Multiple MyelomaPhase 1NCT01750762
Lenalidomide After Allo Transplant
A Phase 1 study testing Lenalidomide in people with Multiple Myeloma and Lymphoma, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This research is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Lymphoma
- What is being tested?
- Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Mar 2014
- Phase
- Phase 1
- 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
- Histologically confirmed multiple myeloma or lymphoma and evidence of disease at least 100 days after an allogeneic stem cell or bone marrow transplantation
- Lymphoma patients must have measurable disease
- No previous cancer therapy within 4 weeks
- Life expectancy of at least 3 months
- Free of prior malignancies for at least 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- Must be registered into RevAssist program and willing and able to comply with RevAssist requirements
- Willing to commit to abstinence or use one highly effective method of birth control and another effective method of birth control at the same time
Who cannot join
- Pregnant or breastfeeding
- Any other serious medical condition
- Any condition that places the subject at unacceptable risk if he/she were to participate in the study
- Use of experimental drug or therapy within 28 days of baseline
- Known significant hypersensitivity to thalidomide or lenalidomide
- Development of erythema nodosum if characterized by desquamating rash while taking thalidomide or similar drugs
Show all 11Show fewer
- Chemotherapy or radiotherapy within 4 weeks
- Known seropositive for acute HIV, hepatitis B or C
- Significant concurrent infections
- Non-hematological acute GvHD and/or hematological toxicity of Grade 3 or higher
- Moderate or severe chronic GVHD
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Phase I Study of Lenalidomide to Augment Anti-Tumor Immunity Following Allogeneic Transplantation
This research is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved lenalidomide for your type of cancer.
Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, this study will determine the effect of lenalidomide on the growth of cancer cells. Lenalidomide is approved by the FDA for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.
Read more
There are some participants with multiple myeloma or lymphoma who have had very long remissions after a bone marrow/stem cell transplantation from another person. This is believed to be the effect of the donor's immune system reaction against the recipient's multiple myeloma cells. It is hoped that due to lenalidomide altering the immune system, it might be able to potentiate that reaction. This study is being done to determine if the use of lenalidomide is safe in transplant participants and if it can facilitate an immune reaction resulting in regression of the myeloma or lymphoma.
During this study you will be evaluated for side effects from the treatment with lenalidomide (including graft versus host disease) and for response of the myeloma to the treatment. There will be two groups of participants in the study. The first group will be treated at a relatively low dose of lenalidomide. If this is found to be safe then the second group will be treated at a higher dose
Read the detailed description
If you agree to participate in this research study you will be asked to undergo some screening tests or procedures to find out if you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: complete medical history, physical examination, blood collection, disease assessment, bone marrow aspirate, electrocardiogram and HIV/Hepatitis blood test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have lenalidomide, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. The total duration of the treatment on this study is 12 weeks or three cycles of 28 days each. At the beginning of each cycle you will receive all the lenalidomide capsules that you will need to take for that cycle. If you take more than the prescribed dose of lenalidomide you should seek emergency medical care if needed and contact study staff immediately. Females of childbearing potential that may be caring for you should not touch the lenalidomide capsules or bottles unless they are wearing gloves.
During the treatment you will be seen in the clinic every two weeks. At every visit the following will be performed: Complete medical history and physical exam, blood collection and research blood testing. If you have myeloma, at the beginning of each cycle you will undergo a disease assessment with blood and urine tests. Any unused Revlimid (lenalidomide) should be returned as instructed through the RevAssist program.
After you have completed taking the drug on the study, the following procedures and tests will take place: Complete medical history and physical examination, blood collection, disease assessment, bone marrow aspirate/biopsy and research blood testing. You will be on the study treatment for about three months and will be followed every three months after your treatment ends for two years.
- Conditions
- Multiple Myeloma, Lymphoma
- Being tested
- Lenalidomide
- Medical subject headings
- Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called revlimid
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Dose escalation. Starting dose is 10 mg/day for 3 weeks followed by 1 week off (1 cycle). Subject will receive a total of 3 cycles. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of lenalidomide
To determine the tolerability (with special attention to acute or chronic GVHD) and maximum tolerated dose (out of either 10 or 15 mg daily) of lenalidomide in patients with multiple myeloma or lymphoma who do not achieve a CR or relapse after an allogeneic SCT.
