LeukemiaNCT00890552
A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
A study testing Lenalidomide, Melphalan and Dexamethasone in people with Leukemia and Amyloidosis, run by Stanford University at 1 site in United States.
Trial summary
This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Amyloidosis
- What is being tested?
- Lenalidomide, Melphalan and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Oct 2012
- 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
- Newly diagnosed or relapsed AL amyloidosis
- Biopsy-proven amyloidosis with evidence of an underlying plasma cell dyscrasia
- abnormal clonal dominance of plasma cells in the bone marrow
- detection of a monoclonal gammopathy by immunofixation electrophoresis of serum and/or urine
- an abnormal serum free light chain or ratio, or AL fibrils seen on biopsy)
- Measurable disease defined by an abnormal serum-free light chain or monoclonal protein by immunofixation
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- proteinuria ≥ 0.5 g/day, cardiac involvement with interventricular septal thickness ≥ 15 mm
- hepatomegaly in the absence of congestive heart failure with elevated alkaline phosphatase
- Age ≥ 18 years at the time of signing the informed consent form.
- All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study
- ECOG performance status of ≤ 3 at study entry
- Laboratory test results:
- Absolute neutrophil count ≥ 1.0 x 10e9 / L
- Platelet count ≥ 75 x 10e9 / L
- Creatinine clearance ≥ 15 mL/ minute
- Total bilirubin ≤ 2-fold upper limits of normal
- Disease-free of prior malignancies (excluding multiple myeloma) for ≥ 3 years with exception of:
- currently treated basal cell
- squamous cell carcinoma of the skin
- carcinoma "in situ" of the cervix or breast.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test
- Females of childbearing potential must either:
- commit to continued abstinence from heterosexual intercourse
- acceptable methods of birth control and agree to ongoing pregnancy testing
- Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
- All study participants must be registered into the mandatory RevAssist program, and able to comply with its requirements
- Able to take aspirin (81 mg) daily • Understand and voluntarily sign an informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Any serious medical condition that would prevent the subject from signing the informed consent form
- Pregnant
- breast-feeding females
- Use of any other experimental drug or therapy within 28 days of baseline
- Known hypersensitivity to thalidomide
- Erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
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- Any prior use of lenalidomide
- Concurrent use of other anti-cancer agents or treatments
- Known positivity for human immunodeficiency virus HIV)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Cancer Institute
Stanford, California, 94305
About this study
This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles.
Read the detailed description
The study will evaluate the 3-drug combination of lenalidomide; melphalan; and dexamethasone (MDR) as the absence of disease progression or toxicity, patients will complete nine 28-day cycles of MDR therapy, with the option of continuing treatment with lenalidomide as single-agent. Patients received up to nine cycles of treatment, with the option to continue on lenalidomide as a single agent if they responded to treatment.
- Conditions
- Leukemia, Amyloidosis
- Being tested
- Lenalidomide, Melphalan, Dexamethasone
- Medical subject headings
- Leukemia, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid, L04AX04
Lenalidomide is a a derivative of thalidomide.
Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle.
MelphalanDrug
Also called Alkeran, Evomela, Sarcolysin, L-phenylalanine mustard (L-PAM)
Melphalan is a phenylalanine derivative of mechlorethamine.
Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle
DexamethasoneDrug
Also called Intensol, Decadron, Baycadron, Dexpak® Taperpak
Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication.
Orally-administered dexamethasone 40 mg orally once weekly of a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide+Melphalan+Dexamethasone | Experimental | Patients received lenalidomide 10 mg/day orally on days 1-21, melphalan 0.18 mg/kg orally on days 1-4, and dexamethasone 40 mg orally once weekly of a 28-day cycle (MDR treatment). Receives: Drug: Lenalidomide; Drug: Melphalan; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic Response Rate
At the end of each treatment cycle (4 weeks), hematologic response rate as assessed. Hematologic response was considered to be amyloid complete response (normal FLC ratio and negative serum and urine immunofixation); very good partial response (difference between involved and uninvolved FLCs [dFLC] < 40 mg/L); or partial response (dFLC decrease > 50%).
Measured: 8 weeks
Secondary outcomes (3)
Overall Survival (OS)
Participants alive 12 months after starting MDR treatment.
Measured: 12 months
Event-free Survival (EFS)
Assessed as the median value for EFS 12 months after starting MDR treatment
Measured: 12 months
Duration of Response
Assessed as the median value for the time from first partial response until progression; death; or last follow-up.
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2012
- Study completionOct 2012
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Stanford 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Principal investigator, Stanley L Schrier, Stanford University
- Investigators
- Stanley L Schrier, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890552
- Sponsor's protocol ID
- IRB-15213
- Other IDs
- RV-AMYL-PI-0375, SU-09192008-1300, HEM0010
- Status last verified
- Feb 2017
- First submitted
- 28 Apr 2009
- Last updated
- 22 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Palladini G, Dispenzieri A, Gertz MA, Kumar S, Wechalekar A, Hawkins PN, Schonland S, Hegenbart U, Comenzo R, Kastritis E, Dimopoulos MA, Jaccard A, Klersy C, Merlini G. New criteria for response to treatment in immunoglobulin light chain amyloidosis based on free light chain measurement and cardiac biomarkers: impact on survival outcomes. J Clin Oncol. 2012 Dec 20;30(36):4541-9. doi: 10.1200/JCO.2011.37.7614. Epub 2012 Oct 22.
