Advanced CancerPhase 2NCT00684242
Lenalidomide (Revlimid) for the Treatment of Refractory Cancer Pain
A Phase 2 study testing Lenalidomide in people with Advanced Cancer and Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if lenalidomide can help to treat uncontrolled pain caused by advanced cancer. Primary Objectives: 1. Determine efficacy of Lenalidomide for the treatment of refractory cancer pain, as measured by the change on Edmonton symptom assessment scale (ESAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Pain
- What is being tested?
- Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Oct 2011
- 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 advanced cancer with a diagnosis of refractory cancer pain (Refractory cancer pain is defined for research purposes as the pain secondary to cancer that is refractory to strong opioids as determined by the persistence of pain despite at least 2 or more opioid escalation and/ or opioid rotations for a given pain syndrome).
- Pain intensity score of 5 or greater on Edmonton Symptom Assessment scale.
- Understand and voluntarily sign an informed consent form.
- Age >/=18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Patients who are receiving chemotherapy are eligible for study if approved by primary oncologist. The PI or enrolling physician will obtain and document approval from the primary oncologist in the patient's study documents.
Show all 12Show fewer
- Will consent to the use of asprin (81 or 325 mg) or Low molecular weight heparin (if intolerant to to asprin)
- Laboratory test results within these ranges within the past 14 days: Absolute neutrophil count >/= 1.5 * 10^9/L , Platelet count >/= 100 * 10^9/L, Serum creatinine </= 2.0 mg/dL, Total bilirubin </=1.5 mg/dL, and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) </=2 * Upper limit of normal (ULN) or </= 5 * ULN if hepatic metastases are present.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- Females of childbearing potential (FCBP). A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.
- FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix : Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- A history of development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Show all 14Show fewer
- Any prior use of lenalidomide.
- Concomitant use of sargramostim (GM-CSF), including radiation, thalidomide, or other investigational agents is not permitted while subjects are receiving study drug during the treatment portion of the study.
- Known positive for HIV or infectious hepatitis, type A, B or C.
- Patients with known myeloid malignancy or tumors having bone marrow involvement.
- History of alcohol abuse as determined by the CAGE questionnaire (> / = 2/4).
- Individual with clinically evident impaired cognition.
- Patient with a history of psychiatric diagnosis of depression or clinical diagnosis of depression as determined by the treating physician or Hospital Anxiety Depression Scale total score of 13 or greater.
- All major surgeries such as thoracotomy etc., that requires wound healing within last 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Clinical Trial of Lenalidomide (Revlimid®) for the Treatment of Refractory Cancer Pain
The goal of this clinical research study is to learn if lenalidomide can help to treat uncontrolled pain caused by advanced cancer.
Primary Objectives:
Read more
- Determine efficacy of Lenalidomide for the treatment of refractory cancer pain, as measured by the change on Edmonton symptom assessment scale (ESAS).
Secondary Objectives:
- To determine the effect of Lenalidomide on fatigue, sleep, depressed mood, nausea and appetite/anorexia.
- Determine changes in serum levels of inflammatory cytokines (IL-1beta, IL-6, TNF-alpha, interferon(IFN)-alpha and IFN-gamma, and C-reactive protein) before and after treatment with Lenalidomide.
- Effect of Lenalidomide on T-cell subsets especially T-regulatory cells
- Effect of Lenalidomide on the expression of costimulatory receptors, CD80, CD86, and CD40, on myeloid and plasmacytoid dendritic cells
- Safety (type, frequency, severity, and relationship of adverse events to study treatment)
Read the detailed description
The Study Drug:
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. The drug is also designed to decrease the level of certain proteins in the blood called cytokines, which may result in decreased pain.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take lenalidomide capsules each morning, with or without food. Take lenalidomide capsules whole, with a 4-ounce (1/2 cup) glass of water at the same time each day. Do not break, chew, or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).
If you take too much lenalidomide, call your study doctor or health care provider or poison control center right away.