Measured: 2 years
Secondary outcomes (3)
Effect of lenalidomide on T-cells
To assess the effect of lenalidomide therapy on the prevalence of tumor specific T cells and the presence of activated as compared to suppressor T cells
Measured: 2 years
Effect of lenalidomide on disease response
To assess the effect of lenalidomide therapy on disease response. Clinical response will be correlated with the presence of tumor specific immune response
Measured: 2 years
The effects of lenalidomide on time to progression
To assess the effect of lenalidomide therapy on time to disease progression.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2014
- Study completionMar 2014
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 Beth Israel Deaconess Medical 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Luptakova, Beth Israel Deaconess Medical Center
- Investigators
- Katarina Luptakova, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750762
- Sponsor's protocol ID
- 12-086
- Status last verified
- Apr 2017
- First submitted
- 12 Dec 2012
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Lenalidomide to Augment Anti-Tumor Immunity Following Allogeneic Transplantation
- ClinicalTrials.gov ID
- NCT01750762
- Acronym / sponsor ID
- 12-086
- Conditions
- Multiple Myeloma, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Dec 2012 (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.
This research is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved lenalidomide for your type of cancer.
Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, this study will determine the effect of lenalidomide on the growth of cancer cells. Lenalidomide is approved by the FDA for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.
There are some participants with multiple myeloma or lymphoma who have had very long remissions after a bone marrow/stem cell transplantation from another person. This is believed to be the effect of the donor's immune system reaction against the recipient's multiple myeloma cells. It is hoped that due to lenalidomide altering the immune system, it might be able to potentiate that reaction. This study is being done to determine if the use of lenalidomide is safe in transplant participants and if it can facilitate an immune reaction resulting in regression of the myeloma or lymphoma.
During this study you will be evaluated for side effects from the treatment with lenalidomide (including graft versus host disease) and for response of the myeloma to the treatment. There will be two groups of participants in the study. The first group will be treated at a relatively low dose of lenalidomide. If this is found to be safe then the second group will be treated at a higher dose
Detailed description
If you agree to participate in this research study you will be asked to undergo some screening tests or procedures to find out if you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: complete medical history, physical examination, blood collection, disease assessment, bone marrow aspirate, electrocardiogram and HIV/Hepatitis blood test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have lenalidomide, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. The total duration of the treatment on this study is 12 weeks or three cycles of 28 days each. At the beginning of each cycle you will receive all the lenalidomide capsules that you will need to take for that cycle. If you take more than the prescribed dose of lenalidomide you should seek emergency medical care if needed and contact study staff immediately. Females of childbearing potential that may be caring for you should not touch the lenalidomide capsules or bottles unless they are wearing gloves.
During the treatment you will be seen in the clinic every two weeks. At every visit the following will be performed: Complete medical history and physical exam, blood collection and research blood testing. If you have myeloma, at the beginning of each cycle you will undergo a disease assessment with blood and urine tests. Any unused Revlimid (lenalidomide) should be returned as instructed through the RevAssist program.
After you have completed taking the drug on the study, the following procedures and tests will take place: Complete medical history and physical examination, blood collection, disease assessment, bone marrow aspirate/biopsy and research blood testing. You will be on the study treatment for about three months and will be followed every three months after your treatment ends for two years.
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: LenalidomideDose escalation. Starting dose is 10 mg/day for 3 weeks followed by 1 week off (1 cycle). Subject will receive a total of 3 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed multiple myeloma or lymphoma and evidence of disease at least 100 days after an allogeneic stem cell or bone marrow transplantation
- Lymphoma patients must have measurable disease
- No previous cancer therapy within 4 weeks
- Life expectancy of at least 3 months
- Free of prior malignancies for at least 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding
- Any other serious medical condition
- Any condition that places the subject at unacceptable risk if he/she were to participate in the study
- Use of experimental drug or therapy within 28 days of baseline
- Known significant hypersensitivity to thalidomide or lenalidomide
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 | Drug | Lenalidomide |
Primary outcome
Tolerability of lenalidomide
Time frame: 2 years
To determine the tolerability (with special attention to acute or chronic GVHD) and maximum tolerated dose (out of either 10 or 15 mg daily) of lenalidomide in patients with multiple myeloma or lymphoma who do not achieve a CR or relapse after an allogeneic SCT.
3 secondary outcomes
Effect of lenalidomide on T-cells
Time frame: 2 years
Effect of lenalidomide on disease response
Time frame: 2 years
The effects of lenalidomide on time to progression
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Katarina Luptakova, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenalidomide in people with Multiple Myeloma and Lymphoma, run by Beth Israel Deaconess Medical 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 7 inclusion and 11 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 18 Apr 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early. Results are not available in the source record.
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?
Tolerability of lenalidomide (time frame: 2 years). 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 18 Apr 2017.