A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Vers... | NCT00097981

ID	Type	Description	Link
DO04-23-006	Other Identifier	Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Name	Class
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA	INDUSTRY

Label	Type	Description	Intervention Names
Thalidomide + dexamethasone	Active Comparator		Drug: Thalidomide Drug: Dexamethasone
Thalidomide + dexamethasone + DOXIL	Experimental		Drug: Thalidomide Drug: Dexamethasone Drug: DOXIL

Name	Type	Description	Arm Group Labels	Other Names
Thalidomide	Drug	Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.

Measure	Description	Time Frame
Complete Response Rate: Number of Participants Who Achieved a Complete Response	Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.	From Cycle 2 until 28 days following completion of treatment

Measure	Description	Time Frame
Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)	Overall response to study medication is defined as number of participants who acheived a complete response (CR) or partial response (PR) by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

ID	Title	Description
FG000	Thalidomide + Dexamethasone	Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Complete Response Rate: Number of Participants Who Achieved a Complete Response

Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.

Intent-to-treat: Participants who were randomized to receive the treatment.

Posted

Number

Participants

From Cycle 2 until 28 days following completion of treatment

ID	Title	Description
OG000	Thalidomide + Dexamethasone	Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
OG001	DOXIL + Thalidomide + Dexamethasone	DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

Units	Counts
Participants	OG000113 OG001112

Title

Denominators

Categories

Title	Measurements
	OG0005 OG0018

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	Stratified by International Prognostic Index (IPI) stage 1,2 and 3	0.49														Superiority or Other

Secondary

Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)

Overall response to study medication is defined as number of participants who acheived a complete response (CR) or partial response (PR) by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.

Intent-to-treat: Participants who were randomized to receive the treatment.

Posted

Number

Participants

From Cycle 2 until 28 days following completion of treatment

ID	Title	Description
OG000	Thalidomide + Dexamethasone	Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
OG001	DOXIL + Thalidomide + Dexamethasone	DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

Secondary

Time to 1st Response

Time to first response was defined as the interval from date of randomization to date of achieving a partial response (PR) or better according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.

Intent-to-treat: Participants who were randomized to receive the treatment.

Posted

Median

95% Confidence Interval

Days

From Cycle 2 until 28 days following completion of treatment

ID	Title	Description
OG000	Thalidomide + Dexamethasone	Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
OG001	DOXIL + Thalidomide + Dexamethasone	DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

Secondary

Time to Progression

Time to progression is the interval between the date of randomization until disease progression or death due to progression.

Intent-to-treat: Participants who were randomized to receive the treatment.

Posted

Median

95% Confidence Interval

Days

From randomization until death or as assessed up to 2 years post last participant last treatment visit

ID	Title	Description
OG000	Thalidomide + Dexamethasone	Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
OG001	DOXIL + Thalidomide + Dexamethasone	DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

Secondary

Overall Survival: Number of Participants Died Due to Any Cause

Intent-to-treat: Participants who were randomized to receive the treatment.

Posted

Number

Participants

From randomization until death or as assessed up to 2 years post last participant last treatment visit

ID	Title	Description
OG000	Thalidomide + Dexamethasone	Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
OG001	DOXIL + Thalidomide + Dexamethasone	DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

Units	Counts

Secondary

Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)

Intent-to-treat: Participants who were randomized to receive the treatment.

Posted

Number

Participants

From randomization until death or as assessed up to 2 years post last participant last treatment visit

ID	Title	Description
OG000	Thalidomide + Dexamethasone	Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
OG001	DOXIL + Thalidomide + Dexamethasone	DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

Units

Secondary

Engraftment: Number of Participants Who Underwent Engraftment

Engraftment is the process of transplanted stem cells reproducing new cells.

Intent-to-treat: Participants who were randomized to receive the treatment and who underwent transplantation.

