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Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01169337
Recruitment Status : Active, not recruiting
First Posted : July 26, 2010
Results First Posted : May 18, 2021
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Light Chain Deposition Disease
Smoldering Plasma Cell Myeloma
Interventions Other: Clinical Observation
Drug: Lenalidomide
Enrollment 226
Recruitment Details Between January 2011 and January 2013, 44 patients were enrolled in the phase II safety run in portion of the study and were treated with lenalidomide as a single agent. Between February 2013 and July 2017, 182 patients were randomly assigned between the two treatment arms in the phase III portion of the study.
Pre-assignment Details  
Arm/Group Title Arm A (Lenalidomide; Phase II) Arm A (Lenalidomide; Phase III) Arm B (Observation; Phase III)
Hide Arm/Group Description Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo observation until progression to symptomatic myeloma.
Period Title: Overall Study
Started 44 90 92
Received Treatment/Observation 44 88 86
Completed 0 0 86
Not Completed 44 90 6
Reason Not Completed
Lack of Efficacy             5             7             0
Adverse Event             12             18             0
Death             2             0             0
Withdrawal by Subject             11             11             6
Noncompliance             2             0             0
Other complicating disease             1             1             0
Physician Decision             1             5             0
Alternative therapy             0             2             0
Changed hospital             0             1             0
Never started treatment             0             2             0
Reason not reported             1             0             0
Continuing lenalidomide             9             43             0
Arm/Group Title Arm A (Lenalidomide; Phase II) Arm A (Lenalidomide; Phase III) Arm B (Observation; Phase III) Total
Hide Arm/Group Description Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo observation until progression to symptomatic myeloma. Total of all reporting groups
Overall Number of Baseline Participants 44 90 92 226
Hide Baseline Analysis Population Description
All registered patients in phase II portion and randomized patients in phase III portion
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants 90 participants 92 participants 226 participants
62
(36 to 83)
63
(31 to 82)
64
(33 to 96)
64
(31 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 90 participants 92 participants 226 participants
Female
24
  54.5%
48
  53.3%
46
  50.0%
118
  52.2%
Male
20
  45.5%
42
  46.7%
46
  50.0%
108
  47.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 90 participants 92 participants 226 participants
Hispanic or Latino
0
   0.0%
2
   2.2%
4
   4.3%
6
   2.7%
Not Hispanic or Latino
43
  97.7%
81
  90.0%
81
  88.0%
205
  90.7%
Unknown or Not Reported
1
   2.3%
7
   7.8%
7
   7.6%
15
   6.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 90 participants 92 participants 226 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.1%
1
   1.1%
2
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  13.6%
12
  13.3%
19
  20.7%
37
  16.4%
White
37
  84.1%
72
  80.0%
68
  73.9%
177
  78.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.3%
5
   5.6%
4
   4.3%
10
   4.4%
1.Primary Outcome
Title Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint)
Hide Description Proportion of patients with grade 3 adverse events that effect vital organ function (such as cardiac, hepatic or thromboembolic) or any grade 4 or higher non-hematologic adverse events
Time Frame Assessed every 4 weeks while on treatment up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The first 36 patients in the phase II part as planned in the study design
Arm/Group Title Arm A (Lenalidomide; Phase II)
Hide Arm/Group Description:
Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 36
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
0.056
(0.010 to 0.165)
2.Primary Outcome
Title 2-year Progression-free Survival (PFS) Rate (Phase III Primary Endpoint)
Hide Description

PFS is defined as time from randomization to progression or death, whichever occurs first. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year PFS rate.

