSC, excluding epilepsy as contributing factor. Questionnaire-based studies have shown that sleep problems occur in up to half of the children and a third of adults with tuberous sclerosis complex (TSC). However, there is only limited information on the nature of sleep problems and their impact on patients with TSC and their families.

Questionnaire-based studies have shown that sleep problems occur in up to half of the children and a third of adults with tuberous sclerosis complex (TSC). However, there is only limited information on the nature of sleep problems and their impact on patients with TSC and their families. It is known from a questionnaire-based study in children with TSC that they often wake early or wake frequently during the night, and that they can be more tired during the day. In some children, sleep-problems seem to be related to the presence of seizures during the night. This has been confirmed in a study on 10 children with TSC and epilepsy by a combination of polysomnography (sleep study) and electroencephalography (EEG). A questionnaire-based study in adults also revealed the association with epilepsy features, and showed influence of mental health complaints on sleep.

Sleep structure and quality will be assessed through formal sleep studies (polysomnography and actigraphy). The influence of abnormal brain activity on sleep will be mapped by simultaneous recording of brain activity by means of EEG. The impact of sleep disorders will be determined through interviews with individuals with TSC and their relatives. The investigators will also use questionnaires and diaries to supplement their findings.

Importance: It is expected that the results of this study will 1) improve our understanding of sleep problems in TSC, 2) provide additional information on the influence of TSC on sleep, 3) give a more in-depth view on the impact of sleep problems on the lives of individuals with TSC and their families, 4) increase awareness about sleep problems in TSC, and 5) contribute to a better management of sleep problems by patients and families.

2 groups:

* 30 Children(0-18y) withTSC without epilepsy
* 30 Adults(\>18y) withTSC without epilepsy

Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)

- Sleep efficiency (SE%): the percentage ratio between total sleep time and time in bed (TST/TIB\*100)

Universitair Ziekenhuis Brussel

Study coordinator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Exercise in Combination With Epoetin Alfa	NCT00577096	Multiple Myelom...	Epoetin Alfa Exercise Autologous Peri... Red Blood Cell ... Thalidomide Heparin, Low-Mo... Platelet Transf... Melphalan Epoetin Alfa Total Therapy I... Red Blood Cell ... Thalidomide Heparin, Low-Mo... Platelet Transf... Melphalan	-	University of Arkansas
Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)	NCT03326765	Sleep Disorder	Questionnaires electroencephal... polysomnography Actigraphy	1 Day - 70 Years	Universitair Ziekenhuis Brussel
Effects of Exercise in Combination With Epoetin Alfa	NCT00577096	Multiple Myelom...	Epoetin Alfa Exercise Autologous Peri... Red Blood Cell ... Thalidomide Heparin, Low-Mo... Platelet Transf... Melphalan Epoetin Alfa Total Therapy I... Red Blood Cell ... Thalidomide Heparin, Low-Mo... Platelet Transf... Melphalan	-	University of Arkansas

Spots Global Cancer Trial Database for polysomnography