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Trial record 95 of 495 for:    LENALIDOMIDE AND every 28 days

Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00540644
Recruitment Status : Completed
First Posted : October 8, 2007
Results First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Attaya Suvannasankha, Indiana University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: lenalidomide (Revlimid®)
Drug: Cyclophosphamide
Drug: Prednisone
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Original Study - Revlimid, Cyclophosphamide, Prednisone Extension - Revlimid, Cyclophosphamide, Prednisone
Hide Arm/Group Description Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Period Title: Overall Study
Started 48 22
Completed 39 13
Not Completed 9 9
Reason Not Completed
Adverse Event             3             1
Disease Progression             3             1
Physician Decision             0             5
Withdrawal by Subject             2             2
Noncomplilance             1             0
Arm/Group Title Original Study - Revlimid, Cyclophosphamide, Prednisone Extension - Revlimid, Cyclophosphamide, Prednisone Total
Hide Arm/Group Description Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. Total of all reporting groups
Overall Number of Baseline Participants 48 22 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 22 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  54.2%
17
  77.3%
43
  61.4%
>=65 years
22
  45.8%
5
  22.7%
27
  38.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 22 participants 70 participants
61.9  (10.5) 59.9  (8.0) 61.2  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 22 participants 70 participants
Female
18
  37.5%
8
  36.4%
26
  37.1%
Male
30
  62.5%
14
  63.6%
44
  62.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 22 participants 70 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
48
 100.0%
22
 100.0%
70
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 22 participants 70 participants
American Indian or Alaska Native
0
   0.0%
1
   4.5%
1
   1.4%
Asian
1
   2.1%
0
   0.0%
1
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   8.3%
0
   0.0%
4
   5.7%
White
43
  89.6%
21
  95.5%
64
  91.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
Hide Description Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.
Time Frame After 6 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study drug and having at least one post-baseline visit
Arm/Group Title Original Study - Revlimid, Cyclophosphamide, Prednisone Extension - Revlimid, Cyclophosphamide, Prednisone
Hide Arm/Group Description:
Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Overall Number of Participants Analyzed 45 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.7
(73.2 to 95.0)
71.4
(47.8 to 88.7)
2.Secondary Outcome
Title Treatment Related Adverse Events Grade 3 or Higher
Hide Description Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.
Time Frame Beginning of treatment up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled and received treatment.
Arm/Group Title Original Study - Revlimid, Cyclophosphamide, Prednisone Extension - Revlimid, Cyclophosphamide, Prednisone
Hide Arm/Group Description:
Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Overall Number of Participants Analyzed 48 22
Measure Type: Number
Unit of Measure: participants
21 11
3.Secondary Outcome
Title Quality of Life Using the FACT-G Data
Hide Description

Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.

Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome

Time Frame baseline and after last cycle (up to 6 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled and received treatment with a baseline and post-baseline measurement.
Arm/Group Title Original Study - Revlimid, Cyclophosphamide, Prednisone Extension - Revlimid, Cyclophosphamide, Prednisone
Hide Arm/Group Description:
Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Overall Number of Participants Analyzed 29 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical Well-Being Change from Baseline 1.57  (6.20) -2.81  (6.14)
Social/Family Well-Being Change from Baseline -0.03  (5.08) -0.23  (3.53)
Emotional Well-Beling Change from Baseline 2.52  (3.95) 0.60  (3.22)
