Stem Cell Transplant With Lenalidomide Maintenance in Pat... | NCT01109004

ID	Type	Description	Link
BMT CTN 0702	Other Identifier	Blood and Marrow Transplant Clinicial Trials Network
U01HL069294-05	U.S. NIH Grant/Contract		View source
690	Other Identifier	National Heart, Lung, and Blood Institute

Name	Class
Blood and Marrow Transplant Clinical Trials Network	NETWORK
National Cancer Institute (NCI)	NIH

Label	Type	Description	Intervention Names
Tandem auto transplant	Active Comparator	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance	Drug: Lenalidomide
RVD consolidation	Active Comparator	Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance	Drug: lenalidomide, bortezomib and dexamethasone
Lenalidomide maintenance	Active Comparator	Initial autologous transplant followed by lenalidomide maintenance	Drug: Lenalidomide

Name	Type	Description	Arm Group Labels	Other Names
Lenalidomide	Drug	All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Measure	Description	Time Frame
Percentage of Participants With Progression-free Survival (PFS)	Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.	38 months post-randomization

Measure	Description	Time Frame
Percentage of Participants With Disease Progression	Disease Progression is defined as progression of multiple myeloma, including one or more of the following: A reappearance of serum monoclonal paraprotein, with a level of at least 0.5 g/dL 24-hour urine protein electrophoresis with at least 200 mg paraprotein/24 hours Abnormal free light chain levels of >10 mg/dl, only in patients without measurable paraprotein in the serum and urine At least 10% plasma cells in a bone marrow aspirate or on trephine biopsy Definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of new bone lesions or soft tissue plasmacytomas Development of hypercalcemia (corrected serum Ca >11.5 mg/dL or >2.8 mmol/L) not attributable to any other cause To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating death prior to disease progression as a competing risk.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients meeting the criteria for symptomatic multiple myeloma (MM).
Patients who are 70 years of age, or younger, at time of enrollment.
Patients who have received at least two cycles of any regimen as initial systemic therapy and are within 2 - 12 months of the first dose of initial therapy.
Cardiac function: left ventricular ejection fraction at rest greater than 40 percent.
Hepatic: bilirubin less than 1.5x the upper limit of normal and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5x the upper limit of normal. (Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal.)
Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or calculated.
Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) greater than 50 percent of predicted value (corrected for hemoglobin).
Patients with an adequate autologous graft defined as a cryopreserved PBSC graft containing greater than or equal to 4 x 10^6 CD34+ cells/kg patient weight. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center. The autograft must be stored so that there are two products each containing at least 2 x 10^6 CD34+ cells/kg patient weight.
Signed informed consent form.

Exclusion Criteria:

Patients who never fulfill the criteria for symptomatic MM.
Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
Patients with plasma cell leukemia.
Karnofsky performance score less than 70 percent.
Patients with greater than grade 2 sensory neuropathy (CTCAE).
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
Patients seropositive for the human immunodeficiency virus (HIV).
Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
Patient has hypersensitivity to bortezomib, boron or mannitol.
Patient has received other investigational drugs with 14 days before enrollment.
Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent greater than 5 years previously is allowed.
Female patients who are pregnant (positive B-HCG) or breastfeeding.
Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
Prior allograft or prior autograft.
Patients who have received mid-intensity melphalan (greater than 50 mg IV) as part of prior therapy.
Patients unable or unwilling to provide informed consent.
Prior organ transplant requiring immunosuppressive therapy.
Patients with disease progression prior to enrollment.
Patients who have received lenalidomide as initial therapy for MM and have experienced toxicities resulting in treatment discontinuation.
Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide or thalidomide.
Patients unwilling to take deep vein thrombosis (DVT) prophylaxis.
Patients who cannot undergo an intervention in any treatment arm due to a priori denial of medical costs coverage by third party payers.
Patients unable to unwilling to return to the transplant center for their assigned treatments.

