MyelomaNCT01927718
Thalidomide to Overcome Lenalidomide Resistance After Autologous Hematopoietic Stem Cell Transplantation (HCT)
A study testing Thalidomide, Lenalidomide and Questionnaires in people with Myeloma, 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 adding low dose Thalidomide (thalidomide) to Revlimid (lenalidomide) maintenance therapy will help control MM after an autologous stem cell transplant. Researchers also want to learn if treatment with these study drugs will improve participants' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- Thalidomide, Lenalidomide and Questionnaires
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 2016
- Phase
- Interventional
- 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
- Patient or legally authorized representative able to sign an informed consent form.
- Age 18 years old or older.
- Multiple myeloma showing signs of biochemical progression while taking lenalidomide or lenalidomide plus dexamethasone maintenance therapy after autologous hematopoietic stem cell transplantation. (Progression is defined solely based on serum or urine M-protein, or in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved serum free light chain level -- please also see appendix E for full details.)
- Patients with biochemical progression only with at least >/= 25% increase from the baseline in any of the following parameters on at least 2 occasions; and when the treating physician deems a change in therapy is necessary: a. Serum M-protein; b. Urine M-protein; or, c. In patients without measureable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels.
- Lenalidomide must have been used for at least 6 months after autologous hematopoietic stem cell transplantation with the current dose of Lenalidomide 15 mg/day or less.
- Serum creatinine clearance (Cockcroft-Gault Equation) >= 50 mL/minute.
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- Performance score of at least 80% by Karnofsky or 0 to 2 Eastern Cooperative Oncology Group (ECOG).
- Patients must be informed of the Celgene Risk Management Program and mandatory registration as well as be willing and able to comply with its requirements.
- Negative Beta Human Chorionic Gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to ongoing pregnancy testing while on treatment with lenalidomide.
- Woman with child bearing potential 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.
- Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy.
- Laboratory test results within these ranges: a. Absolute neutrophil count > 1000 cells/mm3. b. Platelet count > 50,000 cells/mm3 for patients with < 50% of bone marrow plasma cells OR platelet count > 25,000 cells/mm3 for patients in whom > 50% of the bone marrow nucleated cells were plasma cells. c. Total bilirubin </= 2.0 mg/dL. d. AST (SGOT) and ALT (AGPT) </= 3 x upper normal limit.
- Able to take anticoagulation, warfarin or equivalent agent, as detailed in the treatment plan.
- HIV negative.
Who cannot join
- Any serious medical condition or psychiatric illness that would prevent the subject from signing the informed consent form.
- Patients with symptomatic relapse, including those with new bone lesions, soft tissue plasmacytomas, an increase in the size of existing bone lesions or soft tissue plasmacytomas, decrease in hemoglobin, rise in serum creatinine or hypercalcemia.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Known hypersensitivity to thalidomide or lenalidomide.
- Known history of resistance to Thalidomide.
- Patients with grade III-IV neuropathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Pilot Study of Thalidomide to Overcome Lenalidomide Resistance in Patients Suffering Biochemical Progression on Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
The goal of this clinical research study is to learn if adding low dose Thalidomide (thalidomide) to Revlimid (lenalidomide) maintenance therapy will help control MM after an autologous stem cell transplant. Researchers also want to learn if treatment with these study drugs will improve participants' quality of life.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will begin taking lenalidomide and thalidomide by mouth once a day, in the evening. Thalidomide should be taken at least 1 hour after your evening meal. Bedtime is the best time to take thalidomide.
Swallow the lenalidomide and thalidomide capsules whole with at least 4 ounces of water. Do not open, crush, or break the lenalidomide or thalidomide capsules. If you touch a broken lenalidomide or thalidomide capsule, wash the affected area of your body with soap and water.
If you miss a dose of lenalidomide and/or thalidomide, and it has been less than 12 hours since your regular dosing time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.
If you take too much lenalidomide and/or thalidomide (overdose), call your primary healthcare provider or poison control center right away.
If you vomit after taking your dose, you should wait to take another dose until the next scheduled time.
