Multiple MyelomaPhase 2NCT01269203
Efficacy of NF-kB Inhibition for Reducing Symptoms During Maintenance Therapy in Multiple Myeloma Patients
A Phase 2 study testing Curcumin in people with Multiple Myeloma, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if curcumin can reduce the symptoms reported by patients with multiple myeloma (MM) who receive treatment with lenalidomide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Curcumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 have a histologically confirmed diagnosis of multiple myeloma.
- Must be >/= 18 years of age.
- Must have a performance status (ECOG PS) of 0-2.
- Must be qualified and have signed consent to receive lenalidomide for maintenance therapy for MM.
- Must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.
- Must also agree to refrain from use of self prescribed curcumin during the course of the study.
- Must have negative pregnancy test before signing consent for MM therapy.
Who cannot join
- Unable to understand the symptom assessment or not willing to participate in the study.
- Treatment for other carcinomas within the last 5 years, except for cured non-melanoma skin and treated in-situ cervical cancer.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or requiring IV antibiotics, cardiac disease (NYHA class III or IV heart failure), unstable angina pectoris, unstable cardiac arrhythmia or tachycardia, or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.
- Concurrent use of coumadin other than low dose (1 mg) coumadin used for line patency.
- Concurrent use of cimetidine, allopurinol, or aluminium hydroxide and magnesium hydroxide-containing antacids such as Maalox.
- Sorivudine and brivudine use within 4 weeks of the start of study treatment.
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- Gastric or duodenal ulcers, or gastric hyperacidity disorders.
- Currently receiving anticoagulants (heparin) or antiplatelets (clopidogrel, ticlopidine, aspirin/dipyridamole)
- INR > 1.5 (upper limit of normal = 1.5).
- History of deep vein thrombosis.
- Received allogeneic transplant.
- Allergy to turmeric, Curcumin, or yellow dye.
- Bowel or bile duct obstruction.
About this study
Official title: A Phase II Randomized Study of the Efficacy of Curcumin for Reducing Symptoms During Maintenance Therapy in Multiple Myeloma Patients
The goal of this clinical research study is to learn if curcumin can reduce the symptoms reported by patients with multiple myeloma (MM) who receive treatment with lenalidomide.
Read the detailed description
Curcumin is the active ingredient in the spice turmeric. It may interfere with the production of cytokines (which cause inflammation), which may help reduce multiple symptoms.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take curcumin. Group 2 will take a placebo. You will have an equal chance of being assigned to each group. No matter which group you are in, you will be given standard care by your treating doctor.
Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug Administration:
You will take curcumin/placebo 2 times every day about 12 hours apart. You will begin taking curcumin/placebo when you begin maintenance therapy with lenalidomide.
You will be given a pamphlet with more information about how to take the curcumin/placebo.
You must bring the study capsules you have not yet taken to the clinic every study visit.
Every 4 weeks is called a study cycle.
Study Visits:
Before you begin treatment with lenalidomide and curcumin/placebo:
- You will be taught how to use the automated symptom assessment telephone program.
- You will complete 4 questionnaires about pain and other symptoms, and your quality of life. In addition, some personal information (such as your name, address, race, and smoking history) will be collected. Completing the questionnaires will take about 20 minutes.
- You will be asked about any drugs you may be taking.
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
Telephone System Calls for Symptom Monitoring:
A telephone system will call you once a week at a time convenient to you. Using the numeric key pad on your telephone, you will rate your symptoms and how they interfere with your daily activities. Each phone call will take about 5 minutes to complete. You will be given a brochure explaining the steps to complete the symptom questionnaire and a telephone number to call if you have questions or problems with the telephone system.
At the start of Cycle 4 and at the End of Study Visit:
-You will complete 3 questionnaires about your pain and other symptoms and your quality of life. The questionnaires will take about 20 minutes to complete. If for some reason, you are unable to complete the questionnaire through the automated symptom assessment telephone program, you may be able to complete it with the research staff, either by phone or during a routine clinic visit.
Research staff will talk to you during your regularly scheduled visits for each cycle of treatment with lenalidomide. You will be asked about side effects you may be having and drugs you are taking.
Length of Study:
You will take curcumin/placebo for 6 months. You will remain on the study for about 6-7 months (depending on how your clinic visits are scheduled). You will be taken off study if you have intolerable side effects or the disease gets worse.
This is an investigational study. Curcumin is not FDA approved. At this time, curcumin is only being used in research.
Up to 70 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Multiple Myeloma
- Being tested
- Curcumin, Placebo
- Keywords
- multiple myeloma, MM, maintenance therapy, lenalidomide, bone marrow transplantation, auto-HSCT, Autologous Hematopoietic Stem Cell Transplantation, NF-kB inhibition, reducing symptoms, maintenance chemotherapy, inflammatory cytokines, nuclear factor kappa B, NF-kB, interleukin, IL-6, tumor necrosis factor, TNF-a, NF-kB activation levels
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
1000 mg per day
PlaceboOther
Administered daily same as Curcumin.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Active comparator | 1000 mg/day Curcumin + 5 -15 mg/day Lenalidomide Receives: Drug: Curcumin |
| Placebo | Placebo comparator | Placebo daily + 5 -15 mg/day Lenalidomide Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC from 3 months Post-Transplantation to 9 months Post-Transplantation
Daily area under the curve (AUC) where AUC is based on average of 5 most severe symptoms (pain, fatigue, bone aches, numbness, disturbed sleep) being experienced by MM patients as measured by MDASI-MM, a multiple-symptom measure of cancer-related symptoms rate severity of physical, affective, and cognitive symptoms on 0-10 numeric scales, ranging from 0 "not present" to 10 "as bad as you can imagine."
