Trial Outcomes & Findings for Prevention of Treatment Induced Neuropathy in Multiple Myeloma (NCT NCT01283997)
NCT ID: NCT01283997
Last Updated: 2024-06-13
Results Overview
Touch detection thresholds are determined using the up/down method with calibrated von Frey monofilaments, Starting with a 0.5mN force, the von Frey monofilament is applied for approximately 1 sec. If the subject fails to detect the stimulus, then the next higher force von Frey monofilament is applied. When the subject detects the presence of the stimulus, the next lower von Frey is administered. The up/down test sequence continues until the same force filament is detected for three additional applications. The force of that filament is then assigned as the touch threshold
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
baseline and week 10
Results posted on
2024-06-13
Participant Flow
79 Participants signed consent
Participant milestones
| Measure |
Placebo Group
Participants received a placebo of one dose on the first day of induction therapy for multiple myeloma, then doses every 12 hours for 10 weeks.
|
Minocycline Group
Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
Reasons for withdrawal
| Measure |
Placebo Group
Participants received a placebo of one dose on the first day of induction therapy for multiple myeloma, then doses every 12 hours for 10 weeks.
|
Minocycline Group
Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma
|
|---|---|---|
|
Overall Study
Physician Decision
|
8
|
10
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Physically unable to continue
|
0
|
1
|
|
Overall Study
Progressive disease
|
1
|
0
|
|
Overall Study
Other
|
4
|
4
|
Baseline Characteristics
Prevention of Treatment Induced Neuropathy in Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Placebo Group
n=39 Participants
Participants received one pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.
|
Minocycline Group
n=40 Participants
Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
40 participants
n=7 Participants
|
79 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and week 10Touch detection thresholds are determined using the up/down method with calibrated von Frey monofilaments, Starting with a 0.5mN force, the von Frey monofilament is applied for approximately 1 sec. If the subject fails to detect the stimulus, then the next higher force von Frey monofilament is applied. When the subject detects the presence of the stimulus, the next lower von Frey is administered. The up/down test sequence continues until the same force filament is detected for three additional applications. The force of that filament is then assigned as the touch threshold
Outcome measures
| Measure |
Placebo Group
n=17 Participants
Participants received one pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.
|
Minocycline Group
n=19 Participants
Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma
|
|---|---|---|
|
The Difference Between Touch Detection Thresholds From the Sensorimotor Evaluation at Baseline and After 10 Weeks of Induction Therapy.
Fingertips
|
0.00 mN
Standard Deviation 0.25
|
0.06 mN
Standard Deviation 0.28
|
|
The Difference Between Touch Detection Thresholds From the Sensorimotor Evaluation at Baseline and After 10 Weeks of Induction Therapy.
Thenar Eminence
|
0.08 mN
Standard Deviation 0.26
|
0.13 mN
Standard Deviation 0.27
|
|
The Difference Between Touch Detection Thresholds From the Sensorimotor Evaluation at Baseline and After 10 Weeks of Induction Therapy.
Volar Forearm
|
0.09 mN
Standard Deviation 0.36
|
-0.03 mN
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: baseline and week 10Population: Participants with quantitative sensory testing (QST) done a week prior to the start of their minocycline treatment and with corresponding QST at week 10
Participants reported the severity of two cognitive symptoms numbness on a 0-10 scale, with 0 being 'not present' and 10 being 'as bad as you can imagine': Higher mean scores indicate more severe symptoms.
Outcome measures
| Measure |
Placebo Group
n=21 Participants
Participants received one pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.
|
Minocycline Group
n=20 Participants
Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma
|
|---|---|---|
|
Change in the Mean Value of Patient-reported MD Anderson Symptom Inventory for Multiple Myeloma (MDASI-MM) Numbness Scores From Baseline to Week 10 Post Treatment.
|
1.38 score on a scale
Standard Deviation 2.36
|
0.65 score on a scale
Standard Deviation 1.79
|
Adverse Events
Placebo Group
Serious events: 15 serious events
Other events: 39 other events
Deaths: 0 deaths
Minocycline Group
Serious events: 12 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Group
n=39 participants at risk
Participants received one pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.
|
Minocycline Group
n=40 participants at risk
Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma
|
|---|---|---|
|
Investigations
Elevated SGPT
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Elevated serum myeloma protein
|
15.4%
6/39 • From the first dose through 330 days after the last dose of study medication
|
25.0%
10/40 • From the first dose through 330 days after the last dose of study medication
|
|
Renal and urinary disorders
Elevated urinary protein
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Renal and urinary disorders
Elevated serum and urine protein
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Renal and urinary disorders
Abnormal serum and urine
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Vascular disorders
Hypertension
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Psychiatric disorders
Depression
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Elevated LDH
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Elevated serum total protein
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Renal and urinary disorders
Elevated serum myeloma protein
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Infections and infestations
Fungal pharyngitis
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Phosphatase, elevated serum proteins
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Infections and infestations
Pneumonia
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Infections and infestations
Urinary Tract Infection
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Renal and urinary disorders
Elevated serum and urinary myeloma protein
|
12.8%
5/39 • From the first dose through 330 days after the last dose of study medication
|
17.5%
7/40 • From the first dose through 330 days after the last dose of study medication
|
Other adverse events
| Measure |
Placebo Group
n=39 participants at risk
Participants received one pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.