You will be given a patient study drug diary. You will use this diary to write down what time you took each dose of lenalidomide and thalidomide. You need to bring the study drug diary to every study visit so the study staff can review it.
Since lenalidomide and thalidomide both increase the risk of developing blood clots, especially in patients who are at high risk or with a history of blood clots, you may receive heparin, warfarin, or aspirin to help prevent blood clots. Your doctor will decide which medication you need, or your doctor may decide that you do not need a medication to help prevent blood clots, based on your platelet count (cells that help your blood clot).
You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
Study Visits:
Once a month for the first 6 months:
- You will have a physical exam.
- You will have a neurological exam (tests to check the functioning of your nerves, including tests of your balance and reflexes). You will be asked about any numbness or tingling you may be experiencing.
- Blood (about 2 tablespoons) and urine will be collected for routine tests, liver and kidney function tests, blood clotting tests (if needed), and tests to check the status of the disease.
If the doctor thinks the disease has either gone into remission (gotten better) or has gotten worse, you will have additional blood tests and a bone marrow biopsy to check the status of the disease.
After Month 6, during every even-numbered month you are on study (Months 8, 10, 12, and so on), blood (about 2 tablespoons) and urine will be collected for routine tests and to check the status of the disease.
Questionnaires:
You will be asked to complete a questionnaire about your symptoms and quality of life during screening, once a month for the first 6 months, and then every other month while you are on study.
You will sometimes fill out the questionnaire by hand on a piece of paper, or you may be asked the questions over the telephone by a member of the study staff. Other times, the questionnaire will be done over the phone with an automated phone system. The telephone system will ask you to rate how strong and tolerable the symptoms are, and how much the symptoms interfere with your daily life. Rating your symptoms using the telephone system should take less than 5 minutes for each call. The research nurse will teach you how to use the automated telephone system.
Length of Treatment:
You will receive the study drugs for up to 2 years. You will no longer be able to take the study drug if the doctor thinks it is in your best interest, if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions or keep appointments.
Your participation on the study will be over after the end-of-study visit.
End-of-Study Visit:
About 30 days of your last dose of study drugs:
- You will have a physical exam and neurological exam.
- Blood (about 2 tablespoons) and urine will be collected for routine tests and to check the status of the disease.
- You will have a bone marrow biopsy to check the status of the disease, if your doctor thinks it is needed.
This is an investigational study. Lenalidomide and Thalidomide are FDA approved and commercially available for the treatment of myeloma. The use of these chemotherapy drugs in treating MM that has gotten worse after treatment with lenalidomide is considered investigational. The study doctor can explain how the study drug(s) are designed to work.
Up to 17 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Myeloma
- Being tested
- Thalidomide, Lenalidomide, Questionnaires
- Keywords
- Blood And Marrow Transplantation, Myeloma, Multiple myeloma, MM, Autologous stem cell transplantation, ASCT, Thalidomide, Thalomid, Lenalidomide, CC-5013, Revlimid, Questionnaires, Surveys
- Medical subject headings
- Neoplasms, Plasma Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Also called Thalomid
100 mg by mouth daily for 28 days in a 28 day cycle.
LenalidomideDrug
Also called CC-5013, Revlimid
Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 days on a 28 day cycle.
QuestionnairesBehavioural
Also called Surveys
Questionnaire completion at screening, once a month for the first 6 months, then every other month while on study.
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide + Lenalidomide | Experimental | Thalidomide 100 mg by mouth daily for 28 days in a 28 day cycle started after the clinical documentation of biochemical progression.
Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 days on a 28 day cycle. Receives: Drug: Thalidomide; Drug: Lenalidomide; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Response
Primary endpoint is response rate (RR) measured by the proportion of patients receiving the combination, whose disease stabilizes, or returns to at least its previous response level prior to progression, assessed at 3-months after starting the combination.1.Stringent Complete Remission (sCR): Follows criteria for CR, plus:Normal FLC ratio, Absence of clonal cells in the BM; Complete Remission (CR) All of the following criteria are met:Negative SIFE and UIFE:Disappearance of any soft tissue plasmacytomas:< 5% plasma cells in the BM. 2.Very Good Partial Response (VGPR):One or more of the following must be present:Serum and urine M-protein detectable by immunofixation but not on electrophoresis:≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours.Partial Response (PR) Both of the following must be present:≥ 50% reduction in SPEP:Reduction in 24-hour UPEP by ≥ 90% or to < 200 mg/24 hours.3.Stable Disease (SD)Does not meet the criteria for CR, VGPR, PR, or PD.4.Pr
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Poor Response Rate
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- Qaiser Bashir, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927718
- Sponsor's protocol ID
- 2011-0806
- Other IDs
- NCI-2014-00157
- Status last verified
- Apr 2019
- First submitted
- 20 Aug 2013
- Last updated
- 29 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Thalidomide to Overcome Lenalidomide Resistance in Patients Suffering Biochemical Progression on Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01927718
- Acronym / sponsor ID
- 2011-0806
- Conditions
- Myeloma
- Keywords
- Blood And Marrow Transplantation, Myeloma, Multiple myeloma, MM, Autologous stem cell transplantation, ASCT, Thalidomide, Thalomid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor Response Rate
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jan 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Posted 29 Apr 2019
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 adding low dose Thalidomide (thalidomide) to Revlimid (lenalidomide) maintenance therapy will help control MM after an autologous stem cell transplant. Researchers also want to learn if treatment with these study drugs will improve participants' quality of life.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will begin taking lenalidomide and thalidomide by mouth once a day, in the evening. Thalidomide should be taken at least 1 hour after your evening meal. Bedtime is the best time to take thalidomide.
Swallow the lenalidomide and thalidomide capsules whole with at least 4 ounces of water. Do not open, crush, or break the lenalidomide or thalidomide capsules. If you touch a broken lenalidomide or thalidomide capsule, wash the affected area of your body with soap and water.
If you miss a dose of lenalidomide and/or thalidomide, and it has been less than 12 hours since your regular dosing time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.
If you take too much lenalidomide and/or thalidomide (overdose), call your primary healthcare provider or poison control center right away.
If you vomit after taking your dose, you should wait to take another dose until the next scheduled time.
You will be given a patient study drug diary. You will use this diary to write down what time you took each dose of lenalidomide and thalidomide. You need to bring the study drug diary to every study visit so the study staff can review it.
Since lenalidomide and thalidomide both increase the risk of developing blood clots, especially in patients who are at high risk or with a history of blood clots, you may receive heparin, warfarin, or aspirin to help prevent blood clots. Your doctor will decide which medication you need, or your doctor may decide that you do not need a medication to help prevent blood clots, based on your platelet count (cells that help your blood clot).
You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
Study Visits:
Once a month for the first 6 months:
- You will have a physical exam.
- You will have a neurological exam (tests to check the functioning of your nerves, including tests of your balance and reflexes). You will be asked about any numbness or tingling you may be experiencing.
- Blood (about 2 tablespoons) and urine will be collected for routine tests, liver and kidney function tests, blood clotting tests (if needed), and tests to check the status of the disease.
If the doctor thinks the disease has either gone into remission (gotten better) or has gotten worse, you will have additional blood tests and a bone marrow biopsy to check the status of the disease.
After Month 6, during every even-numbered month you are on study (Months 8, 10, 12, and so on), blood (about 2 tablespoons) and urine will be collected for routine tests and to check the status of the disease.
Questionnaires:
You will be asked to complete a questionnaire about your symptoms and quality of life during screening, once a month for the first 6 months, and then every other month while you are on study.
You will sometimes fill out the questionnaire by hand on a piece of paper, or you may be asked the questions over the telephone by a member of the study staff. Other times, the questionnaire will be done over the phone with an automated phone system. The telephone system will ask you to rate how strong and tolerable the symptoms are, and how much the symptoms interfere with your daily life. Rating your symptoms using the telephone system should take less than 5 minutes for each call. The research nurse will teach you how to use the automated telephone system.