Measured: Assessments within +/-3 days of 4 week cycle start date for 6 cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startOct 2012
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Robert Orlowski, MD, PhD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269203
- Sponsor's protocol ID
- 2010-0457
- Status last verified
- Sep 2012
- First submitted
- 30 Dec 2010
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of the Efficacy of Curcumin for Reducing Symptoms During Maintenance Therapy in Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT01269203
- Acronym / sponsor ID
- 2010-0457
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, MM, maintenance therapy, lenalidomide, bone marrow transplantation, auto-HSCT, Autologous Hematopoietic Stem Cell Transplantation, NF-kB inhibition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2012
- Primary completion
- Oct 2015 (estimated)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if curcumin can reduce the symptoms reported by patients with multiple myeloma (MM) who receive treatment with lenalidomide.
Detailed description
Curcumin is the active ingredient in the spice turmeric. It may interfere with the production of cytokines (which cause inflammation), which may help reduce multiple symptoms.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take curcumin. Group 2 will take a placebo. You will have an equal chance of being assigned to each group. No matter which group you are in, you will be given standard care by your treating doctor.
Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug Administration:
You will take curcumin/placebo 2 times every day about 12 hours apart. You will begin taking curcumin/placebo when you begin maintenance therapy with lenalidomide.
You will be given a pamphlet with more information about how to take the curcumin/placebo.
You must bring the study capsules you have not yet taken to the clinic every study visit.
Every 4 weeks is called a study cycle.
Study Visits:
Before you begin treatment with lenalidomide and curcumin/placebo:
- You will be taught how to use the automated symptom assessment telephone program.
- You will complete 4 questionnaires about pain and other symptoms, and your quality of life. In addition, some personal information (such as your name, address, race, and smoking history) will be collected. Completing the questionnaires will take about 20 minutes.
- You will be asked about any drugs you may be taking.
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
Telephone System Calls for Symptom Monitoring:
A telephone system will call you once a week at a time convenient to you. Using the numeric key pad on your telephone, you will rate your symptoms and how they interfere with your daily activities. Each phone call will take about 5 minutes to complete. You will be given a brochure explaining the steps to complete the symptom questionnaire and a telephone number to call if you have questions or problems with the telephone system.
At the start of Cycle 4 and at the End of Study Visit:
-You will complete 3 questionnaires about your pain and other symptoms and your quality of life. The questionnaires will take about 20 minutes to complete. If for some reason, you are unable to complete the questionnaire through the automated symptom assessment telephone program, you may be able to complete it with the research staff, either by phone or during a routine clinic visit.
Research staff will talk to you during your regularly scheduled visits for each cycle of treatment with lenalidomide. You will be asked about side effects you may be having and drugs you are taking.
Length of Study:
You will take curcumin/placebo for 6 months. You will remain on the study for about 6-7 months (depending on how your clinic visits are scheduled). You will be taken off study if you have intolerable side effects or the disease gets worse.
This is an investigational study. Curcumin is not FDA approved. At this time, curcumin is only being used in research.
Up to 70 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Active comparator | Drug: Curcumin1000 mg/day Curcumin + 5 -15 mg/day Lenalidomide |
| Placebo | Placebo comparator | Other: PlaceboPlacebo daily + 5 -15 mg/day Lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have a histologically confirmed diagnosis of multiple myeloma.
- Must be >/= 18 years of age.
- Must have a performance status (ECOG PS) of 0-2.
- Must be qualified and have signed consent to receive lenalidomide for maintenance therapy for MM.
- Must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.
Key exclusion criteria (13 listed)
- Unable to understand the symptom assessment or not willing to participate in the study.
- Treatment for other carcinomas within the last 5 years, except for cured non-melanoma skin and treated in-situ cervical cancer.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or requiring IV antibiotics, cardiac disease (NYHA class III or IV heart failure), unstable angina pectoris, unstable cardiac arrhythmia or tachycardia, or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.
- Concurrent use of coumadin other than low dose (1 mg) coumadin used for line patency.
- Concurrent use of cimetidine, allopurinol, or aluminium hydroxide and magnesium hydroxide-containing antacids such as Maalox.
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 |
|---|---|---|
| Curcumin1000 mg per day | Drug | Curcumin |
| PlaceboAdministered daily same as Curcumin. | Other | Placebo |
Primary outcome
AUC from 3 months Post-Transplantation to 9 months Post-Transplantation
Time frame: Assessments within +/-3 days of 4 week cycle start date for 6 cycles.
Daily area under the curve (AUC) where AUC is based on average of 5 most severe symptoms (pain, fatigue, bone aches, numbness, disturbed sleep) being experienced by MM patients as measured by MDASI-MM, a multiple-symptom measure of cancer-related symptoms rate severity of physical, affective, and cognitive symptoms on 0-10 numeric scales, ranging from 0 "not present" to 10 "as bad as you can imagine."
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Robert Orlowski, MD, PhD study chair
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin in people with Multiple Myeloma, run by M.D. Anderson Cancer Center.
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 7 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: withdrawn, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
AUC from 3 months Post-Transplantation to 9 months Post-Transplantation (time frame: Assessments within +/-3 days of 4 week cycle start date for 6 cycles.). 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 7 Sep 2012.