|
Minocycline Group
n=40 participants at risk
Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Infections and infestations
Pharyngitis
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Infections and infestations
Sinusitis
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Gastrointestinal disorders
Oral pain
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Vascular disorders
Superficial thrombophlebitis
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Ear and labyrinth disorders
Tinnitus
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Infections and infestations
Upper respiratory infection
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Blood and lymphatic system disorders
Anemia
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
General disorders
Edema Limbs
|
7.7%
3/39 • From the first dose through 330 days after the last dose of study medication
|
12.5%
5/40 • From the first dose through 330 days after the last dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
23.1%
9/39 • From the first dose through 330 days after the last dose of study medication
|
10.0%
4/40 • From the first dose through 330 days after the last dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Blood and lymphatic system disorders - Other, specify
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Psychiatric disorders
Depression
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Gastrointestinal disorders
Dysphagia
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Nervous system disorders
Dizziness
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Eye disorders
Dry eye
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
General disorders
Generalized edema
|
10.3%
4/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Creatinine increased
|
7.7%
3/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Alkaline phosphatase increased
|
25.6%
10/39 • From the first dose through 330 days after the last dose of study medication
|
20.0%
8/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
13/39 • From the first dose through 330 days after the last dose of study medication
|
22.5%
9/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
12.8%
5/39 • From the first dose through 330 days after the last dose of study medication
|
7.5%
3/40 • From the first dose through 330 days after the last dose of study medication
|
|
Injury, poisoning and procedural complications
Investigations - Other, specify
|
15.4%
6/39 • From the first dose through 330 days after the last dose of study medication
|
20.0%
8/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Blood bilirubin increased
|
7.7%
3/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.6%
10/39 • From the first dose through 330 days after the last dose of study medication
|
35.0%
14/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
General disorders
Fatigue
|
12.8%
5/39 • From the first dose through 330 days after the last dose of study medication
|
15.0%
6/40 • From the first dose through 330 days after the last dose of study medication
|
|
General disorders
Fever
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Nervous system disorders
Headache
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
3/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
: - Hypercalcemia
|
7.7%
3/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Cholesterol high
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
10.3%
4/39 • From the first dose through 330 days after the last dose of study medication
|
10.0%
4/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Vascular disorders
Hypertension
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.6%
10/39 • From the first dose through 330 days after the last dose of study medication
|
30.0%
12/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.8%
5/39 • From the first dose through 330 days after the last dose of study medication
|
10.0%
4/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.5%
8/39 • From the first dose through 330 days after the last dose of study medication
|
22.5%
9/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.8%
5/39 • From the first dose through 330 days after the last dose of study medication
|
15.0%
6/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.3%
4/39 • From the first dose through 330 days after the last dose of study medication
|
10.0%
4/40 • From the first dose through 330 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Vascular disorders
Hypotension
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.9%
7/39 • From the first dose through 330 days after the last dose of study medication
|
20.0%
8/40 • From the first dose through 330 days after the last dose of study medication
|
|
Nervous system disorders
Amnesia
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
12.8%
5/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
43.6%
17/39 • From the first dose through 330 days after the last dose of study medication
|
17.5%
7/40 • From the first dose through 330 days after the last dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
3/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Nervous system disorders
Paresthesia
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.5%
8/39 • From the first dose through 330 days after the last dose of study medication
|
10.0%
4/40 • From the first dose through 330 days after the last dose of study medication
|
|
Renal and urinary disorders
Proteinuria
|
5.1%
2/39 • From the first dose through 330 days after the last dose of study medication
|
5.0%
2/40 • From the first dose through 330 days after the last dose of study medication
|
|
Eye disorders
Eye Pain
|
0.00%
0/39 • From the first dose through 330 days after the last dose of study medication
|
2.5%
1/40 • From the first dose through 330 days after the last dose of study medication
|
|
General disorders
Pain
|
17.9%
7/39 • From the first dose through 330 days after the last dose of study medication
|
20.0%
8/40 • From the first dose through 330 days after the last dose of study medication
|
|
Investigations
Neutrophil count decreased
|
2.6%
1/39 • From the first dose through 330 days after the last dose of study medication
|
0.00%
0/40 • From the first dose through 330 days after the last dose of study medication
|
Additional Information
Dr. Sheeba Thomas,Professor, Lymphoma-Myeloma
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