Length of Treatment:
You will receive the study drugs for up to 2 years. You will no longer be able to take the study drug if the doctor thinks it is in your best interest, if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions or keep appointments.
Your participation on the study will be over after the end-of-study visit.
End-of-Study Visit:
About 30 days of your last dose of study drugs:
- You will have a physical exam and neurological exam.
- Blood (about 2 tablespoons) and urine will be collected for routine tests and to check the status of the disease.
- You will have a bone marrow biopsy to check the status of the disease, if your doctor thinks it is needed.
This is an investigational study. Lenalidomide and Thalidomide are FDA approved and commercially available for the treatment of myeloma. The use of these chemotherapy drugs in treating MM that has gotten worse after treatment with lenalidomide is considered investigational. The study doctor can explain how the study drug(s) are designed to work.
Up to 17 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalidomide + Lenalidomide | Experimental | Drug: Thalidomide, Drug: Lenalidomide, Behavioral: QuestionnairesThalidomide 100 mg by mouth daily for 28 days in a 28 day cycle started after the clinical documentation of biochemical progression. Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 days on a 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient or legally authorized representative able to sign an informed consent form.
- Age 18 years old or older.
- Multiple myeloma showing signs of biochemical progression while taking lenalidomide or lenalidomide plus dexamethasone maintenance therapy after autologous hematopoietic stem cell transplantation. (Progression is defined solely based on serum or urine M-protein, or in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved serum free light chain level -- please also see appendix E for full details.)
- Patients with biochemical progression only with at least >/= 25% increase from the baseline in any of the following parameters on at least 2 occasions; and when the treating physician deems a change in therapy is necessary: a. Serum M-protein; b. Urine M-protein; or, c. In patients without measureable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels.
- Lenalidomide must have been used for at least 6 months after autologous hematopoietic stem cell transplantation with the current dose of Lenalidomide 15 mg/day or less.
Key exclusion criteria (6 listed)
- Any serious medical condition or psychiatric illness that would prevent the subject from signing the informed consent form.
- Patients with symptomatic relapse, including those with new bone lesions, soft tissue plasmacytomas, an increase in the size of existing bone lesions or soft tissue plasmacytomas, decrease in hemoglobin, rise in serum creatinine or hypercalcemia.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Known hypersensitivity to thalidomide or lenalidomide.
- Known history of resistance 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 |
|---|---|---|
| ThalidomideAlso: Thalomid100 mg by mouth daily for 28 days in a 28 day cycle. | Drug | Thalidomide + Lenalidomide |
| LenalidomideAlso: CC-5013, RevlimidLenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 days on a 28 day cycle. | Drug | Thalidomide + Lenalidomide |
| QuestionnairesAlso: SurveysQuestionnaire completion at screening, once a month for the first 6 months, then every other month while on study. | Behavioural | Thalidomide + Lenalidomide |
Primary outcome
Number of Participants With Response
Time frame: 3 months
Primary endpoint is response rate (RR) measured by the proportion of patients receiving the combination, whose disease stabilizes, or returns to at least its previous response level prior to progression, assessed at 3-months after starting the combination.1.Stringent Complete Remission (sCR): Follows criteria for CR, plus:Normal FLC ratio, Absence of clonal cells in the BM; Complete Remission (CR) All of the following criteria are met:Negative SIFE and UIFE:Disappearance of any soft tissue plasmacytomas:< 5% plasma cells in the BM. 2.Very Good Partial Response (VGPR):One or more of the following must be present:Serum and urine M-protein detectable by immunofixation but not on electrophoresis:≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours.Partial Response (PR) Both of the following must be present:≥ 50% reduction in SPEP:Reduction in 24-hour UPEP by ≥ 90% or to < 200 mg/24 hours.3.Stable Disease (SD)Does not meet the criteria for CR, VGPR, PR, or PD.4.Pr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas 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.
Qaiser Bashir, 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 study testing Thalidomide, Lenalidomide and Questionnaires in people with Myeloma, 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 14 inclusion and 6 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 29 Apr 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 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?
Number of Participants With Response (time frame: 3 months). 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 29 Apr 2019.