  1. Any of the following:

    • Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression"
    • Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression"
    • Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%)
  2. Any of the following felt related to the underlying clonal plasma cell proliferative disorder:

    • Hypercalcemia (> 11 mg/dL)
    • Decrease in hemoglobin of ≥ 2 gms/dL
    • Serum creatinine level ≥ 2mg/dL
    • Development of myeloma bone lesions or soft tissue plasmacytoma
Time Frame Assessed every 3 months for 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Arm A (Lenalidomide; Phase III) Arm B (Observation; Phase III)
Hide Arm/Group Description:
Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo observation until progression to symptomatic myeloma.
Overall Number of Participants Analyzed 90 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.93
(0.88 to 0.99)
0.76
(0.66 to 0.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Lenalidomide; Phase III), Arm B (Observation; Phase III)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Log Rank
Comments stratified 1-sided log-rank test
3.Secondary Outcome
Title Proportion of Participants With Response (Phase II Secondary Endpoint)
Hide Description

Response is defined as complete response (CR), very good partial response (VGPR) or partial response (PR).

CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-component plus urine M-component < 100 mg per 24 hours

PR:

  • ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours
  • If followed by free light chain (FLC) only, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels
  • If unmeasurable disease by serum M-protein, urine M-protein, and serum FLC at baseline, a ≥50% reduction in plasma cells provided baseline bone marrow percentage was ≥ 30%
  • If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas
Time Frame Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10
Hide Outcome Measure Data
Hide Analysis Population Description
All registered patients in the phase II part
Arm/Group Title Arm A (Lenalidomide; Phase II)
Hide Arm/Group Description:
Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.477
(0.325 to 0.633)
4.Secondary Outcome
Title Proportion of Participants With Response (Phase III Secondary Endpoint)
Hide Description

Response is defined as complete response (CR), very good partial response (VGPR) or partial response (PR).

CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-component plus urine M-component < 100 mg per 24 hours

PR:

  • ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours
  • If followed by free light chain (FLC) only, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels
  • If unmeasurable disease by serum M-protein, urine M-protein, and serum FLC at baseline, a ≥50% reduction in plasma cells provided baseline bone marrow percentage was ≥ 30%
  • If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas
Time Frame Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10
Hide Outcome Measure Data
Hide Analysis Population Description
Among randomized patients who received treatment or observation
Arm/Group Title Arm A (Lenalidomide; Phase III) Arm B (Observation; Phase III)
Hide Arm/Group Description:
Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo observation until progression to symptomatic myeloma.
Overall Number of Participants Analyzed 88 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.50
(0.391 to 0.608)
0
(0 to 0.042)
5.Secondary Outcome
Title 1-year Progression-free Survival (PFS) Rate (Phase III Secondary Endpoint)
Hide Description

PFS is defined as time from randomization to progression or death, whichever occurs first. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 1-year PFS rate.

  1. Any of the following:

    • Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression"
    • Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression"
    • Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%)
  2. Any of the following felt related to the underlying clonal plasma cell proliferative disorder:

    • Hypercalcemia (> 11 mg/dL)
    • Decrease in hemoglobin of ≥ 2 gms/dL
    • Serum creatinine level ≥ 2mg/dL
    • Development of myeloma bone lesions or soft tissue plasmacytoma
Time Frame Assessed every 3 months for one year
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Arm A (Lenalidomide; Phase III) Arm B (Observation; Phase III)
Hide Arm/Group Description:
Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo observation until progression to symptomatic myeloma.
Overall Number of Participants Analyzed 90 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.98
(0.95 to 1.00)
0.89
(0.82 to 0.96)
6.Secondary Outcome
Title 2-year Progression-free Rate (Phase III Secondary Endpoint)
Hide Description

TTP is defined as the time from randomization to progression. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year progression-free rate.