Name	Affiliation	Role
Mary Horowitz, MD	Center for International Blood and Marrow Transplant Research	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Cancer Center		Tucson	Arizona	85724	United States
City of Hope National Medical Center

PubMed Identifier	Type	Citation	Retractions
30653422	Result	Stadtmauer EA, Pasquini MC, Blackwell B, Hari P, Bashey A, Devine S, Efebera Y, Ganguly S, Gasparetto C, Geller N, Horowitz MM, Koreth J, Knust K, Landau H, Brunstein C, McCarthy P, Nelson C, Qazilbash MH, Shah N, Vesole DH, Vij R, Vogl DT, Giralt S, Somlo G, Krishnan A. Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial. J Clin Oncol. 2019 Mar 1;37(7):589-597. doi: 10.1200/JCO.18.00685. Epub 2019 Jan 17.
38701390

ID	Title	Description
FG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00056(28 to 70) BG00157(20 to 70) BG00256(30 to 70) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000100 BG001108 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Caucasian	BG000178 BG001192 BG002

Karnofsky Performance Score (KPS)

KPS describes patient-perceived global quality of life and functioning on a scale of 0-100.

100: No evidence of disease; 90: Normal activity. Minor signs or symptoms of disease; 80: Normal activity with effort. Some signs or symptoms of disease; 70: Cares for self. Unable to continue normal activity; 60: Needs occasional assistance, but cares for most personal needs; 50: Needs considerable assistance and medical care; 40: Disabled. Needs special care and assistance; 30: Severely disabled. Hospital admission indicated; 20: Very sick. Active supportive therapy needed; 10: Moribund; 0: Dead

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
90 or Greater	BG000182 BG001

Disease Risk

Participants on this study will be stratified for the purposes of statistical analysis into high-risk and standard risk-groups. High-risk multiple myeloma is defined by the presence of high beta-2 microglobulin (> 5.5mg/L) or the presence of cytogenetic abnormalities including t(4;14), t(14;20), t(14;16), deletion (17p) detected by FISH or standard cytogenetics, deletion 13 detected by standard cytogenetics only or aneuploidy. Participants without cytogenetic analysis available and beta-2 microglobulin ≤ 5.5mg/L or with deletion 13 detected by FISH will be classified as standard-risk disease.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Standard	BG000175 BG001

Initial Therapy

Initial therapy administered for the treatment of multiple myeloma

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Bortezomib/Lenalidomide/Dexamethasone	BG000141 BG001136 BG002

Time from Initial Therapy to Enrollment

Median

Full Range

months

Title

Denominators

Categories

Title	Measurements
	BG0005(2 to 14) BG0015(2 to 12) BG002

Number of Lines of Therapy

Lines of therapy is defined as the number of different regimens received prior to study entry.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
1	BG000210 BG001213 BG002

Disease Status at Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Stringent Complete Response	BG00021 BG00126 BG002

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

Percentage of Participants With Progression-free Survival (PFS)

Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.

Posted

Number

95% Confidence Interval

percentage of participants

38 months post-randomization

ID	Title	Description
OG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
OG001	RVD Consolidation	Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
OG002	Lenalidomide Maintenance	Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Units	Counts
Participants	OG000247 OG001254 OG002257

Title

Denominators

Categories

Title	Measurements
	OG00058.5(51.7 to 64.6) OG00157.8(51.4 to 63.7) OG00253.9(47.4 to 60.0)

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	The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.	Log Rank	The log rank test was stratified on risk status (high risk vs. standard risk)	0.87	The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.													Superiority

Secondary

Percentage of Participants With Disease Progression

Disease Progression is defined as progression of multiple myeloma, including one or more of the following:

A reappearance of serum monoclonal paraprotein, with a level of at least 0.5 g/dL
24-hour urine protein electrophoresis with at least 200 mg paraprotein/24 hours
Abnormal free light chain levels of >10 mg/dl, only in patients without measurable paraprotein in the serum and urine
At least 10% plasma cells in a bone marrow aspirate or on trephine biopsy
Definite increase in the size of existing bone lesions or soft tissue plasmacytomas
Development of new bone lesions or soft tissue plasmacytomas
Development of hypercalcemia (corrected serum Ca >11.5 mg/dL or >2.8 mmol/L) not attributable to any other cause

To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating death prior to disease progression as a competing risk.

Posted

Number

95% Confidence Interval

percentage of participants

38 months post-randomization

ID	Title	Description
OG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Secondary

Percentage of Participants With Overall Survival (OS)

Overall survival is defined as survival of death from any cause. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate overall survival at 38 months post-randomization.

