Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01946152
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 21
• Location: 1
• Arm: 1
• Actual Duration (Months): 72.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This phase I/II trial studies the side effects and the best dose of pomalidomide when given together with dexamethasone and filgrastim-sndz and to see how well they work in treating patients with multiple myeloma that has returned or that does not respond to treatment. Pomalidomide may stimulate or suppress the immune system in different ways and may stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Colony-stimulating factors, such as filgrastim-sndz, may increase the production of red and white blood cells and may help the immune system recover from the side effects of pomalidomide and/or dexamethasone. Giving pomalidomide together with dexamethasone and filgrastim-sndz may work better in treating patients with multiple myeloma.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma-Light Chain Only; Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma	Drug: Dexamethasone; Biological: Filgrastim-sndz; Other: Laboratory Biomarker Analysis; Drug: Pomalidomide	Phase 1/Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To determine the maximum tolerated dose (MTD) of pomalidomide and dexamethasone when given with growth factor support in patients with relapsed and refractory multiple myeloma. (Phase

1. 1. To evaluate the safety of pomalidomide and dexamethasone at the MTD. (Phase II)

SECONDARY OBJECTIVES:

1. To obtain preliminary estimates of the anti-myeloma activity of higher doses of pomalidomide given with low dose dexamethasone and growth factor support in patients with relapsed and refractory multiple myeloma.

2. Activity will be defined by the overall response rate (ORR); (partial response [PR] or better) and clinical benefit response (CBR) rate (minor response [MR] or better), as well as by the response durability (duration of response [DOR], progression-free survival [PFS], and time to progression [TTP]).

3. To further evaluate the safety of pomalidomide and dexamethasone at the maximum tolerated dose (MTD).

EXPLORATORY OBJECTIVES:

1. To examine the influence of cereblon expression and activation of the wingless-type (Wnt)/beta-catenin pathway on the activity of high dose pomalidomide with low dose dexamethasone.

OUTLINE: This is a phase I, dose-escalation study of pomalidomide followed by a phase II study.

INDUCTION: Patients receive pomalidomide orally (PO) daily on days 1-21, dexamethasone PO on days 1, 8, 15, and 22, and filgrastim-sndz subcutaneously (SC) on days 22-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive lower-dose pomalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I/II Study of Pomalidomide and Dexamethasone With Growth Factor Support in Patients With Relapsed/Refractory Multiple Myeloma
• Actual Study Start Date: Mar 5, 2014
• Actual Primary Completion Date: Mar 18, 2020
• Actual Study Completion Date: Mar 18, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment (pomalidomide, dexamethasone, filgrastim-sndz) INDUCTION: Patients receive pomalidomide PO daily on days 1-21, dexamethasone PO on days 1, 8, 15, and 22, and filgrastim-sndz SC on days 22-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive lower-dose pomalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Dexamethasone; Given PO; Other Names: Aacidexam Adexone Aknichthol Dexa Alba-Dex Alin Alin Depot Alin Oftalmico Amplidermis Anemul mono Auricularum Auxiloson Baycuten Baycuten N Cortidexason Cortisumman Decacort Decadrol Decadron Decalix Decameth Decasone R.p. Dectancyl Dekacort Deltafluorene Deronil Desamethasone Desameton Dexa-Mamallet Dexa-Rhinosan Dexa-Scheroson Dexa-sine Dexacortal Dexacortin Dexafarma Dexafluorene Dexalocal Dexamecortin Dexameth Dexamethasonum Dexamonozon Dexapos Dexinoral Dexone Dinormon Fluorodelta Fortecortin Gammacorten Hexadecadrol Hexadrol Lokalison-F Loverine Methylfluorprednisolone Millicorten Mymethasone Orgadrone Spersadex Visumetazone ; Biological: Filgrastim-sndz; Given SC; Other Names: Filgrastim Biosimilar Filgrastim-sndz Zarxio ; Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Pomalidomide; Given PO; Other Names: 4-Aminothalidomide Actimid CC-4047 Imnovid Pomalyst

