Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT00114101

Recruitment Status : Active, not recruiting

First Posted : June 14, 2005

Results First Posted : July 1, 2013

Last Update Posted : March 7, 2024

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Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Conditions	DS Stage I Multiple Myeloma DS Stage II Multiple Myeloma DS Stage III Multiple Myeloma Refractory Multiple Myeloma Smoldering Multiple Myeloma
Interventions	Procedure: Autologous Hematopoietic Stem Cell Transplantation Other: Laboratory Biomarker Analysis Drug: Lenalidomide Drug: Melphalan Procedure: Peripheral Blood Stem Cell Transplantation Other: Placebo Administration
Enrollment	460

Participant Flow

Recruitment Details	From December 2004 and July 2009, a total of 568 participants were recruited to this study.
Pre-assignment Details	After registration, participants underwent a peripheral blood stem cell transplant. Of the 568 participants, 460 were randomized to either arm, stratified by beta2 microglobulin, prior thalidomide use and prior lenalidomide use. (108 participants dropped out prior to randomization, most common reasons include: progression, ineligible, refusal)


Arm/Group Title	Lenalidomide Maintenance	Placebo Maintenance
Arm/Group Description	Beginning between day 100-110, pati...	Beginning between day 100-110, pati...
Arm/Group Description	Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.	Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
Period Title: Overall Study
Started	231	229
Completed	231	229
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Lenalidomide Maintenance	Placebo Maintenance	Total
Arm/Group Description		Beginning between day 100-110, pati...	Beginning between day 100-110, pati...	Total of all reporting groups
Arm/Group Description		Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.	Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)	Total of all reporting groups
Overall Number of Baseline Participants		231	229	460
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	231 participants	229 participants	460 participants
		59 (29 to 71)	58 (40 to 71)	59 (29 to 71)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	231 participants	229 participants	460 participants
	Female	110 47.6%	100 43.7%	210 45.7%
	Male	121 52.4%	129 56.3%	250 54.3%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	231 participants	229 participants	460 participants
United States		231	229	460
Beta 2 microglobulin at registration Measure Type: Number Unit of measure: Participants	Number Analyzed	231 participants	229 participants	460 participants
> 2.5 mg/liter		50	55	105
<= 2.5 mg/liter		170	163	333
Missing data		11	11	22
Prior use of thalidomide during induction Measure Type: Number Unit of measure: Participants	Number Analyzed	231 participants	229 participants	460 participants
Yes		102	103	205
No		129	126	255
Prior use of lenalidomide during induction therapy Measure Type: Number Unit of measure: Participants	Number Analyzed	231 participants	229 participants	460 participants
Yes		79	81	160
No		152	148	300

Outcome Measures

1.Primary Outcome


Title	Time to Progression
Description	Time to progression (TTP) was defined as the date of transplant to dat...
Description	Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progression was defined per the International Myeloma Working Group definition as one more of the following: 25% increase in serum M-component (absolute increase >= 0.5g/dl) 25% increase in urine M-component (absolute increase >= 200mg/24hour 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl) 25 % increase in bone marrow plasma cell percentage (absolute increase of >=10%) Definite development of new bone lesion or soft tissue plasmacytomas Development of hypercalcemia
Time Frame	Duration of study (up to 10years)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Lenalidomide Maintenance	Placebo Maintenance
Arm/Group Description:	Beginning between day 100-110, pati...	Beginning between day 100-110, pati...
Arm/Group Description:	Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.	Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
Overall Number of Participants Analyzed	231	229
Median (95% Confidence Interval) Unit of Measure: months
	39 ^[1] (36 to NA)	21 (18 to 28)

[1]

The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lenalidomide Maintenance, Placebo Maintenance
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	This study was designed to have 80% power, with the use of the log-rank test at a one-sided significance level of 0.05, to detect a hazard ratio of 1.4, assuming proportional hazards and an exponential time to event distribution. Under the assumed framework, 309 events were expected. The expected drop out rate before randomization was 15%.

