Multiple MyelomaPhase 2MRDNCT00679367
Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
A Phase 2 study testing dexamethasone, lenalidomide and melphalan in people with Multiple Myeloma, run by Boston Medical Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. 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?
- dexamethasone, lenalidomide and melphalan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2015
- 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
- DISEASE CHARACTERISTICS:
- Diagnosis of primary systemic amyloidosis
- PATIENT CHARACTERISTICS:
- Not pregnant
- Negative pregnancy test
- Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day, therapeutic warfarin, or low molecular weight heparin)
Show all 11Show fewer
- PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- Permanent or stable side effects/changes allowed
- Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed
- More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or radiotherapy
Who cannot join
- No secondary or familial amyloidosis
- No multiple myeloma (≥ 30% plasma cells in bone marrow biopsy or lytic bone lesions)
- No prior cumulative doses of oral melphalan > 200 mg
- No more than one prior course of high-dose melphalan with stem cell transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Cancer Research Center
Boston, Massachusetts, 02118
About this study
Official title: A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis.
PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.
Read the detailed description
OBJECTIVES:
Primary
- To determine the tolerability and safety of melphalan, lenalidomide, and dexamethasone, in terms of toxicity, in patients with primary systemic amyloidosis.
- To determine the hematologic response rate in patients treated with this regimen.
Secondary
- To assess organ response in patients treated with this regimen.
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21, oral melphalan once daily on days 1-4, and oral dexamethasone once on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months until disease progression and then annually thereafter.
- Conditions
- Multiple Myeloma
- Being tested
- dexamethasone, lenalidomide, melphalan
- Keywords
- primary systemic amyloidosis
- Medical subject headings
- Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Also called Decadron
40 mg once weekly
lenalidomideDrug
Also called revlimid, cc-5013
10 mg/day D1-21
melphalanDrug
Also called alkeran
5 mg/m2 D1-4
| Study group | Role | What they receive |
|---|---|---|
| Melphalan Revlimid and Dexamethasone | Experimental | Melphalan Lenalidomide Dexamethasone Receives: Drug: dexamethasone; Drug: lenalidomide; Drug: melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hematologic Response
Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.
Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more.
Measured: one year
Secondary outcomes (2)
Number of Organs Improved or Stable Based on Description Below:
Renal response - > 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency.
Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline.
Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness > 11 mm or a decrease in New York Heart Association heart failure class.
Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus.
Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid.
Peripheral nervous system response - resolution of clinical signs of peripheral neuropathy.
Measured: one year
Number of Participants Removed From Study Due to Toxicities
Number of study participants removed from study treatment due to toxicities
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2015
- Study completionMay 2015
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 (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaishali Sanchorawala, Boston Medical Center
- Investigators
- Vaishali Sanchorawala, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679367
- Sponsor's protocol ID
- CDR0000595759
- Other IDs
- RV-AMYL-PI-0219, BUMC-H-26320
- Acronym
- MRD
- Status last verified
- Dec 2016
- First submitted
- 14 May 2008
- Last updated
- 20 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sanchorawala V, Patel JM, Sloan JM, Shelton AC, Zeldis JB, Seldin DC. Melphalan, lenalidomide and dexamethasone for the treatment of immunoglobulin light chain amyloidosis: results of a phase II trial. Haematologica. 2013 May;98(5):789-92. doi: 10.3324/haematol.2012.075192. Epub 2012 Nov 9.
PubMed 23144200
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis
- ClinicalTrials.gov ID
- NCT00679367
- Acronym / sponsor ID
- MRD / CDR0000595759
- Conditions
- Multiple Myeloma
- Keywords
- primary systemic amyloidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 May 2008 (estimated)
- Results
- Posted 20 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis.
PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.
Detailed description
OBJECTIVES:
Primary
- To determine the tolerability and safety of melphalan, lenalidomide, and dexamethasone, in terms of toxicity, in patients with primary systemic amyloidosis.
- To determine the hematologic response rate in patients treated with this regimen.
Secondary
- To assess organ response in patients treated with this regimen.
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21, oral melphalan once daily on days 1-4, and oral dexamethasone once on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months until disease progression and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melphalan Revlimid and Dexamethasone | Experimental | Drug: dexamethasone, Drug: lenalidomide, Drug: melphalanMelphalan Lenalidomide Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of primary systemic amyloidosis
- Not pregnant
- Negative pregnancy test
- Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day, therapeutic warfarin, or low molecular weight heparin)
- Recovered from prior therapy
Key exclusion criteria (4 listed)
- No secondary or familial amyloidosis
- No multiple myeloma (≥ 30% plasma cells in bone marrow biopsy or lytic bone lesions)
- No prior cumulative doses of oral melphalan > 200 mg
- No more than one prior course of high-dose melphalan with stem cell transplant
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 |
|---|---|---|
| dexamethasoneAlso: Decadron40 mg once weekly | Drug | Melphalan Revlimid and Dexamethasone |
| lenalidomideAlso: revlimid, cc-501310 mg/day D1-21 | Drug | Melphalan Revlimid and Dexamethasone |
| melphalanAlso: alkeran5 mg/m2 D1-4 | Drug | Melphalan Revlimid and Dexamethasone |
Primary outcome
Number of Participants With Hematologic Response
Time frame: one year
Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more.
2 secondary outcomes
Number of Organs Improved or Stable Based on Description Below:
Time frame: one year
Number of Participants Removed From Study Due to Toxicities
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23144200Sanchorawala V, Patel JM, Sloan JM, Shelton AC, Zeldis JB, Seldin DC. Melphalan, lenalidomide and dexamethasone for the treatment of immunoglobulin light chain amyloidosis: results of a phase II trial. Haematologica. 2013 May;98(5):789-92. doi: 10.3324/haematol.2012.075192. Epub 2012 Nov 9.
- 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.
Vaishali Sanchorawala, MD principal investigator
Boston 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 2 study testing dexamethasone, lenalidomide and melphalan in people with Multiple Myeloma, run by Boston 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 11 inclusion and 4 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 20 Feb 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 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 20 Feb 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?
Number of Participants With Hematologic Response (time frame: one year). 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 NCT00679367, which also lists 1 linked publication.
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 20 Feb 2017.