Outcome Measures

Primary Outcome Measures

1. Maximum Tolerated Dose (MTD) (Phase I) [28 days]

   Safety and tolerability will be assessed by clinical review of all relevant parameters, including dose limiting toxicities. Toxicity type and severity will be summarized by frequency tables. Maximum tolerated dose defined as the highest dose level in which patients have been treated with less than 2 instances of dose-limiting toxicity (Phase I)

2. Number of Participants Recommended Phase II Dose of Pomalidomide and Dexamethasone, When Both Agents Are Administered Together With Granulocyte-colony Stimulating Factor (Filgrastim) (Phase I) [Up to 28 days]

Secondary Outcome Measures

1. Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC) [After 112 days (4 courses) of therapy]

   Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC): Complete Response (CR), Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow; Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours; Partial Response (PR), > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h; Stable Disease (SD) = CR + PR.

2. Number of Participants With Progression-free Survival [Up to 6 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Relapsed and/or refractory multiple myeloma with measurable disease, as defined by one or both of the following (assessed within 14 days prior to initiation of therapy): a) serum myeloma protein (M-protein) >= 0.5 g/d; b) urine Bence-Jones protein >= 200 mg/24 hours

• Patients with light chain only myeloma are eligible; the involved free light chain level >= 100 mg/L with abnormal serum free light chain ratio

• Patients must have prior treatment with >= 2 cycles of lenalidomide and >= 2 cycles of bortezomib (either in separate regimens or as part of the same regimen) (primary refractory of subjects refractory to the most recent regimen are eligible)

• The patient has received =< 5 lines of prior therapy

• Eastern Cooperative Oncology Group performance status 0 - 2

• Serum alanine aminotransferase (ALT) < 3.5 times the upper limit of normal within 7 days of time of consent

• Serum direct bilirubin < 2 mg/dL (34 Omol/L) within 7 days of time of consent

• Absolute neutrophil count (ANC) >= 1.0 x 10^9/L within 7 days of time of consent, without granulocyte- colony stimulating factor (G-CSF)

• Hemoglobin > 9 g/dL (80 g/L) within 7 days of time of consent (subjects may be receiving red blood cell transfusions in accordance with institutional guidelines)

• Platelet count > 100 x 10^9/L

• Creatinine clearance > 50 mL/minute within 7 days of time of consent, either measured or calculated using a standard formula (e.g., Cockcroft and Gault)

• Written informed consent in accordance with federal, local, and institutional guidelines

• All study participants must be registered into the mandatory POMALYST (pomalidomide) Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the POMALYST REMS program

• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting cycle 1 of pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide; FCBP must also agree to ongoing pregnancy testing and follow pregnancy testing requirements as outlined in the POMALYST REMS program; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure

Exclusion Criteria:

• Hypersensitivity to previous lenalidomide or thalidomide

• History of serious allergic reactions to pegfilgrastim or filgrastim

• Chemotherapy (approved or investigational) within 3 weeks prior to signing consent

• Antibody therapy within 6 weeks prior to signing consent

• Radiotherapy to >= 3 sites at the same time within 1 week prior to signing consent

• Immunotherapy within 28 days prior to signing consent

• Pregnant or breast feeding females

• Major surgery within 21 days prior to signing consent

• Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to signing consent

• Known human immunodeficiency virus infection

• Known active hepatitis B or C infection

• Unstable angina or myocardial infarction within 4 months prior to registration, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or grade 3 conduction system abnormalities unless subject has a pacemaker

• Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to signing consent

• Non-hematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas

• Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to signing consent

• Subjects with known or likely systemic amyloidosis

• Ongoing graft-vs-host disease

• Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Luhua (Michael) Wang, M.D. Anderson Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 3, 2018

More Information

Additional Information:

• MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT01946152
• Other Study ID Numbers: 2013-0018; NCI-2014-01270; NCI-2014-00159; 2013-0018
• First Posted: Sep 19, 2013
• Last Update Posted: Jul 30, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Dexamethasone; Dexamethasone acetate; Pomalidomide; Ichthammol; Lenograstim; BB 1101

Study Results

Participant Flow

Pre-assignment Detail	21 participants enrolled, 20 evaluable and 1 screen failure.