PubMed 23091105Dinner S, Witteles W, Afghahi A, Witteles R, Arai S, Lafayette R, Schrier SL, Liedtke M. Lenalidomide, melphalan and dexamethasone in a population of patients with immunoglobulin light chain amyloidosis with high rates of advanced cardiac involvement. Haematologica. 2013 Oct;98(10):1593-9. doi: 10.3324/haematol.2013.084574. Epub 2013 May 28.
PubMed 23716538
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
- ClinicalTrials.gov ID
- NCT00890552
- Acronym / sponsor ID
- IRB-15213
- Conditions
- Leukemia, Amyloidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Apr 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Apr 2009 (estimated)
- Results
- Posted 22 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles.
Detailed description
The study will evaluate the 3-drug combination of lenalidomide; melphalan; and dexamethasone (MDR) as the absence of disease progression or toxicity, patients will complete nine 28-day cycles of MDR therapy, with the option of continuing treatment with lenalidomide as single-agent. Patients received up to nine cycles of treatment, with the option to continue on lenalidomide as a single agent if they responded to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide+Melphalan+Dexamethasone | Experimental | Drug: Lenalidomide, Drug: Melphalan, Drug: DexamethasonePatients received lenalidomide 10 mg/day orally on days 1-21, melphalan 0.18 mg/kg orally on days 1-4, and dexamethasone 40 mg orally once weekly of a 28-day cycle (MDR treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Newly diagnosed or relapsed AL amyloidosis
- Biopsy-proven amyloidosis with evidence of an underlying plasma cell dyscrasia
- Measurable disease defined by an abnormal serum-free light chain or monoclonal protein by immunofixation
- Age ≥ 18 years at the time of signing the informed consent form.
- All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study
Key exclusion criteria (9 listed)
- Any serious medical condition that would prevent the subject from signing the informed consent form
- Pregnant
- breast-feeding females
- Use of any other experimental drug or therapy within 28 days of baseline
- Known hypersensitivity to thalidomide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: Revlimid, L04AX04Lenalidomide is a a derivative of thalidomide. Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. | Drug | Lenalidomide+Melphalan+Dexamethasone |
| MelphalanAlso: Alkeran, Evomela, Sarcolysin, L-phenylalanine mustard (L-PAM)Melphalan is a phenylalanine derivative of mechlorethamine. Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle | Drug | Lenalidomide+Melphalan+Dexamethasone |
| DexamethasoneAlso: Intensol, Decadron, Baycadron, Dexpak® TaperpakDexamethasone is an anti-inflammatory and immunosuppressant steroid medication. Orally-administered dexamethasone 40 mg orally once weekly of a 28-day cycle | Drug | Lenalidomide+Melphalan+Dexamethasone |
Primary outcome
Hematologic Response Rate
Time frame: 8 weeks
At the end of each treatment cycle (4 weeks), hematologic response rate as assessed. Hematologic response was considered to be amyloid complete response (normal FLC ratio and negative serum and urine immunofixation); very good partial response (difference between involved and uninvolved FLCs [dFLC] < 40 mg/L); or partial response (dFLC decrease > 50%).
3 secondary outcomes
Overall Survival (OS)
Time frame: 12 months
Event-free Survival (EFS)
Time frame: 12 months
Duration of Response
Time frame: 32 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23091105Palladini G, Dispenzieri A, Gertz MA, Kumar S, Wechalekar A, Hawkins PN, Schonland S, Hegenbart U, Comenzo R, Kastritis E, Dimopoulos MA, Jaccard A, Klersy C, Merlini G. New criteria for response to treatment in immunoglobulin light chain amyloidosis based on free light chain measurement and cardiac biomarkers: impact on survival outcomes. J Clin Oncol. 2012 Dec 20;30(36):4541-9. doi: 10.1200/JCO.2011.37.7614. Epub 2012 Oct 22.
- Results publication: PubMed 23716538Dinner S, Witteles W, Afghahi A, Witteles R, Arai S, Lafayette R, Schrier SL, Liedtke M. Lenalidomide, melphalan and dexamethasone in a population of patients with immunoglobulin light chain amyloidosis with high rates of advanced cardiac involvement. Haematologica. 2013 Oct;98(10):1593-9. doi: 10.3324/haematol.2013.084574. Epub 2013 May 28.
- 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.
Stanley L Schrier, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenalidomide, Melphalan and Dexamethasone in people with Leukemia and Amyloidosis, run by Stanford 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 28 inclusion and 9 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 22 Mar 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2017). 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?
Hematologic Response Rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00890552, which also lists 2 linked publications.
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 22 Mar 2017.