Posted

Number

Participants

From randomization until death or as assessed up to 2 years post last participant last treatment visit

ID	Title	Description
OG000	Thalidomide + Dexamethasone	Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
OG001	DOXIL + Thalidomide + Dexamethasone	DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0002 affected110 at risk EG0013 affected106 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0012 affected106 at risk
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0011 affected106 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0012 affected106 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0012 affected106 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Angina Pectoris	Cardiac disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0011 affected106 at risk
Arrhythmia	Cardiac disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0003 affected110 at risk EG0013 affected106 at risk
Bundle Branch Block Right	Cardiac disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Cardiac Arrest	Cardiac disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0013 affected106 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Myocardial Infarction	Cardiac disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0002 affected110 at risk EG0011 affected106 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0013 affected106 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Duodenal Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0012 affected106 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Ileus	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0011 affected106 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Tongue Disorder	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Asthenia	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0003 affected110 at risk EG0013 affected106 at risk
Chest Pain	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Chills	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Disease Progression	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Fatigue	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0011 affected106 at risk
Mass	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Mucosal Inflammation	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Oedema	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Oedema Peripheral	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Pyrexia	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0014 affected106 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Abscess	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Appendicitis	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Bacteraemia	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0012 affected106 at risk
Bacterial Infection	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Catheter Related Infection	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Cellulitis	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Diverticulitis	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Endocarditis Enterococcal	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Fungal Infection	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Infection	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Oesophageal Candidiasis	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Pneumonia	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0005 affected110 at risk EG0017 affected106 at risk
Pneumonia Pneumococcal	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Pneumonia Staphylococcal	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Sepsis	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0003 affected110 at risk EG0012 affected106 at risk
Staphylococcal Infection	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Urosepsis	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Accidental Overdose	Injury, poisoning and procedural complications	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Compression Fracture	Injury, poisoning and procedural complications	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Ejection Fraction Decreased	Investigations	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
International Normalised Ratio Increased	Investigations	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0011 affected106 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0004 affected110 at risk EG0013 affected106 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0007 affected110 at risk EG0011 affected106 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0011 affected106 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0011 affected106 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0011 affected106 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0011 affected106 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0002 affected110 at risk EG0011 affected106 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Joint Effusion	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Myopathy Steroid	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0011 affected106 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Multiple Myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Grand Mal Convulsion	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Hemiparesis	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Sleep Apnoea Syndrome	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Syncope	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0004 affected110 at risk EG0015 affected106 at risk
Tremor	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Anxiety	Psychiatric disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Polyuria	Renal and urinary disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Renal Failure	Renal and urinary disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0005 affected110 at risk EG0013 affected106 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0012 affected106 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Acute Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Chronic Obstructive Airways Disease Exacerbated	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Cryptogenic Organising Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0002 affected110 at risk EG0011 affected106 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0012 affected106 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0006 affected110 at risk EG0014 affected106 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0013 affected106 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Stevens-Johnson Syndrome	Skin and subcutaneous tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Arthrectomy	Surgical and medical procedures	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0005 affected110 at risk EG0014 affected106 at risk
Haematoma	Vascular disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Haemorrhage	Vascular disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Hypertension	Vascular disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0002 affected110 at risk EG0011 affected106 at risk
Hypotension	Vascular disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0002 affected110 at risk EG0011 affected106 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0001 affected110 at risk EG0010 affected106 at risk
Shock	Vascular disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk
Thrombophlebitis	Vascular disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0000 affected110 at risk EG0011 affected106 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00021 affected110 at risk EG00131 affected106 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0006 affected110 at risk EG0012 affected106 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0004 affected110 at risk EG00121 affected106 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0006 affected110 at risk EG0011 affected106 at risk
Cushingoid	Endocrine disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0005 affected110 at risk EG0017 affected106 at risk