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Participants were randomized with the use of a permuted-block design stratified by beta 2 microglobulin, prior use of thalidomide and prior use of lenalidomide. TTP was monitored with the use of a group sequential design for superiority and futility.
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.36
	Confidence Interval	(2-Sided) 95% 0.26 to 0.53
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
Description	Response was defined according to International Myeloma Working Group ...
Description	Response was defined according to International Myeloma Working Group criteria (2006) Complete Response: Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM) Partial Response: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels Marginal Response: 25-49% reduction in serum M-component & urine M-component by 50-89% which still exceeds 200mg/24hour Progressive Disease: Defined in primary outcome measure Stable Disease: Not meeting any of the criteria above
Time Frame	Day 100

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Lenalidomide Maintenance	Placebo Maintenance
Arm/Group Description:	Beginning between day 100-110, pati...	Beginning between day 100-110, pati...
Arm/Group Description:	Beginning between day 100-110, patients receive oral lenalidomide once daily.	Beginning between day 100-110, patients receive oral placebo once daily. (closed as of 12/17/09)
Overall Number of Participants Analyzed	231	229
Measure Type: Number Unit of Measure: participants
Complete response	67	79
Partial response	115	109
Marginal response	11	5
Stable disease	38	32
Progressive disease	0	3
Unknown	0	1

3.Other Pre-specified Outcome


Title	Overall Survival
Description	Overall Survival was measured from the date of randomization to date o...
Description	Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.
Time Frame	Duration of study (up to 10 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Lenalidomide Maintenance	Placebo Maintenance
Arm/Group Description:	Beginning between day 100-110, pati...	Beginning between day 100-110, pati...
Arm/Group Description:	Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.	Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
Overall Number of Participants Analyzed	231	229
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

The median overall survival has not been reached.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lenalidomide Maintenance, Placebo Maintenance
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.70
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 95% 0.26 to 1.02
	Estimation Comments	[Not Specified]

4.Post-Hoc Outcome


Title	Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy
Description	Patients who develop progression (defined in primary outcome measure),...
Description	Patients who develop progression (defined in primary outcome measure), died or develop a new primary malignancy (cancer) will summarized in this outcome.
Time Frame	Duration of study (up to 10 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Lenalidomide Maintenance	Placebo Maintenance
Arm/Group Description:	Beginning between day 100-110, pati...	Beginning between day 100-110, pati...
Arm/Group Description:	Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.	Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
Overall Number of Participants Analyzed	231	229
Measure Type: Number Unit of Measure: participants
	92	133

