Chemotherapeutic Agent ToxicityPhase 2NCT01783522
Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib
A Phase 2 study testing glutamine and quality-of-life assessment in people with Chemotherapeutic Agent Toxicity and Multiple Myeloma, run by Beth Faiman at 1 site in United States.
Trial summary
This randomized phase II trial studies glutamine in preventing peripheral neuropathy in patients with multiple myeloma who are receiving bortezomib. Glutamine may help prevent peripheral neuropathy in patients receiving chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapeutic Agent Toxicity, Multiple Myeloma, Peripheral Neuropathy
- What is being tested?
- glutamine and quality-of-life assessment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of multiple myeloma who received bortezomib at a dose of 1.3mg/m2 SQ weekly
- No evidence of severe pre-existing peripheral neuropathy, NCI-CTCAE v4.03 =< 2
- Performance status =< 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Who cannot join
- Concurrent use of thalidomide, vincristine, platinum compound, or other agent known to cause significant neuropathy (concurrent lenalidomide will be allowed)
- Hospitalization with clinical evidence of active infections as manifested by recurrent fevers, positive blood culture results, or requiring intravenous antibiotic therapy
- Inadequate liver and renal function with liver transaminases 3x the upper limit of normal
- Glomerular filtration rate (GFR) according to Cockcroft-Gault < 30 mL/min
- Uncontrolled congestive heart failure
- Uncontrolled mood disorders
Show all 13Show fewer
- Fasting blood glucose >150mg/dL or blood sugar (non-fasting) >200mg/dL if no history of diabetes. Uncontrolled diabetes with HgA1C greater 7% with last evaluation.
- Seizure disorder
- Monosodium glutamate (MSG) allergy or soy allergy
- Life expectancy of shorter than 3 months based on clinical laboratory parameters and the investigator's opinion
- Uncorrected Vitamin B12 or folate deficiency on last evaluation.
- Use of over the counter (OTC) supplements other than one multivitamin tablet a day
- Women who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: A Placebo Controlled Study to Estimate the Effect Size of Glutamine as a Supplement to Prevent Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma Patients
This randomized phase II trial studies glutamine in preventing peripheral neuropathy in patients with multiple myeloma who are receiving bortezomib. Glutamine may help prevent peripheral neuropathy in patients receiving chemotherapy
Read the detailed description
PRIMARY OBJECTIVES:
- Estimate the objective effect size of glutamine compared to placebo as a prophylactic intervention to prevent bortezomib-induced peripheral neuropathy in multiple myeloma patients 4 months after their first dose of study drug.
SECONDARY OBJECTIVES:
- Estimate whether glutamine delays or prevents the onset or worsening of any neuropathy as determined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.
II. Determine if glutamine may improve adherence to bortezomib therapy.
III. Assess response rate (RR) and clinical benefit response rate (CBR) according to uniform international response criteria and modified European Group for Blood and Marrow Transplantation (EBMT) criteria.
IV. Determine if glutamine may improve quality of life (QOL) at 4 months.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive glutamine orally (PO) twice daily (BID). Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
- Being tested
- glutamine, quality-of-life assessment, placebo
- Medical subject headings
- Multiple Myeloma, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutamineDrug
Also called 2-aminoglutaramic acid, Gln, glutamic acid 5-amide, L-glutamine
Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
placeboOther
Also called PLCB
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (preventative nutritional supplementation) | Experimental | Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: glutamine; Other: quality-of-life assessment |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. Receives: Other: quality-of-life assessment; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Peripheral Neuropathy (PNP)
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.
Measured: up to 4 months from start of study
Secondary outcomes (3)
Adherence to Bortezomib 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.
Measured: Up to 4 months
RR (Complete Remission [sCR+CR+Very Good Partial Remission [VGPR]+Partial Remission [PR])
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.
Measured: up to 4 months from start of study
Average Change in Quality of Life Scores From Baseline to End of Study
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
Measured: from baseline to end of study at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Research Cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chemotherapeutic Agent ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Faiman
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Beth Faiman, Case Comprehensive Cancer Center
- Investigators
- Beth Faiman, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783522
- Sponsor's protocol ID
- CASE2A10
- Other IDs
- NCI-2011-01866
- Status last verified
- Jul 2019
- First submitted
- 31 Jan 2013
- Last updated
- 22 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled Study to Estimate the Effect Size of Glutamine as a Supplement to Prevent Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT01783522
- Acronym / sponsor ID
- CASE2A10
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research Cancelled
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Beth FaimanUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Posted 22 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies glutamine in preventing peripheral neuropathy in patients with multiple myeloma who are receiving bortezomib. Glutamine may help prevent peripheral neuropathy in patients receiving chemotherapy
Detailed description
PRIMARY OBJECTIVES:
- Estimate the objective effect size of glutamine compared to placebo as a prophylactic intervention to prevent bortezomib-induced peripheral neuropathy in multiple myeloma patients 4 months after their first dose of study drug.
SECONDARY OBJECTIVES:
- Estimate whether glutamine delays or prevents the onset or worsening of any neuropathy as determined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.
II. Determine if glutamine may improve adherence to bortezomib therapy.
III. Assess response rate (RR) and clinical benefit response rate (CBR) according to uniform international response criteria and modified European Group for Blood and Marrow Transplantation (EBMT) criteria.
IV. Determine if glutamine may improve quality of life (QOL) at 4 months.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive glutamine orally (PO) twice daily (BID). Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (preventative nutritional supplementation) | Experimental | Drug: glutamine, Other: quality-of-life assessmentPatients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. |
| Arm II (placebo) | Placebo comparator | Other: quality-of-life assessment, Other: placeboPatients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of multiple myeloma who received bortezomib at a dose of 1.3mg/m2 SQ weekly
- No evidence of severe pre-existing peripheral neuropathy, NCI-CTCAE v4.03 =< 2
- Performance status =< 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Key exclusion criteria (13 listed)
- Concurrent use of thalidomide, vincristine, platinum compound, or other agent known to cause significant neuropathy (concurrent lenalidomide will be allowed)
- Hospitalization with clinical evidence of active infections as manifested by recurrent fevers, positive blood culture results, or requiring intravenous antibiotic therapy
- Inadequate liver and renal function with liver transaminases 3x the upper limit of normal
- Glomerular filtration rate (GFR) according to Cockcroft-Gault < 30 mL/min
- Uncontrolled congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glutamineAlso: 2-aminoglutaramic acid, Gln, glutamic acid 5-amide, L-glutamineDose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months. | Drug | Arm I (preventative nutritional supplementation) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Arm I (preventative nutritional supplementation), Arm II (placebo) |
| placeboAlso: PLCBGiven PO | Other | Arm II (placebo) |
Primary outcome
Degree of Peripheral Neuropathy (PNP)
Time frame: up to 4 months from start of study
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.
3 secondary outcomes
Adherence to Bortezomib Treatment
Time frame: Up to 4 months
RR (Complete Remission [sCR+CR+Very Good Partial Remission [VGPR]+Partial Remission [PR])
Time frame: up to 4 months from start of study
Average Change in Quality of Life Scores From Baseline to End of Study
Time frame: from baseline to end of study at 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Faiman principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glutamine and quality-of-life assessment in people with Chemotherapeutic Agent Toxicity and Multiple Myeloma, run by Beth Faiman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Peripheral Neuropathy (PNP) (time frame: up to 4 months from start of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.