You will also be allowed to take strong pain killers such as morphine as prescribed by your study doctor for pain. If you need more than 3 doses of these pain killers in a 24-hour period, you should call your study doctor.
Study Visits:
You will visit the clinic throughout the study. At each visit, you will be asked to return any unused study drug and empty bottles to the clinic and you will be asked about any side effects you may be experiencing. The last study visit will be on Day 43 or Day 57, depending on the side effects you may experience. The following tests and procedures will be performed:
On Day 8:
Blood (about 1 tablespoon) will be drawn for routine tests and women who are able to have children will have a blood pregnancy test.
Day 15:
Blood (about 1 tablespoon) will be drawn for routine tests. Women who are able to have children will have a blood (1-2 teaspoons) pregnancy test. You will complete 5 questionnaires about the pain, the pain symptoms, and any side effects you may be having. The questionnaires will take about 30 to 40 minutes to complete. Women who are able to have children will have a blood pregnancy test.
Day 22:
Blood (about 1 tablespoon) will be drawn for routine tests. Women who are able to have children will have a blood (1-2 teaspoons) pregnancy test.
Day 29:
You will complete the same questionnaires as on Day 15. Women who are able to have children will have a blood pregnancy test and will be counseled about pregnancy precautions and risks. Blood (about 1 tablespoon) will be drawn for routine tests. Women who are able to have children will have a blood (1-2 teaspoons) pregnancy test.
Day 36:
Blood (about 1 tablespoon) will be drawn for routine tests.
Day 43:
Blood (about 1 tablespoon) will be drawn for routine tests. You will complete the same questionnaires as on Day 15. If this is your last visit, you will have an ECG. Women who are able to have children will have a blood (1-2 teaspoons) pregnancy test.
Day 57 (if necessary):
You will complete the same questionnaires as on Day 15. Blood (about 1 tablespoon) will be drawn for routine tests. You will complete the same questionnaires as on Day 15. If this is your last visit, you will have an ECG. Women who are able to have children will have a blood (1-2 teaspoons) pregnancy test.
Day 71 (if necessary):
If you stopped taking the drug on Day 57, a blood (1-2 teaspoons) pregnancy test will be done.
Length of Study:
You may take lenalidomide for up to 57 days. You will be taken off study if the disease gets worse or if intolerable side effects occur.
If you are a female who is able to have children and you do take lenalidomide for all 57 days, you will be required to have a blood (1-2 teaspoons) pregnancy test 28 days after your last dose of lenalidomide.
The routine blood draws on Days 8, 22, and 36 may done at your home (by a study nurse), local doctor's office, or at M. D. Anderson.
All patients who were on lenalidomide and then stopped taking it, will be checked every 3 to 5 weeks for a period of 1 year. During the follow-up visits, certain tests and procedures will be performed. These include a symptom questionnaire, blood draw for routine tests, a check of your side effects, and pregnancy testing for women who are still able to become pregnant. These are the same tests that were done while you were on the study.
Daily Drug Diary and Questionnaire:
Starting on Day 1 until the end of the study, you will complete a questionnaire once daily about any symptoms and pain you may be experiencing. It will take about 5 minutes to complete each time. You will also be provided with a drug diary to write down when and how often you take pain medication. You should bring your completed diary to each study visit so it can be reviewed by the research nurse.
Phone Call Follow-up:
You will be contacted by telephone at home to be asked questions about your symptoms and any side effects you may have experienced. You will be called on Day 8 (plus or minus 3 days), Day 22 (plus or minus 3 days) and Day 36 (plus or minus 3 days). The phone calls will last about 10-15 minutes each time.
End-of-Study Visit:
You will come to the clinic 28 days after your last dose of lenalidomide for a follow-up visit. You will be checked for side effects, and women who are able to have children must have a negative blood (1-2 teaspoons) pregnancy test.