Functional Well-Being Change from Baseline 3.38  (5.33) -1.17  (4.97)
FACT-G Change from Baseline 7.44  (13.07) -3.61  (10.92)
Time Frame up to 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Original Study - Revlimid, Cyclophosphamide, Prednisone Extension - Revlimid, Cyclophosphamide, Prednisone
Hide Arm/Group Description Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
All-Cause Mortality
Original Study - Revlimid, Cyclophosphamide, Prednisone Extension - Revlimid, Cyclophosphamide, Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Original Study - Revlimid, Cyclophosphamide, Prednisone Extension - Revlimid, Cyclophosphamide, Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   12/48 (25.00%)   5/22 (22.73%) 
Blood and lymphatic system disorders     
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE * 1  2/48 (4.17%)  1/22 (4.55%) 
Cardiac disorders     
CARDIAC GENERAL - OTHER * 1  1/48 (2.08%)  0/22 (0.00%) 
General disorders     
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) * 1  2/48 (4.17%)  0/22 (0.00%) 
Infections and infestations     
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E * 1  1/48 (2.08%)  1/22 (4.55%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA) * 1  1/48 (2.08%)  0/22 (0.00%) 
Investigations     
HEMOGLOBIN * 1  0/48 (0.00%)  1/22 (4.55%) 
NEUTROPHILS/GRANULOCYTES (ANC/AGC) * 1  1/48 (2.08%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders     
PAIN - BACK * 1  1/48 (2.08%)  2/22 (9.09%) 
PAIN - EXTREMITY-LIMB * 1  1/48 (2.08%)  0/22 (0.00%) 
Nervous system disorders     
SEIZURE * 1  1/48 (2.08%)  0/22 (0.00%) 
Psychiatric disorders     
CONFUSION * 1  1/48 (2.08%)  1/22 (4.55%) 
Renal and urinary disorders     
RENAL FAILURE * 1  2/48 (4.17%)  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders     
PULMONARY/UPPER RESPIRATORY - OTHER * 1  1/48 (2.08%)  0/22 (0.00%) 
Vascular disorders     
FLU-LIKE SYNDROME * 1  1/48 (2.08%)  0/22 (0.00%) 
HYPOTENSION * 1  0/48 (0.00%)  1/22 (4.55%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Original Study - Revlimid, Cyclophosphamide, Prednisone Extension - Revlimid, Cyclophosphamide, Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   48/48 (100.00%)   22/22 (100.00%) 
Cardiac disorders     
PALPITATIONS * 1  2/48 (4.17%)  1/22 (4.55%) 
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA * 1  0/48 (0.00%)  1/22 (4.55%) 
Ear and labyrinth disorders     
AUDITORY/EAR - OTHER * 1  0/48 (0.00%)  1/22 (4.55%) 
OTITIS, MIDDLE EAR (NON-INFECTIOUS) * 1  0/48 (0.00%)  1/22 (4.55%) 
Eye disorders     
OCULAR/VISUAL - OTHER * 1  0/48 (0.00%)  1/22 (4.55%) 
Gastrointestinal disorders     
CONSTIPATION * 1  15/48 (31.25%)  9/22 (40.91%) 
DIARRHEA * 1  13/48 (27.08%)  12/22 (54.55%) 
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA) * 1  1/48 (2.08%)  1/22 (4.55%) 
DYSPHAGIA (DIFFICULTY SWALLOWING) * 1  1/48 (2.08%)  1/22 (4.55%) 
GASTROINTESTINAL - OTHER * 1  1/48 (2.08%)  3/22 (13.64%) 
HEARTBURN/DYSPEPSIA * 1  9/48 (18.75%)  6/22 (27.27%) 
HEMORRHOIDS * 1  0/48 (0.00%)  2/22 (9.09%) 
NAUSEA * 1  14/48 (29.17%)  8/22 (36.36%) 
PAIN - ABDOMEN NOS * 1  5/48 (10.42%)  3/22 (13.64%) 
PAIN - PELVIS * 1  0/48 (0.00%)  2/22 (9.09%) 
VOMITING * 1  3/48 (6.25%)  2/22 (9.09%) 
General disorders     
EDEMA: LIMB * 1  14/48 (29.17%)  8/22 (36.36%) 
FATIGUE (ASTHENIA, LETHARGY, MALAISE) * 1  24/48 (50.00%)  14/22 (63.64%) 
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) * 1  5/48 (10.42%)  7/22 (31.82%) 
PAIN - CHEST/THORAX NOS * 1  4/48 (8.33%)  2/22 (9.09%) 
PAIN - FACE * 1  0/48 (0.00%)  1/22 (4.55%) 
PAIN - OTHER * 1  6/48 (12.50%)  5/22 (22.73%) 
RIGORS/CHILLS * 1  6/48 (12.50%)  4/22 (18.18%) 
Infections and infestations     
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E * 1  2/48 (4.17%)  3/22 (13.64%) 
INFECTION - OTHER * 1  1/48 (2.08%)  1/22 (4.55%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY) * 1  1/48 (2.08%)  1/22 (4.55%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - DENTAL-TOOTH * 1  1/48 (2.08%)  1/22 (4.55%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA) * 1  2/48 (4.17%)  1/22 (4.55%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS * 1  3/48 (6.25%)  2/22 (9.09%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS * 1  1/48 (2.08%)  1/22 (4.55%) 
