Multiple MyelomaPhase 2NCT01380106
Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma
A Phase 2 study testing Lenalidomide 15mg and Lenalidomide 25mg in people with Multiple Myeloma, run by Boston VA Research Institute, Inc. at 7 sites in United States.
Trial summary
This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in combination with low dose dexamethasone in patients with relapsed multiple myeloma. The investigators propose to use the need for dose reduction as a criterion to judge tolerability from various causes. 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?
- Lenalidomide 15mg and Lenalidomide 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2010to 11 Sep 2017
- 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
- Previously diagnosed with multiple myeloma.
- Must have relapsed or refractory disease (refractory is defined as progression during treatment or within 60 days after the completion of treatment) requiring 2nd or 3rd line therapy
- Patients may have received lenalidomide and/or dexamethasone
- Patients must have measurable disease:
- Serum monoclonal protein >0.5g/dL and/or 0.2g/24hr urine light chain excretion
- Patients with lower M-protein values or non-secretory myeloma will be eligible if measurable disease can be established, such as serum FreeliteTM chain ratio >5x ULN, measurable soft tissue plasmacytoma >2cm by either physical exam and/or applicable radiographs (i.e. MRI, CT-scan) and/or bone marrow involvement >30%
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- Age >=18 years at the time of consent.
- All necessary baseline studies for determining eligibility must be obtained within 14 days prior to enrollment. Serum pregnancy tests (sensitivity of at least 25 mIU/mL), for females of childbearing potential (WCBP) must be completed. The first test must be performed within 10-14 days, and the second test within 24 hours prior to initiation of lenalidomide.
- Pre-study ECOG performance status 0-2. Patients with lower performance status based solely on bone pain will be eligible.
- Adequate liver functions: AST and ALT =< 3xULN, alkaline phosphatase =< 3.0x ULN, except if attributed to tumor, and bilirubin =< 2xULN.
- Have Amylase =< 2.5x ULN
- Able to adhere to the study visit schedule and other protocol requirements
- Must understand and voluntarily sign an informed consent document.
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to and again within 24 hours of starting lenalidomide 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 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. All counseling will be done through RevAssist®.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.
- Patients may receive a bisphosphonate.
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.
- Renal insufficiency of creatinine clearance <40mL/min
- Known hypersensitivity to thalidomide or lenalidomide.
- Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
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- Concurrent use of other anti-cancer agents or treatments.
- Known seropositive for an active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- Has hemoglobin <8.0g/dL. The use of transfusion with pRBC to correct anemia and meet eligibility criteria will not be allowed.
- Has an absolute neutrophil count <1.0x10^9/L within 14 days before enrollment
- Peripheral neuropathy of grade >=3. Patients with painful grade 2 neuropathy are also excluded
- Has platelet count <75x10^9/L within 14 days before enrollment.
- Plasma cell leukemia at time of study entry.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Edward Hines Jr VA Hospital
Hines, Illinois, 60141
Houston VA Medical Center
Houston, Texas, 77030
VA Boston Healthcare System
Jamaica Plain, Massachusetts, 02130
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
West Los Angeles VA Medical Center
Los Angeles, California, 90073
Pittsburgh VA Medical Center
Pittsburgh, Pennsylvania, 15240
About this study
Official title: A Controlled, Parallel-Group, Randomized, Open-Label Study to Evaluate Two Lenalidomide Dose Regimens When Used in Combination With Low Dose Dexamethasone for the Treatment of Subjects With Relapsed Multiple Myeloma
This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in combination with low dose dexamethasone in patients with relapsed multiple myeloma.
The investigators propose to use the need for dose reduction as a criterion to judge tolerability from various causes. In the veteran population which predominantly is in the older age category with number of co-morbidities, a lower dose regimen may be safer and advantageous.
Read more
This study expects to enroll approximately 80 subjects from participating VA sites across the nation.
The investigators will evaluate the safety of the two dose regimens by comparing frequency of dose reductions. The investigators will also measure how long the responses last with each dose.
Lenalidomide is approved by the Food and Drug Administration (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.
At the time of enrollment, one-half of the subjects will be chosen at random to receive the 15 mg Lenalidomide dose and the other half will take the 25 mg dose regimen of Lenalidomide. Depending on lenalidomide treatment assignment, subjects will receive either 15 mg p.o. q.d. or 25 mg p.o. q.d. for days 1-21 of a 28 day cycle. In addition, dexamethasone (40 mg) will be added once a week (Days 1, 8, 15 and 22) to the Lenalidomide regimen, with a dose reduction on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. ASA (81 or 325mg) will be given daily for anticoagulation prophylaxis. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.
Read the detailed description
Primary Objective:
- Evaluate the frequency of dose reductions in two different lenalidomide dose regimens.
Secondary Objectives:
- Evaluate the efficacy of two different lenalidomide dose regimens in patients with multiple myeloma using the EBMT and IMWG criteria.
- Evaluate the duration of response of 15 mg Lenalidomide and 25 mg of Lenalidomide when used in combination with Low Dose Dexamethasone.
- Evaluate the safety of 15 mg and 25 mg of Lenalidomide regiments when in combination with dexamethasone.
- Explore blood and cellular levels of angiogenic factors, cytokines, and adhesion molecules.
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide 15mg, Lenalidomide 25mg
- Keywords
- Multiple myeloma, Relapsed, Revlimid
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide 15mgDrug
Also called REVLIMID®
Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
Lenalidomide 25mgDrug
Also called REVLIMID®
Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide 25mg | Active comparator | Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Receives: Drug: Lenalidomide 25mg |
| Lenalidomide 15mg | Active comparator | Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Receives: Drug: Lenalidomide 15mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Type, frequency, severity and timing of adverse events and their relationship to combination therapy with lenalidomide plus dexamethasone.