This is an investigational study. Lenalidomide is approved by FDA for the treatment of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM). Lenalidomide is not FDA approved for pain relief. Its use in this study is investigational. If you experience intolerable pain after you stop receiving the study drug, you will be allowed to start receiving lenalidomide (off study). You will be monitored for side effects for every 2-3 weeks while you are on this medication for a period of 1 year. Up to 15 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancer, Pain
- Being tested
- Lenalidomide
- Keywords
- Advanced Cancer, Refractory Cancer Pain, Lenalidomide, Revlimid, CC-5103
- Medical subject headings
- Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid, CC-5103
10 mg by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | 10 mg by mouth daily Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS)
Changes in cancer pain from baseline to day 15 using ESAS to measure participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Intensity of symptoms rated on a 0 to 10 scale from 0 "no symptom" to 10 "worst possible symptom."
Measured: From baseline to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Low accrual.
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 Advanced CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Sriram Yennurajalingam, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684242
- Sponsor's protocol ID
- 2006-0750
- Status last verified
- Dec 2012
- First submitted
- 22 May 2008
- Last updated
- 28 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of Lenalidomide (Revlimid®) for the Treatment of Refractory Cancer Pain
- ClinicalTrials.gov ID
- NCT00684242
- Acronym / sponsor ID
- 2006-0750
- Conditions
- Advanced Cancer, Pain
- Keywords
- Advanced Cancer, Refractory Cancer Pain, Lenalidomide, Revlimid, CC-5103
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- May 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 28 Jan 2013
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 lenalidomide can help to treat uncontrolled pain caused by advanced cancer.
Primary Objectives:
- Determine efficacy of Lenalidomide for the treatment of refractory cancer pain, as measured by the change on Edmonton symptom assessment scale (ESAS).
Secondary Objectives:
- To determine the effect of Lenalidomide on fatigue, sleep, depressed mood, nausea and appetite/anorexia.
- Determine changes in serum levels of inflammatory cytokines (IL-1beta, IL-6, TNF-alpha, interferon(IFN)-alpha and IFN-gamma, and C-reactive protein) before and after treatment with Lenalidomide.
- Effect of Lenalidomide on T-cell subsets especially T-regulatory cells
- Effect of Lenalidomide on the expression of costimulatory receptors, CD80, CD86, and CD40, on myeloid and plasmacytoid dendritic cells
- Safety (type, frequency, severity, and relationship of adverse events to study treatment)
Detailed description
The Study Drug:
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. The drug is also designed to decrease the level of certain proteins in the blood called cytokines, which may result in decreased pain.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take lenalidomide capsules each morning, with or without food. Take lenalidomide capsules whole, with a 4-ounce (1/2 cup) glass of water at the same time each day. Do not break, chew, or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).
If you take too much lenalidomide, call your study doctor or health care provider or poison control center right away.
You will also be allowed to take strong pain killers such as morphine as prescribed by your study doctor for pain. If you need more than 3 doses of these pain killers in a 24-hour period, you should call your study doctor.
Study Visits:
You will visit the clinic throughout the study. At each visit, you will be asked to return any unused study drug and empty bottles to the clinic and you will be asked about any side effects you may be experiencing. The last study visit will be on Day 43 or Day 57, depending on the side effects you may experience. The following tests and procedures will be performed:
On Day 8:
Blood (about 1 tablespoon) will be drawn for routine tests and women who are able to have children will have a blood pregnancy test.
Day 15:
Blood (about 1 tablespoon) will be drawn for routine tests. Women who are able to have children will have a blood (1-2 teaspoons) pregnancy test. You will complete 5 questionnaires about the pain, the pain symptoms, and any side effects you may be having. The questionnaires will take about 30 to 40 minutes to complete. Women who are able to have children will have a blood pregnancy test.
Day 22:
Blood (about 1 tablespoon) will be drawn for routine tests. Women who are able to have children will have a blood (1-2 teaspoons) pregnancy test.
Day 29:
You will complete the same questionnaires as on Day 15. Women who are able to have children will have a blood pregnancy test and will be counseled about pregnancy precautions and risks. Blood (about 1 tablespoon) will be drawn for routine tests. Women who are able to have children will have a blood (1-2 teaspoons) pregnancy test.