Arm/Group Title	Cohort 0	Cohort I	Cohort II	Maximum Tolerated Dose (MTD)
Arm/Group Description	4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.	5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.	6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.	5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
Period Title: Overall Study
STARTED	3	3	6	8
COMPLETED	2	0	0	0
NOT COMPLETED	1	3	6	8

Baseline Characteristics

Arm/Group Title	Cohort 0	Cohort I	Cohort II	Maximum Tolerated Dose (MTD)	Total
Arm/Group Description	4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.	5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.	6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.	5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.	Total of all reporting groups
Overall Participants	3	3	6	8	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	1 33.3%	1 33.3%	2 33.3%	4 50%	8 40%
>=65 years	2 66.7%	2 66.7%	4 66.7%	4 50%	12 60%
Sex: Female, Male (Count of Participants)
Female	2 66.7%	3 100%	2 33.3%	3 37.5%	10 50%
Male	1 33.3%	0 0%	4 66.7%	5 62.5%	10 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	2 66.7%	1 16.7%	1 12.5%	4 20%
Not Hispanic or Latino	3 100%	0 0%	4 66.7%	7 87.5%	14 70%
Unknown or Not Reported	0 0%	1 33.3%	1 16.7%	0 0%	2 10%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	1 33.3%	0 0%	0 0%	1 12.5%	2 10%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	1 33.3%	0 0%	3 50%	1 12.5%	5 25%
White	1 33.3%	3 100%	2 33.3%	5 62.5%	11 55%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	1 16.7%	1 12.5%	2 10%
Region of Enrollment (participants) [Number]
United States	3 100%	3 100%	6 100%	8 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Maximum Tolerated Dose (MTD) (Phase I)
Description	Safety and tolerability will be assessed by clinical review of all relevant parameters, including dose limiting toxicities. Toxicity type and severity will be summarized by frequency tables. Maximum tolerated dose defined as the highest dose level in which patients have been treated with less than 2 instances of dose-limiting toxicity (Phase I)
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Maximum Tolerated Dose (MTD)
Arm/Group Description	5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
Measure Participants	8
Number [mg]	5

2. Primary Outcome

Title	Number of Participants Recommended Phase II Dose of Pomalidomide and Dexamethasone, When Both Agents Are Administered Together With Granulocyte-colony Stimulating Factor (Filgrastim) (Phase I)
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Data provided for the Participants who received MTD

Arm/Group Title	Maximum Tolerated Dose (MTD)
Arm/Group Description	5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
Measure Participants	8
Count of Participants [Participants]	8 266.7%

3. Secondary Outcome

Title	Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
Description	Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC): Complete Response (CR), Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow; Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours; Partial Response (PR), > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h; Stable Disease (SD) = CR + PR.
Time Frame	After 112 days (4 courses) of therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 0	Cohort I	Cohort II	Maximum Tolerated Dose (MTD)
Arm/Group Description	4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.	5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.	6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.	5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
Measure Participants	3	3	6	8
Partial Response	1 33.3%	2 66.7%	3 50%	6 75%
Progression Disease	0 0%	1 33.3%	1 16.7%	0 0%
Stable Disease	1 33.3%	0 0%	1 16.7%	1 12.5%
Complete Response	0 0%	0 0%	0 0%	0 0%
Very Good Partial Response (VGPR)	1 33.3%	0 0%	0 0%	1 12.5%
Non evaluable	0 0%	0 0%	1 16.7%	0 0%

4. Secondary Outcome

Title	Number of Participants With Progression-free Survival
Time Frame	Up to 6 years

Outcome Measure Data

Analysis Population Description

Data provided for the Participants who received MTD

Arm/Group Title	Maximum Tolerated Dosage (MTD)
Arm/Group Description	5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
Measure Participants	8
Count of Participants [Participants]	3 100%

