Multiple MyelomaPhase 4NCT01731886
Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma
A Phase 4 study testing Autologous peripheral blood stem cell transplant, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Columbia University at 1 site in United States.
Trial summary
The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. 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?
- Autologous peripheral blood stem cell transplant, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 11 Apr 2017
- Phase
- Phase 4
- 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
- Histologically or cytologically confirmed Multiple Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that has not been previously treated.
- Bone marrow plasmacytosis with > or = 10% plasma cells, or sheets of plasma cells or a biopsy-proven plasmacytoma.
- Measurable levels of monoclonal protein (M protein): 1 g/dL Immunoglobulin G (IgG) or .5 g/dL Immunoglobulin A (IgA) on serum protein electrophoresis or > 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis.
- Age > or = 18 years.
- Life expectancy of greater than 12 months.
- Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or = 60%).
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- Adequate organ and marrow function as defined below:
- Hgb > or = 9 g/dL
- Absolute Neutrophil Count > or = 1,500/ ml
- Platelets > or = 50,000/mm3
- Total Bilirubin < or = 1.5 mg/dL
- Aspartate aminotransferase (AST)(SGOT) / alanine aminotransferase (ALT)(SGPT) < or = 2.5 X upper limit of normal (ULN)
- Creatinine < 2.0 mg/dL
- Creatinine Clearance > or = 50 ml/min
- Registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
- Ability to understand and the willingness to sign a written informed consent document.
- Subjects with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months.
- Must be willing and able to take prophylaxis with either aspirin at 81 mg/day or alternative prophylaxis with either low molecular weight heparin or warfarin as recommended.
- Eligible for transplant with an age up to and including 75 years.
- Subjects in Arm A who are refusing transplant can go onto Arm B and will be evaluated separately.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-international units per millilitre (mIU/mL) within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence or 2 acceptable methods of birth control. FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex condom.
Who cannot join
- Have had chemotherapy or radiotherapy for multiple myeloma within 4 weeks of baseline.
- Receiving any other investigational agents or therapy within 28 days of baseline.
- Brain metastases.
- Subjects who are pregnant or breast feeding.
- History of previous deep vein thrombosis or pulmonary embolism must be on anticoagulation therapy with low molecular weight heparin or warfarin at therapeutic dosages (e.g. International Normalized Ratio (INR) 2-3).
- If a subject is on full-dose anticoagulants, the following criteria should be met for enrollment:
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- Must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices).
- Must not have thrombocytopenia requiring transfusion.
- Must have a platelet count > 50,000.
- Must have stable INR between 2-3.
- Smoldering myeloma or monoclonal gammopathy of undetermined significance.
- Active, uncontrolled infection.
- Active, uncontrolled seizure disorder (seizures in the last 6 months).
- Concurrent use of other anti-cancer agents or treatments.
- Positive for HIV or infectious hepatitis, type B or C.
- Hypersensitivity to thalidomide.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma
The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.
Read the detailed description
Multiple myeloma is a malignant plasma cell proliferative disorder responsible for 11, 000 deaths each year in the United States. Approximately one third of myeloma patients develop hypercalcemia and about two thirds present with anemia. As the second most common hematologic malignancy, myeloma remains incurable. In the last forty years, options for therapy have included melphalan-prednisone, anthracyclines, and vinca alkaloids; however, relapse with those regimens continues to be inevitable with a median survival of 3 years.
- Conditions
- Multiple Myeloma
- Being tested
- Autologous peripheral blood stem cell transplant, Lenalidomide, Dexamethasone, Stem cell collection, Melphalan
- Keywords
- Stem cell transplant, plasma cell myeloma, multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous peripheral blood stem cell transplantProcedure or surgery
Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.
LenalidomideDrug
Also called CC-5013, Revlimid
Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
DexamethasoneDrug
Also called Decadron, Hexadrol, Dexameth, Dexone
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
Stem cell collectionProcedure or surgery
Also called Stem Cell Mobilization
Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.
MelphalanDrug
Also called Evomela
Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.
G-CSFDrug
Also called Granulocyte-colony stimulating factor (CSF), Filgrastim
Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.
CyclophosphamideDrug
Also called Cytophosphane
Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
MesnaDrug
Also called Mesnex
Mesna will be provided with the cyclophosphamide.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by steam cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Receives: Procedure: Autologous peripheral blood stem cell transplant; Drug: Lenalidomide; Drug: Dexamethasone; Procedure: Stem cell collection; Drug: Melphalan; Drug: G-CSF; Drug: Cyclophosphamide; Drug: Mesna |
| Arm B | Active comparator | Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Receives: Drug: Lenalidomide; Drug: Dexamethasone; Procedure: Stem cell collection; Drug: Cyclophosphamide; Drug: Mesna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).