Posted

Number

95% Confidence Interval

percentage of participants

38 months post-randomization

ID	Title	Description
OG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
OG001	RVD Consolidation	Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Secondary

Percentage of Participants With Treatment-related Mortality (TRM)

TRM is defined as death prior to progression of multiple myeloma. To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating disease progression as a competing risk.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 38 months post-randomization

ID	Title	Description
OG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
OG001	RVD Consolidation	Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Secondary

Number of Participants With Treatment Response

The number of participants with very good partial response (VGPR) or better [complete response (CR), near CR (nCR), and stringent CR (sCR)] according to the International Uniform Response Criteria will be calculated. The "Worse than VGPR" group includes PR, stable disease, and progressive disease.

sCR requires, in addition to CR: Normal free light chain ratio (FLC), Absence of clonal cells in bone marrow CR requires, in addition to nCR: Absence of the original monoclonal paraprotein (PPN), Disappearance of soft tissue plasmacytomas nCR is defined as: < 5% plasma cells in a bone marrow aspirate, No increase in lytic bone lesions VGPR requires: Serum or urine PPN not detectable on electrophoresis OR >=90% reduction in serum PPN plus urine PPN <100 mg/24hrs, >= 50% reduction in the level of serum monoclonal PPN or reduction in 24 hour urinary monoclonal PPN either >= 90% or to <200 mg/24 hours in light chain disease, >= 50% reduction in the size of soft tissue plasmacytomas

Only participants that were evaluable for disease response were analyzed at each time point. Those who had died or experienced disease progression were excluded.

Posted

Count of Participants

Participants

1 and 2 years post-randomization

ID	Title	Description
OG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Secondary

FACT-G Total Score

The Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life instrument that assesses the effects of cancer therapy on a patient's physical, social/family, emotional, and functional well-being. The assessment has 27 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-108, with higher scores indicating higher levels of overall well-being.

Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.

Posted

Mean

Standard Error

score on a scale

Up to 3 years post-randomization

ID	Title	Description
OG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
OG001	RVD Consolidation	Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Secondary

FACT-BMT Score

The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being.

Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.

Posted

Mean

Standard Error

score on a scale

Up to 3 years post-randomization

ID	Title	Description
OG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
OG001	RVD Consolidation

Secondary

FACT-BMT Trial Outcome Index

The Functional Assessment of Cancer Therapy (FACT) Trial Outcome Index is a quality of life instrument that assesses the impact of bone marrow transplantation (BMT) on a patient's physical and functional well-being while taking into consideration BMT-specific concerns. The assessment has 24 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-96, with higher scores indicating higher levels of overall well-being.

Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.

Posted

Mean

Standard Error

score on a scale

Up to 3 years post-randomization

ID	Title	Description
OG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
OG001	RVD Consolidation

Secondary

MOS SF-36 Physical Component Summary

The Medical Outcome Study (MOS) SF-36 Physical Component Summary is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.

Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.

Posted

Mean

Standard Deviation

score on a scale

Up to 3 years post-randomization

ID	Title	Description
OG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
OG001	RVD Consolidation	Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Secondary

MOS SF-36 Mental Component Summary

The Medical Outcome Study (MOS) SF-36 Mental Component Summary is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.

Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.

Posted

Mean

Standard Deviation

score on a scale

Up to 3 years post-randomization

ID	Title	Description
OG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
OG001	RVD Consolidation	Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Serious Adverse Events

