Multiple MyelomaPhase 2NCT00091260
CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
A Phase 2 study testing dexamethasone and lenalidomide in people with Multiple Myeloma, run by Vaishali Sanchorawala at 1 site in United States.
Trial summary
RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis. PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis. 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 and lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to 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:
- Histologically confirmed primary systemic (AL) amyloidosis
- Tissue amyloid deposits or positive fat aspirate
- Meets 1 of the following criteria for AL type disease:
- Serum or urine monoclonal protein by immunofixation electrophoresis
- Plasmacytosis of bone marrow by monoclonal staining for kappa- or lambda-light chain isotype
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- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- SWOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- White blood count> 3,000/mm^3
- Hemoglobin > 8 g/dL
- Platelet count > 100,000/mm^3
- Absolute neutrophil count > 1,000/mm^3
- Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Prior thalidomide for AL amyloidosis allowed
- Chemotherapy
- More than 4 weeks since prior cytotoxic chemotherapy
- Endocrine therapy
- Prior steroids for AL amyloidosis allowed
- Radiotherapy
- More than 4 weeks since prior radiotherapy
- Surgery
- Prior surgery allowed
- Other
- Recovered from all prior therapy
Who cannot join
- No secondary or familial amyloidosis
- No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR lytic bone lesions
- No prior CC-5013
- Renal
- No dialysis
- Cardiovascular
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- No symptomatic cardiac arrhythmia
- No oxygen-dependent restrictive cardiomyopathy
- Other
- No untreated or uncontrolled infection
- No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix or breast
- No other serious medical illness that would preclude study participation
- No history of hypersensitivity reaction to thalidomide
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118
About this study
Official title: A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis
RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis.
PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis.
Read the detailed description
OBJECTIVES:
Primary
- Determine the tolerability of CC-5013 in patients with primary systemic (AL) amyloidosis.
- Determine the objective hematologic response rate in patients treated with this drug.
- Determine amyloid organ disease response in patients treated with this drug.
Secondary
- Determine hematologic and amyloid organ disease response in patients who do not achieve a response to CC-5013 alone and are subsequently treated with CC-5013 and dexamethasone.
- Determine the toxicity of CC-5013 in combination with dexamethasone in these patients.
OUTLINE: Patients receive oral CC-5013 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response continue to receive CC-5013 as before and also receive oral dexamethasone twice daily on days 1-4, 9-12, and 17-20 of every other 28-day course for up to 6 courses of combination therapy. Patients who maintain a hematologic response after 6 courses of combination therapy may receive CC-5013 alone in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response after the initiation of dexamethasone are removed from the study.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-12.5 months.
- Conditions
- Multiple Myeloma
- Being tested
- dexamethasone, lenalidomide
- 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 dexamethasone acetate
dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
lenalidomideDrug
Also called revlimid; CC-5013
15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| revlimid | Experimental | lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle. Receives: Drug: dexamethasone; Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Removed From Study Treatment Due to Toxicities
Measured: 1 year
Number of Patients With Hematologic Response With Single-agent CC-5013
Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.
Partial response= 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 in 24 hour urine.
For patients with an elevated serum free light chain assay, a reduction of 50% or more.
Measured: 3 months
Secondary outcomes (1)
Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2004 (estimated)
- Study startJan 2004
- Primary completionJul 2012
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaishali Sanchorawala
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor-investigator, Vaishali Sanchorawala, Boston Medical Center
- Investigators
- David C. Seldin, MD, PhD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091260
- Sponsor's protocol ID
- CDR0000385687
- Other IDs
- BUMC-H-23235, CELGENE-RV-AMYL-PI-003
- Status last verified
- Dec 2016
- First submitted
- 7 Sep 2004
- Last updated
- 20 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lichtman EI, Seldin DC, Shelton A, Sanchorawala V. Single agent lenalidomide three times a week induces hematologic responses in AL amyloidosis patients on dialysis. Am J Hematol. 2014 Jul;89(7):706-8. doi: 10.1002/ajh.23722. Epub 2014 Apr 10.
PubMed 24668858
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 the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis
- ClinicalTrials.gov ID
- NCT00091260
- Acronym / sponsor ID
- CDR0000385687
- Conditions
- Multiple Myeloma
- Keywords
- primary systemic amyloidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Vaishali SanchorawalaUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jan 2004
- Primary completion
- Jul 2012 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Sep 2004 (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 such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis.
PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis.
Detailed description
OBJECTIVES:
Primary
- Determine the tolerability of CC-5013 in patients with primary systemic (AL) amyloidosis.
- Determine the objective hematologic response rate in patients treated with this drug.
- Determine amyloid organ disease response in patients treated with this drug.
Secondary
- Determine hematologic and amyloid organ disease response in patients who do not achieve a response to CC-5013 alone and are subsequently treated with CC-5013 and dexamethasone.
- Determine the toxicity of CC-5013 in combination with dexamethasone in these patients.
OUTLINE: Patients receive oral CC-5013 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response continue to receive CC-5013 as before and also receive oral dexamethasone twice daily on days 1-4, 9-12, and 17-20 of every other 28-day course for up to 6 courses of combination therapy. Patients who maintain a hematologic response after 6 courses of combination therapy may receive CC-5013 alone in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response after the initiation of dexamethasone are removed from the study.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-12.5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| revlimid | Experimental | Drug: dexamethasone, Drug: lenalidomidelenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Histologically confirmed primary systemic (AL) amyloidosis
- Meets 1 of the following criteria for AL type disease:
- Age
- 18 and over
- Performance status
Key exclusion criteria (17 listed)
- No secondary or familial amyloidosis
- No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR lytic bone lesions
- No prior CC-5013
- Renal
- No dialysis
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: dexamethasone acetatedexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle. | Drug | revlimid |
| lenalidomideAlso: revlimid; CC-501315 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone | Drug | revlimid |
Primary outcome
Number of Patients Removed From Study Treatment Due to Toxicities
Time frame: 1 year
Number of Patients With Hematologic Response With Single-agent CC-5013
Time frame: 3 months
Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial response= 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 in 24 hour urine. For patients with an elevated serum free light chain assay, a reduction of 50% or more.
1 secondary outcome
Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response
Time frame: 1 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 24668858Lichtman EI, Seldin DC, Shelton A, Sanchorawala V. Single agent lenalidomide three times a week induces hematologic responses in AL amyloidosis patients on dialysis. Am J Hematol. 2014 Jul;89(7):706-8. doi: 10.1002/ajh.23722. Epub 2014 Apr 10.
- 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.
David C. Seldin, MD, PhD 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 and lenalidomide in people with Multiple Myeloma, run by Vaishali Sanchorawala 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 34 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 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 Patients Removed From Study Treatment Due to Toxicities (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT00091260, 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.