Monoclonal Gammopathy of Undetermined SignificancePhase 2NCT00899353

Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)

A Phase 2 study testing Omega 3 Fatty Acid in people with Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma, run by Marshall University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Chronic Lymphocytic Leukemia
What is being tested?: Omega 3 Fatty Acid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Aug 2008to Oct 2012
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

Must be over 18 years of age.
Must be free of other medical conditions that would decrease life expectancy to less that 12 months.
Must be free of Omega 3 supplements or other fish oil containing nutritional supplements for a minimum of two months prior to enrollment.
Must have a ECOG performance status of 0,1 or 2.

Who cannot join

Any life-threatening condition such as (but not limited to) advanced heart disease, kidney or liver failure with an expected survival of less than 12 months.
Any other active malignancy.
Women who are pregnant or lactating.
Individuals unable to give informed consent.
Individuals with known allergy or intolerance to fish oil supplements.
Any patient with an active bleeding diatheses or disorder.
ECOG performance status of 3 or 4.

Trial locations and contacts

1 site in 1 country.

United States1 site

Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701

Other trials in United States

About this study

Official title: Inhibition of Nuclear Factor Kappa B for Prevention of Disease Progression in Indolent B Cell Malignancies

Escalating doses of Omega 3 Fatty Acids are being used in patients who have early stage Chronic Lymphocytic Leukemia (ES-CLL), Monoclonal Gammopathy of Undetermined Significance (MGUS), or Smoldering Multiple Myeloma (SMM), whose disease does not currently require treatment. The primary aim of the study is to determine if the Omega 3 supplementation will help prevent or delay progression of the disease to a stage that requires treatment.

Conditions: Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Chronic Lymphocytic Leukemia
Being tested: Omega 3 Fatty Acid
Keywords: ES-CLL, MGUS, SMM, Early Stage - Chronic Lymphocytic Leukemia
Medical subject headings: Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omega 3 Fatty AcidDietary supplement
Also called Res-Q® 1250
Omega 3 supplementation will be initiated at three 1250 mg capsules daily for the first month. If dose is well tolerated, it will be increased to six 1250 mg capsules daily for 30 days, and finally to nine 1250 mg capsules daily. Treatment period is 12 months.

Study groups in NCT00899353
Study group	Role	What they receive
Omega 3 supplement	Experimental	Omega 3 supplement will be added to diet, 3 capsules per day for one month then 6 capsules per day for one month then 9 capsules per day as tolerated Receives: Dietary Supplement: Omega 3 Fatty Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.
Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer's protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.
Measured: baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)
The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.
Patients diagnosed with early stage (asymptomatic) CLL were supplemented with escalating doses of omega-3 (n-3) fatty acids (2.4 g of n-3/day up to 7.2 g of n-3/day). Given that these patients are asymptomatic and did not require treatment, measures of tumor mass during and after omega-3 supplementation, as evaluated by standard clinical tests of disease activity, were not performed. Instead, absolute lymphocyte counts (ALC), as a measure of tumor burden, was evaluated before and after omega-3 supplementation. Data represents the fold change in ALC post omega-3 consumption as compared to baseline ALC.
Patients with MGUS or SMM were not enrolled into this study.
Measured: Baseline, month 1, month 2, month 3, month 6, month 9, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Oct 2012

First posted12 May 2009 (estimated)
Study startAug 2008
Primary completionDec 2011
Study completionOct 2012

Why it stopped: Original Principal Investigator left the institution.

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Monoclonal Gammopathy of Undetermined SignificanceStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00899353
Sponsor's protocol ID: MU9230
Status last verified: Nov 2013
First submitted: 8 May 2009
Last updated: 12 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Witte TR, Salazar AJ, Ballester OF, Hardman WE. RBC and WBC fatty acid composition following consumption of an omega 3 supplement: lessons for future clinical trials. Lipids Health Dis. 2010 Mar 22;9:31. doi: 10.1186/1476-511X-9-31.
PubMed 20307284

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Monoclonal Gammopathy of Undetermined Significance trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inhibition of Nuclear Factor Kappa B for Prevention of Disease Progression in Indolent B Cell Malignancies
ClinicalTrials.gov ID: NCT00899353
Acronym / sponsor ID: MU9230
Conditions: Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Chronic Lymphocytic Leukemia
Keywords: ES-CLL, MGUS, SMM, Early Stage - Chronic Lymphocytic Leukemia
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Original Principal Investigator left the institution.
Enrolment: 16 participants (actual)
Lead sponsor: Marshall UniversityUniversity, hospital or other
Collaborators: Edwards Foundation, Inc.
Study start: Aug 2008
Primary completion: Dec 2011 (actual)
Study completion: Oct 2012 (actual)
First posted: 12 May 2009 (estimated)
Results: Posted 18 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Omega 3 supplement	Experimental	Dietary Supplement: Omega 3 Fatty AcidOmega 3 supplement will be added to diet, 3 capsules per day for one month then 6 capsules per day for one month then 9 capsules per day as tolerated

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Must be over 18 years of age.
Must be free of other medical conditions that would decrease life expectancy to less that 12 months.
Must be free of Omega 3 supplements or other fish oil containing nutritional supplements for a minimum of two months prior to enrollment.
Must have a ECOG performance status of 0,1 or 2.