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lenalidomide Maintenance, Placebo Maintenance
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95% 0.41 to 0.69
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Lenalidomide Maintenance		Placebo Maintenance
Arm/Group Description	Beginning between day 100-110, pati...		Beginning between day 100-110, pati...
Arm/Group Description	Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.		Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
All-Cause Mortality
	Lenalidomide Maintenance		Placebo Maintenance
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Lenalidomide Maintenance		Placebo Maintenance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	52/231 (22.51%)		33/229 (14.41%)
Blood and lymphatic system disorders
Febrile neutropenia ^† 1	6/231 (2.60%)	6	2/229 (0.87%)	2
Hemoglobin ^† 1	8/231 (3.46%)	8	5/229 (2.18%)	5
Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis) ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Cardiac disorders
Cardiac Arrhythmia - Other ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Cardiac ischemia/infarction ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Conduction abnormality/atrioventricular heart block ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Left ventricular systolic dysfunction ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Restrictive cardiomyopathy ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Supraventricular and nodal arrhythmia ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Endocrine disorders
Thyroid function high (hyperthyroidism thyrotoxicosis) ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Thyroid function, low (hypothyroidism) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Eye disorders
Cataract ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Ocular/Visual - Other ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Gastrointestinal disorders
Constipation ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Diarrhea ^† 1	19/231 (8.23%)	22	9/229 (3.93%)	9
Distension/bloating, abdominal ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Esophagitis ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Gastrointestinal - Other ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Heartburn/dyspepsia ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Hemorrhage, GI ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Nausea ^† 1	5/231 (2.16%)	5	4/229 (1.75%)	4
Obstruction GI ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Pancreatitis ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Ulcer, GI ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Vomiting ^† 1	1/231 (0.43%)	1	3/229 (1.31%)	3
General disorders
Constitutional Symptoms - Other ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Death not associated with CTCAE term ^† 1	2/231 (0.87%)	2	2/229 (0.87%)	2
Edema: limb ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Fatigue (asthenia, lethargy, malaise) ^† 1	3/231 (1.30%)	3	2/229 (0.87%)	2
Fever ^† 1	3/231 (1.30%)	3	4/229 (1.75%)	4
Pain - Other ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Rigors/chills ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Hepatobiliary disorders
Liver dysfunction/failure (clinical) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Infection ^† 1	16/231 (6.93%)	18	7/229 (3.06%)	7
Infection - Other ^† 1	4/231 (1.73%)	4	1/229 (0.44%)	1
Infection with normal ANC or Grade 1 or 2 neutrophils ^† 1	14/231 (6.06%)	14	9/229 (3.93%)	13
Infection with unknown ANC ^† 1	0/231 (0.00%)	0	7/229 (3.06%)	8
Infection without neutropenia ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Injury, poisoning and procedural complications
Fracture ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Thrombosis/embolism (vascular access-related) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase) ^† 1	3/231 (1.30%)	3	1/229 (0.44%)	1
AST, SGOT(serum glutamic oxaloacetic transaminase) ^† 1	4/231 (1.73%)	4	1/229 (0.44%)	1
Alkaline phosphatase ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Bilirubin (hyperbilirubinemia) ^† 1	10/231 (4.33%)	12	4/229 (1.75%)	5
Cardiac troponin I (cTnI) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Creatinine ^† 1	1/231 (0.43%)	2	3/229 (1.31%)	3
Fibrinogen ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
INR (International Normalized Ratio of prothrombin time) ^† 1	2/231 (0.87%)	2	1/229 (0.44%)	1
Leukocytes (total WBC) ^† 1	10/231 (4.33%)	11	2/229 (0.87%)	2
Lipase ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Lymphopenia ^† 1	5/231 (2.16%)	5	3/229 (1.31%)	3
Metabolic/Laboratory - Other ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Neutrophils/granulocytes (ANC/AGC) ^† 1	40/231 (17.32%)	47	14/229 (6.11%)	16
PTT (Partial Thromboplastin Time) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Platelets ^† 1	39/231 (16.88%)	45	16/229 (6.99%)	21
Weight gain ^† 1	1/231 (0.43%)	1	3/229 (1.31%)	3
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Albumin, serum-low (hypoalbuminemia) ^† 1	2/231 (0.87%)	2	3/229 (1.31%)	3
Anorexia ^† 1	2/231 (0.87%)	2	1/229 (0.44%)	1
Calcium serum-high (hypercalcemia) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Calcium serum-low (hypocalcemia) ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Dehydration ^† 1	1/231 (0.43%)	1	4/229 (1.75%)	4
Glucose serum-high (hyperglycemia) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Glucose serum-low (hypoglycemia) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Magnesium serum-low (hypomagnesemia) ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Phosphate serum-low (hypophosphatemia) ^† 1	3/231 (1.30%)	4	3/229 (1.31%)	3
Potassium serum-high (hyperkalemia) ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Potassium serum-low (hypokalemia) ^† 1	3/231 (1.30%)	3	3/229 (1.31%)	3
Sodium serum-low (hyponatremia) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis) ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Pain ^† 1	6/231 (2.60%)	8	9/229 (3.93%)	12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Nervous system disorders