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA) * 1  0/48 (0.00%)  1/22 (4.55%) 
Injury, poisoning and procedural complications     
BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA) * 1  0/48 (0.00%)  2/22 (9.09%) 
BURN * 1  0/48 (0.00%)  1/22 (4.55%) 
FRACTURE * 1  0/48 (0.00%)  1/22 (4.55%) 
Investigations     
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTEREMIA) * 1  0/48 (0.00%)  1/22 (4.55%) 
CREATININE * 1  0/48 (0.00%)  1/22 (4.55%) 
HEARING: PATIENTS WITH/WITHOUT BASELINE AUDIOGRAM AND ENROLLED IN A MONITORING PROGRAM * 1  0/48 (0.00%)  1/22 (4.55%) 
HEMOGLOBIN * 1  2/48 (4.17%)  1/22 (4.55%) 
METABOLIC/LABORATORY - OTHER * 1  1/48 (2.08%)  1/22 (4.55%) 
NEUTROPHILS/GRANULOCYTES (ANC/AGC) * 1  7/48 (14.58%)  6/22 (27.27%) 
PLATELETS * 1  3/48 (6.25%)  0/22 (0.00%) 
Metabolism and nutrition disorders     
ANOREXIA * 1  6/48 (12.50%)  6/22 (27.27%) 
DEHYDRATION * 1  2/48 (4.17%)  1/22 (4.55%) 
POTASSIUM, SERUM-LOW (HYPOKALEMIA) * 1  1/48 (2.08%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders     
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTRAOCULAR * 1  1/48 (2.08%)  1/22 (4.55%) 
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER * 1  5/48 (10.42%)  1/22 (4.55%) 
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-UPPER * 1  5/48 (10.42%)  1/22 (4.55%) 
MUSCULOSKELETAL/SOFT TISSUE - OTHER * 1  3/48 (6.25%)  3/22 (13.64%) 
OSTEONECROSIS (AVASCULAR NECROSIS) * 1  0/48 (0.00%)  1/22 (4.55%) 
PAIN - BACK * 1  19/48 (39.58%)  9/22 (40.91%) 
PAIN - BONE * 1  12/48 (25.00%)  7/22 (31.82%) 
PAIN - EXTREMITY-LIMB * 1  6/48 (12.50%)  5/22 (22.73%) 
PAIN - JOINT * 1  14/48 (29.17%)  5/22 (22.73%) 
PAIN - MUSCLE * 1  2/48 (4.17%)  3/22 (13.64%) 
PAIN - NECK * 1  2/48 (4.17%)  2/22 (9.09%) 
Nervous system disorders     
ATAXIA (INCOORDINATION) * 1  0/48 (0.00%)  1/22 (4.55%) 
DIZZINESS * 1  9/48 (18.75%)  4/22 (18.18%) 
NEUROPATHY: SENSORY * 1  13/48 (27.08%)  6/22 (27.27%) 
PAIN - HEAD/HEADACHE * 1  2/48 (4.17%)  2/22 (9.09%) 
PAIN - SINUS * 1  0/48 (0.00%)  1/22 (4.55%) 
SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS * 1  0/48 (0.00%)  1/22 (4.55%) 
SYNCOPE (FAINTING) * 1  3/48 (6.25%)  1/22 (4.55%) 
TASTE ALTERATION (DYSGEUSIA) * 1  2/48 (4.17%)  2/22 (9.09%) 
TREMOR * 1  7/48 (14.58%)  3/22 (13.64%) 
Psychiatric disorders     
INSOMNIA * 1  18/48 (37.50%)  7/22 (31.82%) 
MOOD ALTERATION - ANXIETY * 1  4/48 (8.33%)  2/22 (9.09%) 
MOOD ALTERATION - DEPRESSION * 1  2/48 (4.17%)  2/22 (9.09%) 
Renal and urinary disorders     
RENAL/GENITOURINARY - OTHER * 1  0/48 (0.00%)  2/22 (9.09%) 
URINARY FREQUENCY/URGENCY * 1  2/48 (4.17%)  1/22 (4.55%) 
Reproductive system and breast disorders     
VAGINAL DRYNESS * 1  0/48 (0.00%)  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders     
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP) * 1  2/48 (4.17%)  1/22 (4.55%) 
COUGH * 1  16/48 (33.33%)  5/22 (22.73%) 
DYSPNEA (SHORTNESS OF BREATH) * 1  10/48 (20.83%)  12/22 (54.55%) 
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE * 1  0/48 (0.00%)  1/22 (4.55%) 
NASAL CAVITY/PARANASAL SINUS REACTIONS * 1  3/48 (6.25%)  0/22 (0.00%) 
PAIN - THROAT/PHARYNX/LARYNX * 1  2/48 (4.17%)  1/22 (4.55%) 
PULMONARY/UPPER RESPIRATORY - OTHER * 1  3/48 (6.25%)  3/22 (13.64%) 
Skin and subcutaneous tissue disorders     
DERMATOLOGY/SKIN - OTHER * 1  2/48 (4.17%)  2/22 (9.09%) 
DRY SKIN * 1  2/48 (4.17%)  3/22 (13.64%) 
PRURITUS/ITCHING * 1  16/48 (33.33%)  2/22 (9.09%) 
RASH/DESQUAMATION * 1  16/48 (33.33%)  8/22 (36.36%) 
RASH: ACNE/ACNEIFORM * 1  4/48 (8.33%)  1/22 (4.55%) 
SWEATING (DIAPHORESIS) * 1  10/48 (20.83%)  6/22 (27.27%) 
Vascular disorders     
HYPERTENSION * 1  1/48 (2.08%)  1/22 (4.55%) 
THROMBOSIS/THROMBUS/EMBOLISM * 1  1/48 (2.08%)  1/22 (4.55%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Attaya Suvannasankha
Organization: IndianaU
Phone: 317-944-0920
EMail: asuvanna@iu.edu
Layout table for additonal information
Responsible Party: Attaya Suvannasankha, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00540644     History of Changes
Other Study ID Numbers: 0704-06; IUCRO-0170
First Submitted: October 5, 2007
First Posted: October 8, 2007
Results First Submitted: April 5, 2016
Results First Posted: June 21, 2016
Last Update Posted: June 21, 2016