Trial Outcomes & Findings for Lenalidomide/Bortezomib/Dexamethasone & CNTO 328 in Transplant Eligible Newly Diagnosed Multiple Myeloma (MM) (NCT NCT01531998)

NCT ID: NCT01531998

Last Updated: 2015-06-19

Results Overview

Maximum tolerated dose (MTD) defined as follows: At first dose level, if greater than 1 out of 3 patients or greater than 1 out of 6 patients experience dose limiting toxicity (DLT), the dose level exceeds the maximum tolerated dose (MTD). Dose limiting toxicity (DLT) defined as toxicities graded in severity according to the guidelines outlined in the NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

14 participants

Primary outcome timeframe

21 days

Results posted on

2015-06-19

Participant Flow

Recruitment Period: May 10, 2012 to February 08, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.

Of the fourteen participant enrolled, three were screen failures and not enrolled on the study.

Participant milestones

Participant milestones
Measure	Siltuximab + Bortezomib + Lenalidomide Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m\^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Siltuximab + Bortezomib + Lenalidomide Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m\^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Lenalidomide/Bortezomib/Dexamethasone & CNTO 328 in Transplant Eligible Newly Diagnosed Multiple Myeloma (MM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Siltuximab + Bortezomib + Lenalidomide n=11 Participants Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m\^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Outcome measures

Outcome measures
Measure	Siltuximab + Bortezomib + Lenalidomide n=6 Participants Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m\^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
Maximum Tolerated Dose (MTD) of Siltuximab	8.3 mg/kg

SECONDARY outcome

Timeframe: Evaluated after eight cycles of 21 days.

Overall response defined as number of participants with International Myeloma Working Group Uniform Response Criteria: Complete Response (CR): Negative immunofixation serum \& urine, Disappearance soft tissue plasmacytomas \& =/\<5% plasma cells in bone marrow; Stringent Complete Remission: CR + Normal Normal free light chain (FLC) ratio \& Absence clonal cells in bone marrow by Immunohistochemistry/ immunofluorescence; Very Good Partial Response (VGPR): Serum \& urine M-protein detectable by immunofixation but not on electrophoresis or 90%\> reduction in serum M-protein +urine M-protein level \<100mg per 24 hour; Partial Remission (PR): =/\>50% reduction serum M-protein \& reduction in 24-hour urinaryMprotein by \>90% or to \< 200mg per 24 hour, =/\>50% reduction of serum M-protein \& reduction in 24-hour urinary Mprotein by \>90%/or \<200mg, and if present at baseline, a \>50% reduction in size of soft tissue plasmacytomas; Stable Disease: Not CR, VGPR, PR Or Progressive disease

Outcome measures

Outcome measures
Measure	Siltuximab + Bortezomib + Lenalidomide n=11 Participants Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m\^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
Number of Participants With Response Very good partial remission (VGPR)	2 participants
Number of Participants With Response Partial Remission (PR)	6 participants
Number of Participants With Response Stable Disease	0 participants
Number of Participants With Response Complete Remission (CR)	2 participants
Number of Participants With Response Stringent Complete Remission	0 participants

Adverse Events

Siltuximab + Bortezomib + Lenalidomide

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Siltuximab + Bortezomib + Lenalidomide n=11 participants at risk Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m\^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
Renal and urinary disorders Hematuria	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Infections and infestations Lung infection	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.