Vision Blurred	Eye disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0009 affected110 at risk EG00116 affected106 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0004 affected110 at risk EG0016 affected106 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00045 affected110 at risk EG00148 affected106 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00015 affected110 at risk EG00116 affected106 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0003 affected110 at risk EG0017 affected106 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00010 affected110 at risk EG0016 affected106 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0003 affected110 at risk EG0017 affected106 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0005 affected110 at risk EG0018 affected106 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00026 affected110 at risk EG00139 affected106 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0004 affected110 at risk EG00114 affected106 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00013 affected110 at risk EG00115 affected106 at risk
Asthenia	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00019 affected110 at risk EG00113 affected106 at risk
Fatigue	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00058 affected110 at risk EG00158 affected106 at risk
Mucosal Inflammation	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0004 affected110 at risk EG00120 affected106 at risk
Oedema	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00012 affected110 at risk EG00116 affected106 at risk
Oedema Peripheral	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00053 affected110 at risk EG00160 affected106 at risk
Pyrexia	General disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00014 affected110 at risk EG00116 affected106 at risk
Candidiasis	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0003 affected110 at risk EG0019 affected106 at risk
Oral Candidiasis	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0002 affected110 at risk EG0017 affected106 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 8.1	Non-systematic Assessment	EG0009 affected110 at risk EG00114 affected106 at risk
International Normalised Ratio Increased	Investigations	MedDRA Version 8.1	Non-systematic Assessment	EG0007 affected110 at risk EG0018 affected106 at risk
Weight Decreased	Investigations	MedDRA Version 8.1	Non-systematic Assessment	EG0009 affected110 at risk EG0019 affected106 at risk
Weight Increased	Investigations	MedDRA Version 8.1	Non-systematic Assessment	EG0007 affected110 at risk EG0015 affected106 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00012 affected110 at risk EG00116 affected106 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0009 affected110 at risk EG00110 affected106 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00010 affected110 at risk EG00110 affected106 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0007 affected110 at risk EG0014 affected106 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00019 affected110 at risk EG00118 affected106 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00010 affected110 at risk EG00110 affected106 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00013 affected110 at risk EG00111 affected106 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0006 affected110 at risk EG0014 affected106 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00016 affected110 at risk EG00115 affected106 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00016 affected110 at risk EG00116 affected106 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0005 affected110 at risk EG0019 affected106 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0003 affected110 at risk EG0016 affected106 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0009 affected110 at risk EG0014 affected106 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00012 affected110 at risk EG00110 affected106 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0009 affected110 at risk EG0014 affected106 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0009 affected110 at risk EG0016 affected106 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00014 affected110 at risk EG00113 affected106 at risk
Dizziness	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00027 affected110 at risk EG00123 affected106 at risk
Dysgeusia	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00010 affected110 at risk EG00116 affected106 at risk
Headache	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00018 affected110 at risk EG0014 affected106 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00016 affected110 at risk EG00114 affected106 at risk
Neuropathy	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00013 affected110 at risk EG00115 affected106 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00022 affected110 at risk EG00117 affected106 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00016 affected110 at risk EG00113 affected106 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00014 affected110 at risk EG00112 affected106 at risk
Somnolence	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00013 affected110 at risk EG0012 affected106 at risk
Tremor	Nervous system disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00020 affected110 at risk EG00122 affected106 at risk
Anxiety	Psychiatric disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00016 affected110 at risk EG00116 affected106 at risk
Confusional State	Psychiatric disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0008 affected110 at risk EG0014 affected106 at risk
Depression	Psychiatric disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00015 affected110 at risk EG00115 affected106 at risk
Insomnia	Psychiatric disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00024 affected110 at risk EG00116 affected106 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00011 affected110 at risk EG00110 affected106 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00022 affected110 at risk EG00124 affected106 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0005 affected110 at risk EG0016 affected106 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0003 affected110 at risk EG0016 affected106 at risk
Pharyngolaryngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0005 affected110 at risk EG0018 affected106 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0003 affected110 at risk EG0017 affected106 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0003 affected110 at risk EG00111 affected106 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0007 affected110 at risk EG0017 affected106 at risk
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0003 affected110 at risk EG00139 affected106 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 8.1	Non-systematic Assessment	EG00020 affected110 at risk EG00120 affected106 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0004 affected110 at risk EG00110 affected106 at risk
Hypertension	Vascular disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0002 affected110 at risk EG0019 affected106 at risk
Hypotension	Vascular disorders	MedDRA Version 8.1	Non-systematic Assessment	EG0005 affected110 at risk EG0016 affected106 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Fountain Valley	California		United States

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Title	Description
BG000	Thalidomide + Dexamethasone	Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
BG001	DOXIL + Thalidomide + Dexamethasone	DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Thalidomide + Dexamethasone	Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.			48	110	110	110
EG001	DOXIL + Thalidomide + Dexamethasone	DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.			53	106	104	106

ID	Term
D013792	Thalidomide
D003907	Dexamethasone
C506643	liposomal doxorubicin