CNS cerebrovascular ischemia ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Dizziness ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Memory impairment ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Mental status ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Neurology - Other ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Neuropathy: motor ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Neuropathy: sensory ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Seizure ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Somnolence/depressed level of consciousness ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Syncope (fainting) ^† 1	2/231 (0.87%)	2	2/229 (0.87%)	2
Psychiatric disorders
Confusion ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Mood alteration ^† 1	4/231 (1.73%)	4	1/229 (0.44%)	1
Renal and urinary disorders
Renal failure ^† 1	1/231 (0.43%)	2	2/229 (0.87%)	3
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Cough ^† 1	3/231 (1.30%)	3	2/229 (0.87%)	2
Dyspnea (shortness of breath) ^† 1	3/231 (1.30%)	3	5/229 (2.18%)	5
Hypoxia ^† 1	3/231 (1.30%)	3	3/229 (1.31%)	4
Pneumonitis/pulmonary infiltrates ^† 1	3/231 (1.30%)	4	4/229 (1.75%)	5
Pulmonary/Upper Respiratory - Other ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Skin and subcutaneous tissue disorders
Pruritus/itching ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Rash/desquamation ^† 1	6/231 (2.60%)	6	4/229 (1.75%)	5
Rash: hand-foot skin reaction ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Vascular disorders
Hypertension ^† 1	0/231 (0.00%)	0	3/229 (1.31%)	3
Hypotension ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Thrombosis/thrombus/embolism ^† 1	2/231 (0.87%)	2	1/229 (0.44%)	1
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 6
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Lenalidomide Maintenance		Placebo Maintenance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	195/231 (84.42%)		166/229 (72.49%)
Blood and lymphatic system disorders
Blood/Bone Marrow - Other ^† 1	2/231 (0.87%)	4	1/229 (0.44%)	1
Febrile neutropenia ^† 1	9/231 (3.90%)	10	3/229 (1.31%)	4
Hemoglobin ^† 1	26/231 (11.26%)	45	9/229 (3.93%)	22
Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis) ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Cardiac disorders
Cardiac General - Other ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Conduction abnormality/atrioventricular heart block ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Edema ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Left ventricular systolic dysfunction ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Palpitations ^† 1	2/231 (0.87%)	2	1/229 (0.44%)	1
Supraventricular and nodal arrhythmia ^† 1	3/231 (1.30%)	3	1/229 (0.44%)	1
Ventricular arrhythmia ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	2
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Tinnitus ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Endocrine disorders
Thyroid function high (hyperthyroidism thyrotoxicosis) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Thyroid function, low (hypothyroidism) ^† 1	1/231 (0.43%)	2	2/229 (0.87%)	2
Eye disorders
Cataract ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Ocular/Visual - Other ^† 1	0/231 (0.00%)	0	4/229 (1.75%)	4
Vision-blurred vision ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	2
Watery eye (epiphora tearing) ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	3
Gastrointestinal disorders
Colitis ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Constipation ^† 1	9/231 (3.90%)	10	7/229 (3.06%)	12
Dental: periodontal disease ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Diarrhea ^† 1	89/231 (38.53%)	227	52/229 (22.71%)	90
Distension/bloating, abdominal ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Dry mouth/salivary gland (xerostomia) ^† 1	1/231 (0.43%)	2	3/229 (1.31%)	4
Dysphagia (difficulty swallowing) ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Esophagitis ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Gastritis (including bile reflux gastritis) ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Gastrointestinal - Other ^† 1	3/231 (1.30%)	3	1/229 (0.44%)	1
Heartburn/dyspepsia ^† 1	3/231 (1.30%)	3	0/229 (0.00%)	0
Hemorrhage, GI ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Hemorrhoids ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Melena/GI bleeding ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Mucositis/stomatitis (clinical exam) ^† 1	2/231 (0.87%)	2	1/229 (0.44%)	1
Mucositis/stomatitis (functional/symptomatic) ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Nausea ^† 1	13/231 (5.63%)	15	10/229 (4.37%)	15
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies if specified in the protocol. ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Vomiting ^† 1	9/231 (3.90%)	10	6/229 (2.62%)	9
General disorders
Constitutional Symptoms - Other ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Edema: limb ^† 1	4/231 (1.73%)	5	3/229 (1.31%)	3
Edema:head and neck ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Fatigue (asthenia, lethargy, malaise) ^† 1	36/231 (15.58%)	55	29/229 (12.66%)	54
Fever ^† 1	9/231 (3.90%)	10	2/229 (0.87%)	2
Flu-like syndrome ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Pain - Other ^† 1	1/231 (0.43%)	1	8/229 (3.49%)	14
Rigors/chills ^† 1	4/231 (1.73%)	6	1/229 (0.44%)	3
Syndromes - Other ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Hepatobiliary disorders
Cholecystitis ^† 1	2/231 (0.87%)	2	0/229 (0.00%)	0
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Allergy/Immunology - Other ^† 1	2/231 (0.87%)	2	0/229 (0.00%)	0
Infections and infestations
Infection ^† 1	16/231 (6.93%)	17	11/229 (4.80%)	14
Infection - Other ^† 1	6/231 (2.60%)	6	3/229 (1.31%)	3
Infection with normal ANC or Grade 1 or 2 neutrophils ^† 1	11/231 (4.76%)	14	14/229 (6.11%)	18
Infection with unknown ANC ^† 1	15/231 (6.49%)	18	9/229 (3.93%)	11
Infection without neutropenia ^† 1	2/231 (0.87%)	3	1/229 (0.44%)	1
Opportunistic infection associated with >=Grade 2 Lymphopenia ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Viral hepatitis ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Burn ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Fracture ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Intra-operative injury ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase) ^† 1	11/231 (4.76%)	13	2/229 (0.87%)	3