Term	Organ System	Statistical Information
Haemolytic anaemia	Blood and lymphatic system disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Splenic infarction	Blood and lymphatic system disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Acute myocardial infarction	Cardiac disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Atrial fibrillation	Cardiac disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Bradycardia	Cardiac disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Cardiac failure congestive	Cardiac disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Cardiac tamponade	Cardiac disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Cardiac valve disease	Cardiac disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Cardio-respiratory arrest	Cardiac disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Left ventricular failure	Cardiac disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Myocardial infarction	Cardiac disorders	EG0002 events2 affected247 at risk EG0011 events1 affected254 at risk EG0021 events1 affected257 at risk
Sinus bradycardia	Cardiac disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Supraventricular tachycardia	Cardiac disorders	EG0001 events1 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Torsade de pointes	Cardiac disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Cataract	Eye disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Abdominal pain	Gastrointestinal disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Abdominal pain upper	Gastrointestinal disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Colitis ischaemic	Gastrointestinal disorders	EG0000 events0 affected247 at risk EG0012 events2 affected254 at risk EG0020 events0 affected257 at risk
Gastric haemorrhage	Gastrointestinal disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0022 events2 affected257 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0022 events2 affected257 at risk
Haemorrhoids	Gastrointestinal disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Impaired gastric emptying	Gastrointestinal disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Pancreatitis	Gastrointestinal disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0021 events1 affected257 at risk
Small intestinal obstruction	Gastrointestinal disorders	EG0002 events2 affected247 at risk EG0011 events1 affected254 at risk EG0024 events4 affected257 at risk
Bile duct stone	Hepatobiliary disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Cholecystitis	Hepatobiliary disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0023 events3 affected257 at risk
Cholecystitis acute	Hepatobiliary disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Appendicitis	Infections and infestations	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0022 events2 affected257 at risk
Gastroenteritis viral	Infections and infestations	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Fall	Injury, poisoning and procedural complications	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Fracture	Injury, poisoning and procedural complications	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Hip fracture	Injury, poisoning and procedural complications	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Subdural haematoma	Injury, poisoning and procedural complications	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0022 events2 affected257 at risk
Arthroscopy	Investigations	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Aspartate aminotransferase increased	Investigations	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Hepatic enzyme increased	Investigations	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Bone pain	Musculoskeletal and connective tissue disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected247 at risk EG0013 events3 affected254 at risk EG0020 events0 affected257 at risk
Acute promyelocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0021 events1 affected257 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0022 events2 affected257 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0002 events2 affected247 at risk EG0013 events3 affected254 at risk EG0020 events0 affected257 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0021 events1 affected257 at risk
Autonomic neuropathy	Nervous system disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Cerebral ischaemia	Nervous system disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Cerebral venous thrombosis	Nervous system disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Cerebrovascular accident	Nervous system disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Dizziness	Nervous system disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Haemorrhage intracranial	Nervous system disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Neuropathy peripheral	Nervous system disorders	EG0001 events1 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Spinal cord compression	Nervous system disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Syncope	Nervous system disorders	EG0001 events1 affected247 at risk EG0013 events3 affected254 at risk EG0020 events0 affected257 at risk
Mania	Psychiatric disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Mental status changes	Psychiatric disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0021 events1 affected257 at risk
Acute kidney injury	Renal and urinary disorders	EG0002 events2 affected247 at risk EG0010 events0 affected254 at risk EG0022 events2 affected257 at risk
Renal failure	Renal and urinary disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	EG0004 events4 affected247 at risk EG0011 events1 affected254 at risk EG0021 events1 affected257 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0024 events4 affected257 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0021 events1 affected257 at risk
Cataract operation	Surgical and medical procedures	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Cholecystectomy	Surgical and medical procedures	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Umbilical hernia repair	Surgical and medical procedures	EG0000 events0 affected247 at risk EG0010 events0 affected254 at risk EG0021 events1 affected257 at risk
Deep vein thrombosis	Vascular disorders	EG0002 events2 affected247 at risk EG0011 events1 affected254 at risk EG0021 events1 affected257 at risk
Hypotension	Vascular disorders	EG0001 events1 affected247 at risk EG0010 events0 affected254 at risk EG0020 events0 affected257 at risk
Superior vena cava syndrome	Vascular disorders	EG0000 events0 affected247 at risk EG0011 events1 affected254 at risk EG0020 events0 affected257 at risk

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
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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
D001897	Boronic Acids
D000148	Acids, Noncarboxylic
D000143	Acids
D007287	Inorganic Chemicals
D001896	Boron Compounds
D011719	Pyrazines
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D001190	Arylsulfonates
D017739	Arylsulfonic Acids
D013451	Sulfonic Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds

ID	Title	Description
BG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
BG001	RVD Consolidation	Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
BG002	Lenalidomide Maintenance	Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Tandem Auto Transplant	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.	42	247	247
EG001	RVD Consolidation	Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.	45	254	254
EG002	Lenalidomide Maintenance	Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.	53	257	257

ID	Term
D009101	Multiple Myeloma
D006402	Hematologic Diseases
D018450	Disease Progression

ID	Term
D000077269	Lenalidomide
D000069286	Bortezomib
D003907	Dexamethasone
D002123	Calcium Dobesilate