Other adverse events

Other adverse events
Measure	Siltuximab + Bortezomib + Lenalidomide n=11 participants at risk Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m\^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
Blood and lymphatic system disorders Anemia	100.0% 11/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Blood and lymphatic system disorders Neutropenia	100.0% 11/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Blood and lymphatic system disorders Thrombocytopenia	100.0% 11/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Blood and lymphatic system disorders Lymphopenia	90.9% 10/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Blood and lymphatic system disorders Leukopenia	100.0% 11/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Blood and lymphatic system disorders Leukocytosis	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Alanine Aminotransferase Increased (ALT)	54.5% 6/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Alanine Aminotransferase Decreased (ALT)	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Aspartate Aminotransferase Increased (AST)	36.4% 4/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Alkaline Phosphatase Increased	36.4% 4/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Alkaline Phosphatase, Decreased	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Blood Bilirubin Increased	45.5% 5/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Blood urea nitrogen (BUN), Decreased	36.4% 4/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders BUN, Increased	45.5% 5/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Chloride, Decreased	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Chloride, Increased	45.5% 5/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Creatinine, Increased	54.5% 6/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Creatinine, Decreased	45.5% 5/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hyperalbuminemia	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hyperglycemia	63.6% 7/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hyperkalemia	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hypermagnesemia	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hypernatremia	27.3% 3/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hyperpophosphatemia	54.5% 6/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hyperuricemia	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hypoalbuminemia	63.6% 7/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hypoglycemia	45.5% 5/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hypophosphatamia	36.4% 4/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hypouricemia	45.5% 5/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hypocalcemia	72.7% 8/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hypokalemia	54.5% 6/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hypomagnesemia	63.6% 7/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Hyponatremia	36.4% 4/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Lactate dehydrogenase (LDH), Decreased	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders LDH, Increased	63.6% 7/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Protein, Decreased	54.5% 6/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders Protein, Increased	45.5% 5/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Metabolism and nutrition disorders TSH, Increased	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Gastrointestinal disorders Anorexia	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Immune system disorders Allergic Reaction	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Nervous system disorders Anxiety	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Musculoskeletal and connective tissue disorders Bone Pain	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Musculoskeletal and connective tissue disorders Back Pain	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Eye disorders Blurred Vision	63.6% 7/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
General disorders Chest Pain	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Gastrointestinal disorders Constipation	90.9% 10/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Respiratory, thoracic and mediastinal disorders Cough	27.3% 3/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Musculoskeletal and connective tissue disorders Cramps (Calf)	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Gastrointestinal disorders Dehydration	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Gastrointestinal disorders Diarrhea	54.5% 6/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Gastrointestinal disorders Dysgeusia	27.3% 3/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Nervous system disorders Dizziness	72.7% 8/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Eye disorders Dry Eye	72.7% 8/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Skin and subcutaneous tissue disorders Dry Skin	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Respiratory, thoracic and mediastinal disorders Dyspnea	54.5% 6/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Gastrointestinal disorders Dyspepsia	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
General disorders Edema: Limbs	90.9% 10/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
General disorders Edema: Trunk	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Eye disorders Eye Redness	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Eye disorders Eye Irritation	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
General disorders Fatigue	100.0% 11/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Musculoskeletal and connective tissue disorders Facial Drooping (left)	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Investigations Fever	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Gastrointestinal disorders Flatulence	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Musculoskeletal and connective tissue disorders Fracture	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Gastrointestinal disorders Gastritis	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Nervous system disorders Headache	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Respiratory, thoracic and mediastinal disorders Hiccups	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Endocrine disorders Hot Flashes	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Infections and infestations Infections and Infestations: Head Boils	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
General disorders Insomnia	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Nervous system disorders Memory Impairment	36.4% 4/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Nervous system disorders Mood Changes	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Gastrointestinal disorders Mucositis Oral	36.4% 4/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Musculoskeletal and connective tissue disorders Myalgia	72.7% 8/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Musculoskeletal and connective tissue disorders Muscular & connective tissue Disorder- Other: Muscle Pain	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Gastrointestinal disorders Nausea	72.7% 8/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
General disorders Pain (Generalized)	27.3% 3/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
General disorders Pain in Extremity	36.4% 4/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Cardiac disorders Palpitations	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Nervous system disorders Paresthesia	72.7% 8/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Nervous system disorders Peripheral Sensory Neuropathy	27.3% 3/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Infections and infestations Pneumonia	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Immune system disorders Post Nasal Drip	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Nervous system disorders Progressive Neuropathy	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Skin and subcutaneous tissue disorders Rash (Maculo- Papular)	36.4% 4/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
General disorders Soreness (Bilateral)	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Cardiac disorders Sinus Tachycardia	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Infections and infestations Upper Respiratory Infection	27.3% 3/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Renal and urinary disorders Urinary Incontinence	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Reproductive system and breast disorders Testicular pain	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Vascular disorders Thromboembolic event	9.1% 1/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Ear and labyrinth disorders Tinnitus	18.2% 2/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Gastrointestinal disorders Vomiting	27.3% 3/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.
Eye disorders Watering Eyes	54.5% 6/11 • Adverse event collection during the first cycle of 28-day study drug administration. Overall collection period: May 2012 to February 2013.

Additional Information

Jatin J. Shah, MD/Associate Professor, Lymphoma/Myeloma

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place