AST, SGOT(serum glutamic oxaloacetic transaminase) ^† 1	7/231 (3.03%)	8	3/229 (1.31%)	5
Alkaline phosphatase ^† 1	5/231 (2.16%)	5	4/229 (1.75%)	4
Bilirubin (hyperbilirubinemia) ^† 1	24/231 (10.39%)	66	18/229 (7.86%)	36
CPK (creatine phosphokinase) ^† 1	1/231 (0.43%)	3	0/229 (0.00%)	0
Creatinine ^† 1	2/231 (0.87%)	2	5/229 (2.18%)	9
GGT (gamma-Glutamyl transpeptidase) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
INR (International Normalized Ratio of prothrombin time) ^† 1	3/231 (1.30%)	7	0/229 (0.00%)	0
Leukocytes (total WBC) ^† 1	29/231 (12.55%)	72	14/229 (6.11%)	33
Lymphopenia ^† 1	17/231 (7.36%)	31	9/229 (3.93%)	23
Metabolic/Laboratory - Other ^† 1	2/231 (0.87%)	3	3/229 (1.31%)	4
Neutrophils/granulocytes (ANC/AGC) ^† 1	153/231 (66.23%)	593	75/229 (32.75%)	181
PTT (Partial Thromboplastin Time) ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Platelets ^† 1	129/231 (55.84%)	445	78/229 (34.06%)	200
Weight gain ^† 1	13/231 (5.63%)	21	21/229 (9.17%)	33
Weight loss ^† 1	1/231 (0.43%)	2	1/229 (0.44%)	1
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia) ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Anorexia ^† 1	5/231 (2.16%)	5	6/229 (2.62%)	7
Calcium serum-high (hypercalcemia) ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	3
Calcium serum-low (hypocalcemia) ^† 1	6/231 (2.60%)	6	5/229 (2.18%)	6
Dehydration ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Glucose serum-high (hyperglycemia) ^† 1	8/231 (3.46%)	12	7/229 (3.06%)	18
Glucose serum-low (hypoglycemia) ^† 1	3/231 (1.30%)	3	1/229 (0.44%)	2
Phosphate serum-low (hypophosphatemia) ^† 1	2/231 (0.87%)	2	3/229 (1.31%)	4
Potassium serum-high (hyperkalemia) ^† 1	3/231 (1.30%)	3	1/229 (0.44%)	1
Potassium serum-low (hypokalemia) ^† 1	9/231 (3.90%)	11	4/229 (1.75%)	7
Sodium serum-low (hyponatremia) ^† 1	2/231 (0.87%)	2	1/229 (0.44%)	1
Triglyceride serum-high (hypertriglyceridemia) ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Uric acid serum-high (hyperuricemia) ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Musculoskeletal and connective tissue disorders
Arthritis (non-septic) ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Joint-function ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Lumbar spine-range of motion ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	2
Muscle weakness, generalized or specific area (not due to neuropathy) ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	3
Musculoskeletal/Soft Tissue - Other ^† 1	0/231 (0.00%)	0	4/229 (1.75%)	4
Myositis (inflammation/damage of muscle) ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Pain ^† 1	35/231 (15.15%)	84	50/229 (21.83%)	154
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment ^† 1	5/231 (2.16%)	5	1/229 (0.44%)	1
Nervous system disorders
Ataxia (incoordination) ^† 1	2/231 (0.87%)	3	0/229 (0.00%)	0
Dizziness ^† 1	4/231 (1.73%)	8	8/229 (3.49%)	9
Headache ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Hemorrhage CNS ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Memory impairment ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Neurology - Other ^† 1	1/231 (0.43%)	1	4/229 (1.75%)	4
Neuropathy: cranial ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Neuropathy: motor ^† 1	6/231 (2.60%)	10	4/229 (1.75%)	6
Neuropathy: sensory ^† 1	24/231 (10.39%)	40	24/229 (10.48%)	49
Somnolence/depressed level of consciousness ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Speech impairment (e.g., dysphasia or aphasia) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Syncope (fainting) ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Taste alteration (dysgeusia) ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Tremor ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Psychiatric disorders
Insomnia ^† 1	6/231 (2.60%)	6	7/229 (3.06%)	15
Libido ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Mood alteration ^† 1	9/231 (3.90%)	12	11/229 (4.80%)	16
Renal and urinary disorders
Hemorrhage GU ^† 1	1/231 (0.43%)	1	2/229 (0.87%)	2
Renal failure ^† 1	3/231 (1.30%)	3	3/229 (1.31%)	3
Renal/Genitourinary - Other ^† 1	1/231 (0.43%)	1	3/229 (1.31%)	3
Urinary frequency/urgency ^† 1	2/231 (0.87%)	3	4/229 (1.75%)	4
Urinary retention (including neurogenic bladder) ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Reproductive system and breast disorders
Vaginal discharge (non-infectious) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Allergic rhinitis (including sneezing nasal stuffiness postnasal drip) ^† 1	2/231 (0.87%)	2	4/229 (1.75%)	7
Apnea ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Bronchospasm wheezing ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Cough ^† 1	10/231 (4.33%)	12	9/229 (3.93%)	13
Dyspnea (shortness of breath) ^† 1	4/231 (1.73%)	5	4/229 (1.75%)	8
Hemorrhage pulmonary/upper respiratory ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Hypoxia ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Pleural effusion (non-malignant) ^† 1	1/231 (0.43%)	1	1/229 (0.44%)	1
Pneumonitis/pulmonary infiltrates ^† 1	8/231 (3.46%)	8	11/229 (4.80%)	12
Pulmonary/Upper Respiratory - Other ^† 1	3/231 (1.30%)	3	5/229 (2.18%)	5
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other ^† 1	2/231 (0.87%)	2	0/229 (0.00%)	0
Dry skin ^† 1	6/231 (2.60%)	8	4/229 (1.75%)	5
Hair loss/alopecia (scalp or body) ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	2
Pruritus/itching ^† 1	5/231 (2.16%)	5	3/229 (1.31%)	4
Rash/desquamation ^† 1	57/231 (24.68%)	86	36/229 (15.72%)	56
Sweating (diaphoresis) ^† 1	4/231 (1.73%)	6	4/229 (1.75%)	5
Ulceration ^† 1	1/231 (0.43%)	1	0/229 (0.00%)	0
Urticaria (hives welts wheals) ^† 1	0/231 (0.00%)	0	2/229 (0.87%)	2
Vascular disorders
Hematoma ^† 1	2/231 (0.87%)	2	0/229 (0.00%)	0
Hemorrhage/Bleeding - Other ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	1
Hot flashes/flushes ^† 1	3/231 (1.30%)	4	0/229 (0.00%)	0
Hypertension ^† 1	2/231 (0.87%)	2	2/229 (0.87%)	2
Hypotension ^† 1	0/231 (0.00%)	0	1/229 (0.44%)	2
Thrombosis/thrombus/embolism ^† 1	5/231 (2.16%)	5	0/229 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 6