Key exclusion criteria (7 listed)

Any life-threatening condition such as (but not limited to) advanced heart disease, kidney or liver failure with an expected survival of less than 12 months.
Any other active malignancy.
Women who are pregnant or lactating.
Individuals unable to give informed consent.
Individuals with known allergy or intolerance to fish oil supplements.

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
Omega 3 Fatty AcidAlso: Res-Q® 1250Omega 3 supplementation will be initiated at three 1250 mg capsules daily for the first month. If dose is well tolerated, it will be increased to six 1250 mg capsules daily for 30 days, and finally to nine 1250 mg capsules daily. Treatment period is 12 months.	Dietary supplement	Omega 3 supplement

Primary outcome

Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.
Time frame: baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)
Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer's protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.
The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.
Time frame: Baseline, month 1, month 2, month 3, month 6, month 9, 12 months
Patients diagnosed with early stage (asymptomatic) CLL were supplemented with escalating doses of omega-3 (n-3) fatty acids (2.4 g of n-3/day up to 7.2 g of n-3/day). Given that these patients are asymptomatic and did not require treatment, measures of tumor mass during and after omega-3 supplementation, as evaluated by standard clinical tests of disease activity, were not performed. Instead, absolute lymphocyte counts (ALC), as a measure of tumor burden, was evaluated before and after omega-3 supplementation. Data represents the fold change in ALC post omega-3 consumption as compared to baseline ALC. Patients with MGUS or SMM were not enrolled into this study.

Results and safety

Results posted to the registry on 18 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omega 3 Supplementation	16	11

Primary outcome: Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.

Time frame: baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement). Mean (Standard Error). Unit: 10^6 NFkB Luminescence units/µg protein

Measure	Baseline Nuclear Factor Kappa B Activation n = 15	Nuclear Factor Kappa B Activation Following 3 Capsules Per Day n = 12	Nuclear Factor Kappa B Activation Following 6 Capsules Per Day n = 12	Nuclear Factor Kappa B Activation Following 9 Capsules Per Day n = 10	Nuclear Factor Kappa B Activation Post Supplement n = 8
Total Population	7.2 (2.25)	4.1 (1.53)	4.2 (1.15)	0.7 (0.94)	1.5 (0.86)
Higher Initial Expressers	12.8 (2.77)	7.4 (2.41)	6.4 (1.42)	0.8 (0.20)	1.6 (1.44)
Lower Initial Expressers	0.8 (0.27)	0.9 (0.37)	1.5 (0.80)	0.6 (0.11)	1.3 (1.16)

Baseline Nuclear Factor Kappa B Activation vs Nuclear Factor Kappa B Activation Following 3 Capsules Per Day: Mean Difference (Final Values): 3.1 (95% CI -5.0 to 11.2), p = 0.78, ANOVA
Baseline Nuclear Factor Kappa B Activation vs Nuclear Factor Kappa B Activation Following 6 Capsules Per Day: Mean Difference (Final Values): 3.0 (95% CI -4.6 to 10.7), p = 0.75, ANOVA
Baseline Nuclear Factor Kappa B Activation vs Nuclear Factor Kappa B Activation Following 9 Capsules Per Day: Mean Difference (Final Values): 6.6 (95% CI -0.6 to 13.7), p = 0.08, ANOVA

Population analysed: NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (\> median, n=7) and low initial baseline (\< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods

Primary outcome: The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.

Time frame: Baseline, month 1, month 2, month 3, month 6, month 9, 12 months. Number. Unit: Fold Change

Measure	Fold Change in ALC-Patient 1 n = 1	Fold Change in ALC-Patient 2 n = 1	Fold Change in ALC-Patient 3 n = 1	Fold Change in ALC-Patient 4 n = 1	Fold Change in ALC-Patient 5 n = 1	Fold Change in ALC-Patient 6 n = 1	Fold Change in ALC-Patient 7 n = 1	Fold Change in ALC-Patient 8 n = 1	Fold Change in ALC-Patient 9 n = 1	Fold Change in ALC-Patient 10 n = 1	Fold Change in ALC-Patient 11 n = 1	Fold Change in ALC-Patient 13 n = 1	Fold Change in ALC-Patient 14 n = 1
Value	1.62	1.71	0.78	0.96	1.32	1.08	1.00	0.92	1.49	1.05	1.16	1.03	1.22

Population analysed: Patients who's absolute lymphocyte counts were known prior to omega-3 initiation (baseline) and after omega-3 consumption were included in this analysis. Patients who's ALC was unknown prior to omega-3 initiation or after omega-3 consumption were excluded.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adverse Effects	0 of 16 (0%)	5 of 16 (31.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20307284Witte TR, Salazar AJ, Ballester OF, Hardman WE. RBC and WBC fatty acid composition following consumption of an omega 3 supplement: lessons for future clinical trials. Lipids Health Dis. 2010 Mar 22;9:31. doi: 10.1186/1476-511X-9-31.

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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.

Wanda E Hardman, Ph.D. principal investigator

Professor Marshall University School of Medicine

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 Omega 3 Fatty Acid in people with Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma, run by Marshall University 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 4 inclusion and 7 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 12 Dec 2013. 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. 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 18 Nov 2013). 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?

Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement. (time frame: baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00899353, which also lists 1 linked publication.

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 12 Dec 2013.