  1. Any of the following:

    • Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression"
    • Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression"
    • Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%)
  2. Any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder:

    • Hypercalcemia (> 11 mg/dL)
    • Decrease in hemoglobin of ≥ 2 gms/dL
    • Serum creatinine level ≥ 2mg/dL
    • Development of myeloma bone lesions or soft tissue plasmacytoma
Time Frame Assessed every 3 months for 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients in the phase III part of the study
Arm/Group Title Arm A (Lenalidomide; Phase III) Arm B (Observation; Phase III)
Hide Arm/Group Description:
Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo observation until progression to symptomatic myeloma.
Overall Number of Participants Analyzed 90 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
94.3
(85.4 to 97.9)
75.8
(63.6 to 84.4)
7.Secondary Outcome
Title 2-year Overall Survival (OS) Rate (Phase III Secondary Endpoint)
Hide Description Overall survival is defined as the time from randomization to death or date last known alive among all randomized patients in the phase III part of the study. Kaplan-Meier method was used to estimate the 2-year OS rate.
Time Frame Assessed every 3 months for 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients in the phase III part of the study
Arm/Group Title Arm A (Lenalidomide; Phase III) Arm B (Observation; Phase III)
Hide Arm/Group Description:
Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo observation until progression to symptomatic myeloma.
Overall Number of Participants Analyzed 90 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.98
(0.95 to 1.00)
1.00
(1.00 to 1.00)
Time Frame Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
Adverse Event Reporting Description

Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events.

Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.