Measured: 3 years
Secondary outcomes (4)
Overall Survival Rate (OS)
To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
Measured: 4 years
Overall Survival Rate (OS)
To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
Measured: 2 years
Progression Free Survival (PFS)
PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Measured: 4 years
Progression Free Survival (PFS)
PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
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 posted22 Nov 2012 (estimated)
- Study startSep 2012
- Primary completion11 Apr 2017
- Study completion11 Apr 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.
- More trials run by Columbia UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Lentzsch, MD, Columbia University
- Investigators
- Suzanne Lentzsch, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731886
- Sponsor's protocol ID
- AAAJ2355
- Status last verified
- Jan 2020
- First submitted
- 19 Nov 2012
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be coded and shared with the University of Pittsburgh at the end of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01731886
- Acronym / sponsor ID
- AAAJ2355
- Conditions
- Multiple Myeloma
- Keywords
- Stem cell transplant, plasma cell myeloma, multiple myeloma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Posted 15 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.
Detailed description
Multiple myeloma is a malignant plasma cell proliferative disorder responsible for 11, 000 deaths each year in the United States. Approximately one third of myeloma patients develop hypercalcemia and about two thirds present with anemia. As the second most common hematologic malignancy, myeloma remains incurable. In the last forty years, options for therapy have included melphalan-prednisone, anthracyclines, and vinca alkaloids; however, relapse with those regimens continues to be inevitable with a median survival of 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Procedure: Autologous peripheral blood stem cell transplant, Drug: Lenalidomide, Drug: Dexamethasone, Procedure: Stem cell collection, Drug: Melphalan, Drug: G-CSF, Drug: Cyclophosphamide, Drug: MesnaSubjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by steam cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). |
| Arm B | Active comparator | Drug: Lenalidomide, Drug: Dexamethasone, Procedure: Stem cell collection, Drug: Cyclophosphamide, Drug: MesnaSubjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically or cytologically confirmed Multiple Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that has not been previously treated.
- Bone marrow plasmacytosis with > or = 10% plasma cells, or sheets of plasma cells or a biopsy-proven plasmacytoma.
- Measurable levels of monoclonal protein (M protein): 1 g/dL Immunoglobulin G (IgG) or .5 g/dL Immunoglobulin A (IgA) on serum protein electrophoresis or > 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis.
- Age > or = 18 years.
- Life expectancy of greater than 12 months.
Key exclusion criteria (17 listed)
- Have had chemotherapy or radiotherapy for multiple myeloma within 4 weeks of baseline.
- Receiving any other investigational agents or therapy within 28 days of baseline.
- Brain metastases.
- Subjects who are pregnant or breast feeding.
- History of previous deep vein thrombosis or pulmonary embolism must be on anticoagulation therapy with low molecular weight heparin or warfarin at therapeutic dosages (e.g. International Normalized Ratio (INR) 2-3).
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 |
|---|---|---|
| Autologous peripheral blood stem cell transplantSubjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0. | Procedure or surgery | Arm A |
| LenalidomideAlso: CC-5013, RevlimidAdministered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle. | Drug | Arm A, Arm B |
| DexamethasoneAlso: Decadron, Hexadrol, Dexameth, DexoneAdministered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle. | Drug | Arm A, Arm B |
| Stem cell collectionAlso: Stem Cell MobilizationPeripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3. | Procedure or surgery | Arm A, Arm B |
| MelphalanAlso: EvomelaSubjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2. | Drug | Arm A |
| G-CSFAlso: Granulocyte-colony stimulating factor (CSF), FilgrastimSubjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover. | Drug | Arm A |
| CyclophosphamideAlso: CytophosphaneSubjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously. | Drug | Arm A, Arm B |
| MesnaAlso: MesnexMesna will be provided with the cyclophosphamide. | Drug | Arm A, Arm B |
Primary outcome
Complete Response Rate
Time frame: 3 years
The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).
4 secondary outcomes
Overall Survival Rate (OS)
Time frame: 4 years
Overall Survival Rate (OS)
Time frame: 2 years
Progression Free Survival (PFS)
Time frame: 4 years
Progression Free Survival (PFS)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be coded and shared with the University of Pittsburgh at the end of the trial.
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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.
Suzanne Lentzsch, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Autologous peripheral blood stem cell transplant, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Columbia University 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 22 inclusion and 17 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 5 Feb 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 15 Oct 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?
Complete Response Rate (time frame: 3 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 5 Feb 2020.