Adverse Events

Time Frame	From start of treatment until 30 days after last dose, up to 6 years
Arm/Group Title	Cohort 0		Cohort 1		Cohort 2		Maximum Tolerated Dose (MTD)
Arm/Group Description	4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.		5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.		6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.		5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
All Cause Mortality
	Cohort 0		Cohort 1		Cohort 2		Maximum Tolerated Dose (MTD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)		0/6 (0%)		0/8 (0%)
Serious Adverse Events
	Cohort 0		Cohort 1		Cohort 2		Maximum Tolerated Dose (MTD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		1/3 (33.3%)		2/6 (33.3%)		1/8 (12.5%)
Cardiac disorders
Syncope	0/3 (0%)		0/3 (0%)		0/6 (0%)		1/8 (12.5%)
Dyspnea	0/3 (0%)		0/3 (0%)		0/6 (0%)		1/8 (12.5%)
Ear and labyrinth disorders
Sinusitis	0/3 (0%)		0/3 (0%)		2/6 (33.3%)		0/8 (0%)
Gastrointestinal disorders
Fecal Incontinence	0/3 (0%)		0/3 (0%)		1/6 (16.7%)		0/8 (0%)
General disorders
Squamous Cell CA	0/3 (0%)		0/3 (0%)		1/6 (16.7%)		0/8 (0%)
Infections and infestations
Febrile Neutropenia	0/3 (0%)		0/3 (0%)		1/6 (16.7%)		0/8 (0%)
Upper Respiratory Infection	0/3 (0%)		0/3 (0%)		1/6 (16.7%)		0/8 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/3 (0%)		0/3 (0%)		0/6 (0%)		1/8 (12.5%)
Respiratory, thoracic and mediastinal disorders
Lung Infection	0/3 (0%)		0/3 (0%)		0/6 (0%)		1/8 (12.5%)
Surgical and medical procedures
Fall/Hip Surgery	0/3 (0%)		1/3 (33.3%)		0/6 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 0		Cohort 1		Cohort 2		Maximum Tolerated Dose (MTD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)		1/3 (33.3%)		2/6 (33.3%)		4/8 (50%)
Cardiac disorders
Chest Pain	0/3 (0%)		0/3 (0%)		1/6 (16.7%)		1/8 (12.5%)
General disorders
Fatigue	1/3 (33.3%)		0/3 (0%)		1/6 (16.7%)		0/8 (0%)
Secondary Cancers	0/3 (0%)		0/3 (0%)		0/6 (0%)		2/8 (25%)
Myalgia	0/3 (0%)		1/3 (33.3%)		0/6 (0%)		0/8 (0%)
Immune system disorders
Anemia	0/3 (0%)		1/3 (33.3%)		0/6 (0%)		0/8 (0%)
Infections and infestations
Febrile Neutropenia	0/3 (0%)		0/3 (0%)		1/6 (16.7%)		0/8 (0%)
Infection	0/3 (0%)		0/3 (0%)		1/6 (16.7%)		4/8 (50%)
Upper Respiratory Tract Infection	0/3 (0%)		1/3 (33.3%)		2/6 (33.3%)		0/8 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/3 (0%)		0/3 (0%)		2/6 (33.3%)		0/8 (0%)
Pain Extremity	1/3 (33.3%)		0/3 (0%)		1/6 (16.7%)		0/8 (0%)
Nervous system disorders
Peripheral Sensory Neuropathy	1/3 (33.3%)		1/3 (33.3%)		0/6 (0%)		0/8 (0%)
Dizziness	0/3 (0%)		1/3 (33.3%)		0/6 (0%)		0/8 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	0/3 (0%)		1/3 (33.3%)		1/6 (16.7%)		0/8 (0%)
Lung Infection	0/3 (0%)		0/3 (0%)		0/6 (0%)		1/8 (12.5%)
Sinusitis	0/3 (0%)		0/3 (0%)		0/6 (0%)		1/8 (12.5%)
Skin and subcutaneous tissue disorders
Skin Disorders	1/3 (33.3%)		0/3 (0%)		0/6 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.