SAE Grade 3 indicates a severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization; disabling; limiting self care ADL SAE Grade 4 indicates a life-threatening consequences; urgent intervention indicated.
SAE Grade 5 Death related to AE.
Measured: Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Duration Until Best Response (at Least MR or Minimal Response)
Number of days between the first day of the first cycle to best M-protein response, at least Minimal Response or higher (Partial Response, Very Good Partial Response, near Complete Response, Complete Response).
Measured: Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startAug 2010
- Primary completion11 Sep 2017
- Study completion11 Sep 2017
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 Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston VA Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Kansas City Veteran Affairs Medical Center, VA Pittsburgh Healthcare System, VA Greater Los Angeles Healthcare System, Michael E. DeBakey VA Medical Center, Edward Hines Jr. VA Hospital
- Responsible party
- Principal investigator, Nikhil Munshi, M.D., Boston VA Research Institute, Inc.
- Investigators
- Nikhil C Munshi, M.D., Principal investigator, Boston VA Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380106
- Sponsor's protocol ID
- RV-MM-PI-0345
- Status last verified
- Jan 2021
- First submitted
- 22 Jun 2011
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Parallel-Group, Randomized, Open-Label Study to Evaluate Two Lenalidomide Dose Regimens When Used in Combination With Low Dose Dexamethasone for the Treatment of Subjects With Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01380106
- Acronym / sponsor ID
- RV-MM-PI-0345
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Relapsed, Revlimid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Boston VA Research Institute, Inc.University, hospital or other
- Collaborators
- Celgene Corporation, Kansas City Veteran Affairs Medical Center, VA Pittsburgh Healthcare System, VA Greater Los Angeles Healthcare System, Michael E. DeBakey VA Medical Center, Edward Hines Jr. VA Hospital
- Study start
- Aug 2010
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 25 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in combination with low dose dexamethasone in patients with relapsed multiple myeloma.
The investigators propose to use the need for dose reduction as a criterion to judge tolerability from various causes. In the veteran population which predominantly is in the older age category with number of co-morbidities, a lower dose regimen may be safer and advantageous.
This study expects to enroll approximately 80 subjects from participating VA sites across the nation.
The investigators will evaluate the safety of the two dose regimens by comparing frequency of dose reductions. The investigators will also measure how long the responses last with each dose.
Lenalidomide is approved by the Food and Drug Administration (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.
At the time of enrollment, one-half of the subjects will be chosen at random to receive the 15 mg Lenalidomide dose and the other half will take the 25 mg dose regimen of Lenalidomide. Depending on lenalidomide treatment assignment, subjects will receive either 15 mg p.o. q.d. or 25 mg p.o. q.d. for days 1-21 of a 28 day cycle. In addition, dexamethasone (40 mg) will be added once a week (Days 1, 8, 15 and 22) to the Lenalidomide regimen, with a dose reduction on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. ASA (81 or 325mg) will be given daily for anticoagulation prophylaxis. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.
Detailed description
Primary Objective:
- Evaluate the frequency of dose reductions in two different lenalidomide dose regimens.
Secondary Objectives:
- Evaluate the efficacy of two different lenalidomide dose regimens in patients with multiple myeloma using the EBMT and IMWG criteria.
- Evaluate the duration of response of 15 mg Lenalidomide and 25 mg of Lenalidomide when used in combination with Low Dose Dexamethasone.
- Evaluate the safety of 15 mg and 25 mg of Lenalidomide regiments when in combination with dexamethasone.
- Explore blood and cellular levels of angiogenic factors, cytokines, and adhesion molecules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide 25mg | Active comparator | Drug: Lenalidomide 25mgSubjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle |
| Lenalidomide 15mg | Active comparator | Drug: Lenalidomide 15mgSubjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Previously diagnosed with multiple myeloma.
- Must have relapsed or refractory disease (refractory is defined as progression during treatment or within 60 days after the completion of treatment) requiring 2nd or 3rd line therapy
- Patients may have received lenalidomide and/or dexamethasone
- Patients must have measurable disease:
- Age >=18 years at the time of consent.
Key exclusion criteria (13 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.
- Renal insufficiency of creatinine clearance <40mL/min
- Known 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 |
|---|---|---|
| Lenalidomide 15mgAlso: REVLIMID®Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle. | Drug | Lenalidomide 15mg |
| Lenalidomide 25mgAlso: REVLIMID®Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle | Drug | Lenalidomide 25mg |
Primary outcome
Serious Adverse Events
Time frame: Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Type, frequency, severity and timing of adverse events and their relationship to combination therapy with lenalidomide plus dexamethasone. SAE Grade 3 indicates a severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization; disabling; limiting self care ADL SAE Grade 4 indicates a life-threatening consequences; urgent intervention indicated. SAE Grade 5 Death related to AE.
Duration Until Best Response (at Least MR or Minimal Response)
Time frame: Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Number of days between the first day of the first cycle to best M-protein response, at least Minimal Response or higher (Partial Response, Very Good Partial Response, near Complete Response, Complete Response).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Nikhil C Munshi, M.D. principal investigator
Boston VA Research Institute, Inc.
7 sites 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 15mg and Lenalidomide 25mg in people with Multiple Myeloma, run by Boston VA Research Institute, Inc. at 7 sites 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 17 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: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 25 Jan 2021). 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?
Serious Adverse Events (time frame: Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2021.