 
Arm/Group Title Arm A (Lenalidomide; Phase II) Arm A (Lenalidomide; Phase III) Arm B (Observation; Phase III)
Hide Arm/Group Description Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo observation until progression to symptomatic myeloma.
All-Cause Mortality
Arm A (Lenalidomide; Phase II) Arm A (Lenalidomide; Phase III) Arm B (Observation; Phase III)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/44 (15.91%)   2/90 (2.22%)   4/92 (4.35%) 
Hide Serious Adverse Events
Arm A (Lenalidomide; Phase II) Arm A (Lenalidomide; Phase III) Arm B (Observation; Phase III)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/44 (52.27%)   40/88 (45.45%)   8/86 (9.30%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  0/44 (0.00%)  2/88 (2.27%)  0/86 (0.00%) 
Blood and lymphatic disorders - Other  1  0/44 (0.00%)  1/88 (1.14%)  0/86 (0.00%) 
Cardiac disorders       
Myocardial infarction  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Ear and labyrinth disorders       
Hearing impaired  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Vertigo  1  0/44 (0.00%)  1/88 (1.14%)  0/86 (0.00%) 
Gastrointestinal disorders       
Constipation  1  0/44 (0.00%)  1/88 (1.14%)  0/86 (0.00%) 
Diarrhea  1  1/44 (2.27%)  3/88 (3.41%)  1/86 (1.16%) 
Vomiting  1  0/44 (0.00%)  1/88 (1.14%)  0/86 (0.00%) 
Gastrointestinal disorders - Other  1  0/44 (0.00%)  1/88 (1.14%)  0/86 (0.00%) 
General disorders       
Fatigue  1  5/44 (11.36%)  5/88 (5.68%)  0/86 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Immune system disorders       
Allergic reaction  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Infections and infestations       
Lung infection  1  1/44 (2.27%)  1/88 (1.14%)  0/86 (0.00%) 
Sepsis  1  2/44 (4.55%)  0/88 (0.00%)  0/86 (0.00%) 
Skin infection  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Investigations       
Creatinine increased  1  0/44 (0.00%)  0/88 (0.00%)  1/86 (1.16%) 
Lymphocyte count decreased  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Neutrophil count decreased  1  7/44 (15.91%)  12/88 (13.64%)  1/86 (1.16%) 
Platelet count decreased  1  0/44 (0.00%)  1/88 (1.14%)  0/86 (0.00%) 
Weight loss  1  1/44 (2.27%)  1/88 (1.14%)  0/86 (0.00%) 
White blood cell decreased  1  1/44 (2.27%)  1/88 (1.14%)  0/86 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  1/44 (2.27%)  1/88 (1.14%)  0/86 (0.00%) 
Hypokalemia  1  2/44 (4.55%)  0/88 (0.00%)  0/86 (0.00%) 
Hyponatremia  1  0/44 (0.00%)  0/88 (0.00%)  2/86 (2.33%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Myalgia  1  0/44 (0.00%)  2/88 (2.27%)  0/86 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Treatment related secondary malignancy  1  0/44 (0.00%)  2/88 (2.27%)  0/86 (0.00%) 
Nervous system disorders       
Ataxia  1  0/44 (0.00%)  1/88 (1.14%)  0/86 (0.00%) 
Dizziness  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Headache  1  2/44 (4.55%)  0/88 (0.00%)  0/86 (0.00%) 
Paresthesia  1  0/44 (0.00%)  0/88 (0.00%)  1/86 (1.16%) 
Peripheral motor neuropathy  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Peripheral sensory neuropathy  1  1/44 (2.27%)  2/88 (2.27%)  0/86 (0.00%) 
Syncope  1  0/44 (0.00%)  1/88 (1.14%)  0/86 (0.00%) 
Nervous system disorders - Other  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Psychiatric disorders       
Confusion  1  0/44 (0.00%)  1/88 (1.14%)  0/86 (0.00%) 
Insomnia  1  0/44 (0.00%)  1/88 (1.14%)  0/86 (0.00%) 
Renal and urinary disorders       
Acute kidney injury  1  0/44 (0.00%)  0/88 (0.00%)  1/86 (1.16%) 
Chronic kidney disease  1  0/44 (0.00%)  0/88 (0.00%)  1/86 (1.16%) 
Renal and urinary disorders - Other  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  0/44 (0.00%)  3/88 (3.41%)  0/86 (0.00%) 
Skin and subcutaneous tissue disorders       
Erythroderma  1  0/44 (0.00%)  1/88 (1.14%)  0/86 (0.00%) 
Pruritus  1  1/44 (2.27%)  0/88 (0.00%)  0/86 (0.00%) 
Rash maculo-papular  1  2/44 (4.55%)  2/88 (2.27%)  0/86 (0.00%) 
Vascular disorders       
Hypertension  1  0/44 (0.00%)  1/88 (1.14%)  2/86 (2.33%) 
Thromboembolic event  1  2/44 (4.55%)  1/88 (1.14%)  0/86 (0.00%) 
1
Term from vocabulary, CTCAE 4.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A (Lenalidomide; Phase II) Arm A (Lenalidomide; Phase III) Arm B (Observation; Phase III)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/44 (31.82%)   20/88 (22.73%)   5/86 (5.81%) 
Blood and lymphatic system disorders       
Anemia  1  6/44 (13.64%)  5/88 (5.68%)  2/86 (2.33%) 
Gastrointestinal disorders       
Constipation  1  2/44 (4.55%)  7/88 (7.95%)  1/86 (1.16%) 
General disorders       
Fatigue  1  4/44 (9.09%)  9/88 (10.23%)  2/86 (2.33%) 
Investigations       
Lymphocyte count decreased  1  3/44 (6.82%)  4/88 (4.55%)  2/86 (2.33%) 
Neutrophil count decreased  1  5/44 (11.36%)  8/88 (9.09%)  1/86 (1.16%) 
Platelet count decreased  1  5/44 (11.36%)  5/88 (5.68%)  1/86 (1.16%) 
White blood cell decreased  1  6/44 (13.64%)  9/88 (10.23%)  2/86 (2.33%) 
Skin and subcutaneous tissue disorders       
Rash maculo-papular  1  4/44 (9.09%)  1/88 (1.14%)  1/86 (1.16%) 
1
Term from vocabulary, CTCAE 4.0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: ECOG-ACRIN Biostatistics Center
Phone: 617-632-3012
EMail: eatrials@jimmy.harvard.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01169337    
Other Study ID Numbers: NCI-2011-02057
NCI-2011-02057 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E3A06 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E3A06 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
U24CA196172 ( U.S. NIH Grant/Contract )
First Submitted: July 23, 2010
First Posted: July 26, 2010
Results First Submitted: March 12, 2021
Results First Posted: May 18, 2021
Last Update Posted: May 18, 2021