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Philip McCarthy, MD
Organization:	Roswell Park Cancer Institute
EMail:	philip.mccarthy@roswellpark.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Holstein SA, Jung SH, Richardson PG, Hofmeister CC, Hurd DD, Hassoun H, Giralt S, Stadtmauer EA, Weisdorf DJ, Vij R, Moreb JS, Callander NS, van Besien K, Gentile TG, Isola L, Maziarz RT, Bashey A, Landau H, Martin T, Qazilbash MH, Rodriguez C, McClune B, Schlossman RL, Smith SE, Hars V, Owzar K, Jiang C, Boyd M, Schultz C, Wilson M, Hari P, Pasquini MC, Horowitz MM, Shea TC, Devine SM, Linker C, Anderson KC, McCarthy PL. Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial. Lancet Haematol. 2017 Sep;4(9):e431-e442. doi: 10.1016/S2352-3026(17)30140-0. Epub 2017 Aug 17. Erratum In: Lancet Haematol. 2018 Aug;5(8):e332. Lancet Haematol. 2018 Dec;5(12):e608.

McCarthy PL, Owzar K, Hofmeister CC, Hurd DD, Hassoun H, Richardson PG, Giralt S, Stadtmauer EA, Weisdorf DJ, Vij R, Moreb JS, Callander NS, Van Besien K, Gentile T, Isola L, Maziarz RT, Gabriel DA, Bashey A, Landau H, Martin T, Qazilbash MH, Levitan D, McClune B, Schlossman R, Hars V, Postiglione J, Jiang C, Bennett E, Barry S, Bressler L, Kelly M, Seiler M, Rosenbaum C, Hari P, Pasquini MC, Horowitz MM, Shea TC, Devine SM, Anderson KC, Linker C. Lenalidomide after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1770-81. doi: 10.1056/NEJMoa1114083.

Layout table for additonal information

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00114101
Other Study ID Numbers:	NCI-2009-00439 NCI-2009-00439 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CALGB 100104/ECOG 100104 CDR0000434845 CALGB-100104 ( Other Identifier: Alliance for Clinical Trials in Oncology ) CALGB-100104 ( Other Identifier: CTEP ) U10CA180821 ( U.S. NIH Grant/Contract ) U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted:	June 13, 2005
First Posted:	June 14, 2005
Results First Submitted:	March 28, 2013
Results First Posted:	July 1, 2013
Last Update Posted:	March 7, 2024

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