Trial Outcomes & Findings for Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib (NCT NCT01783522)
NCT ID: NCT01783522
Last Updated: 2019-10-22
Results Overview
The Neuropathy Impairment Score -Lower Limbs (NIS-LL) is the objective measurement of PNP symptoms. The degree of PNP will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03. The CTCAE is a 0-5 scale that assesses severity of neuropathy related to cancer therapy with higher scores meaning more symptoms A difference of 2 points between groups is considered significant. This measure will be performed at baseline and at 4 months.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
up to 4 months from start of study
Results posted on
2019-10-22
Participant Flow
Participant milestones
| Measure |
Arm I (Preventative Nutritional Supplementation)
Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
quality-of-life assessment: Ancillary studies
|
Arm II (Placebo)
Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
quality-of-life assessment: Ancillary studies
placebo: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib
Baseline characteristics by cohort
| Measure |
Arm I (Preventative Nutritional Supplementation)
n=4 Participants
Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
quality-of-life assessment: Ancillary studies
|
Arm II (Placebo)
n=5 Participants
Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
quality-of-life assessment: Ancillary studies
placebo: Given PO
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
n=85 Participants
|
64 years
n=18 Participants
|
55 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=85 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=85 Participants
|
3 Participants
n=18 Participants
|
6 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=85 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=85 Participants
|
5 Participants
n=18 Participants
|
9 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=85 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=85 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=85 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=85 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=85 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=85 Participants
|
5 Participants
n=18 Participants
|
8 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=85 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=85 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=85 Participants
|
5 participants
n=18 Participants
|
9 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: up to 4 months from start of studyPopulation: All participants enrolled in study and given treatment.
The Neuropathy Impairment Score -Lower Limbs (NIS-LL) is the objective measurement of PNP symptoms. The degree of PNP will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03. The CTCAE is a 0-5 scale that assesses severity of neuropathy related to cancer therapy with higher scores meaning more symptoms A difference of 2 points between groups is considered significant. This measure will be performed at baseline and at 4 months.
Outcome measures
| Measure |
Arm I (Preventative Nutritional Supplementation)
n=4 Participants
Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
quality-of-life assessment: Ancillary studies
|
Arm II (Placebo)
n=5 Participants
Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
quality-of-life assessment: Ancillary studies
placebo: Given PO
|
|---|---|---|
|
Degree of Peripheral Neuropathy (PNP)
|
3.40 units on a scale
Standard Deviation 7.83
|
3.40 units on a scale
Standard Deviation 7.83
|
SECONDARY outcome
Timeframe: Up to 4 monthsPopulation: All patients enrolled in study and given treatment
Adherence reported as a percentage based on number of doses of study drug taken divided by the expected number of doses of study drug expected to be taken for the study duration.
Outcome measures
| Measure |
Arm I (Preventative Nutritional Supplementation)
n=4 Participants
Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
quality-of-life assessment: Ancillary studies
|
Arm II (Placebo)
n=5 Participants
Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
quality-of-life assessment: Ancillary studies
placebo: Given PO
|
|---|---|---|
|
Adherence to Bortezomib Treatment
|
100 % of doses taken
|
98.2 % of doses taken
|
SECONDARY outcome
Timeframe: up to 4 months from start of studyPopulation: Subject data not collected due to low accrual. Research cancelled
RR (sCR+CR+VGPR+PR) according to uniform international response criteria and CBR (RR+MR according to modified EBMT criteria) will be assessed with SPEP, 24h UPEP, serum urine immunofixation, and serum free light chain assay at the start of each cycle and after completion of the 4th cycle.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to end of study at 4 monthsPopulation: All participants enrolled in study and given treatment.
Quality of life will be measured on the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) including 26 summed items (responses 0 to 4 to equal a possible total score 0-108). Higher scores represent better quality of life. Average change in Quality of Life scores from baseline to end of study will be reported for each separate arm
Outcome measures
| Measure |
Arm I (Preventative Nutritional Supplementation)
n=4 Participants
Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
quality-of-life assessment: Ancillary studies
|
Arm II (Placebo)
n=5 Participants
Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
quality-of-life assessment: Ancillary studies
placebo: Given PO
|
|---|---|---|
|
Average Change in Quality of Life Scores From Baseline to End of Study
|
-7.5 score on a scale
Standard Deviation 4.4
|
3.4 score on a scale
Standard Deviation 11.0
|
Adverse Events
Arm I (Preventative Nutritional Supplementation)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Preventative Nutritional Supplementation)
n=4 participants at risk
Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
quality-of-life assessment: Ancillary studies
|
Arm II (Placebo)
n=5 participants at risk
Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
quality-of-life assessment: Ancillary studies
placebo: Given PO
|
|---|---|---|
|
General disorders
Chills
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
Other adverse events
| Measure |
Arm I (Preventative Nutritional Supplementation)
n=4 participants at risk
Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
quality-of-life assessment: Ancillary studies
|
Arm II (Placebo)
n=5 participants at risk
Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
quality-of-life assessment: Ancillary studies
placebo: Given PO
|
|---|---|---|
|
Eye disorders
Blurred Vision
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 2 • Adverse event data was collected for 21 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
40.0%
2/5 • Number of events 5 • Adverse event data was collected for 21 months
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 2 • Adverse event data was collected for 21 months
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 4 • Adverse event data was collected for 21 months
|
|
General disorders
Fever
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 4 • Adverse event data was collected for 21 months
|
|
General disorders
Irritability
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
0.00%
0/5 • Adverse event data was collected for 21 months
|
|
General disorders
Pain
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
40.0%
2/5 • Number of events 4 • Adverse event data was collected for 21 months
|
|
Infections and infestations
Papulopustular rash
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
0.00%
0/5 • Adverse event data was collected for 21 months
|
|
Infections and infestations
Pharyngitis
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
0.00%
0/5 • Adverse event data was collected for 21 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected for 21 months
|
|
Investigations
Weight loss
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 3 • Adverse event data was collected for 21 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
0.00%
0/5 • Adverse event data was collected for 21 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
60.0%
3/5 • Number of events 4 • Adverse event data was collected for 21 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Cramps
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
0.00%
0/5 • Adverse event data was collected for 21 months
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
0.00%
0/5 • Adverse event data was collected for 21 months
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Nervous system disorders
Paresthesia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
0.00%
0/5 • Adverse event data was collected for 21 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 2 • Adverse event data was collected for 21 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for 21 months
|
0.00%
0/5 • Adverse event data was collected for 21 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - eczema
|
0.00%
0/4 • Adverse event data was collected for 21 months
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected for 21 months
|
Additional Information
Dr. Beth Faiman
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: 216-444-3705
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place