Day 36:
Blood (about 1 tablespoon) will be drawn for routine tests.
Day 43:
Blood (about 1 tablespoon) will be drawn for routine tests. You will complete the same questionnaires as on Day 15. If this is your last visit, you will have an ECG. Women who are able to have children will have a blood (1-2 teaspoons) pregnancy test.
Day 57 (if necessary):
You will complete the same questionnaires as on Day 15. Blood (about 1 tablespoon) will be drawn for routine tests. You will complete the same questionnaires as on Day 15. If this is your last visit, you will have an ECG. Women who are able to have children will have a blood (1-2 teaspoons) pregnancy test.
Day 71 (if necessary):
If you stopped taking the drug on Day 57, a blood (1-2 teaspoons) pregnancy test will be done.
Length of Study:
You may take lenalidomide for up to 57 days. You will be taken off study if the disease gets worse or if intolerable side effects occur.
If you are a female who is able to have children and you do take lenalidomide for all 57 days, you will be required to have a blood (1-2 teaspoons) pregnancy test 28 days after your last dose of lenalidomide.
The routine blood draws on Days 8, 22, and 36 may done at your home (by a study nurse), local doctor's office, or at M. D. Anderson.
All patients who were on lenalidomide and then stopped taking it, will be checked every 3 to 5 weeks for a period of 1 year. During the follow-up visits, certain tests and procedures will be performed. These include a symptom questionnaire, blood draw for routine tests, a check of your side effects, and pregnancy testing for women who are still able to become pregnant. These are the same tests that were done while you were on the study.
Daily Drug Diary and Questionnaire:
Starting on Day 1 until the end of the study, you will complete a questionnaire once daily about any symptoms and pain you may be experiencing. It will take about 5 minutes to complete each time. You will also be provided with a drug diary to write down when and how often you take pain medication. You should bring your completed diary to each study visit so it can be reviewed by the research nurse.
Phone Call Follow-up:
You will be contacted by telephone at home to be asked questions about your symptoms and any side effects you may have experienced. You will be called on Day 8 (plus or minus 3 days), Day 22 (plus or minus 3 days) and Day 36 (plus or minus 3 days). The phone calls will last about 10-15 minutes each time.
End-of-Study Visit:
You will come to the clinic 28 days after your last dose of lenalidomide for a follow-up visit. You will be checked for side effects, and women who are able to have children must have a negative blood (1-2 teaspoons) pregnancy test.
This is an investigational study. Lenalidomide is approved by FDA for the treatment of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM). Lenalidomide is not FDA approved for pain relief. Its use in this study is investigational. If you experience intolerable pain after you stop receiving the study drug, you will be allowed to start receiving lenalidomide (off study). You will be monitored for side effects for every 2-3 weeks while you are on this medication for a period of 1 year. Up to 15 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: Lenalidomide10 mg by mouth daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with advanced cancer with a diagnosis of refractory cancer pain (Refractory cancer pain is defined for research purposes as the pain secondary to cancer that is refractory to strong opioids as determined by the persistence of pain despite at least 2 or more opioid escalation and/ or opioid rotations for a given pain syndrome).
- Pain intensity score of 5 or greater on Edmonton Symptom Assessment scale.
- Understand and voluntarily sign an informed consent form.
- Age >/=18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (14 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
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 |
|---|---|---|
| LenalidomideAlso: Revlimid, CC-510310 mg by mouth daily | Drug | Lenalidomide |
Primary outcome
Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS)
Time frame: From baseline to Day 15
Changes in cancer pain from baseline to day 15 using ESAS to measure participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Intensity of symptoms rated on a 0 to 10 scale from 0 "no symptom" to 10 "worst possible symptom."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
Sriram Yennurajalingam, MD principal investigator
M.D. Anderson 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 Lenalidomide in people with Advanced Cancer and Pain, run by M.D. Anderson Cancer Center 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 12 inclusion and 14 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 28 Jan 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 28 Jan 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?
Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS) (time frame: From baseline to Day 15). 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 28 Jan 2013.