Multiple MyelomaPhase 2NCT00002849
S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis
A Phase 2 study testing recombinant interferon alfa and dexamethasone in people with Multiple Myeloma, run by SWOG Cancer Research Network at 40 sites in United States.
Trial summary
RATIONALE: Chemotherapy plus interferon alfa may be effective for primary systemic amyloidosis. PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus interferon alfa in treating patients who have 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?
- recombinant interferon alfa and dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 40 sitesUnited States
- Study dates
- Nov 1996to Jul 2000
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Histologically diagnosed primary systemic amyloidosis based on the following:
- Deposition of fibrillary protein with Congo red positive stain or characteristic electron microscopic appearance
- Monoclonal light chain protein (Bence-Jones protein) in serum or urine or immunohistochemical studies
- Evidence of tissue involvement other than carpal tunnel syndrome
- Diagnostic histologic material available for central pathology review
- Confirmation of tissue diagnosis at all sites of organ dysfunction encouraged
- No senile, secondary, localized, dialysis-related, or familial amyloidosis
- No known therapy-related myelodysplasia
PATIENT CHARACTERISTICS:
Age:
- Adult
Performance status:
- SWOG 0-4
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No NYHA class IV status
Other:
- No uncontrolled diabetes
- No active peptic ulcer disease
- No medical condition that precludes high-dose steroids
- No second malignancy within 5 years except:
- Adequately treated nonmelanomatous skin cancer
- In situ cervical cancer
- Adequately treated stage I/II cancer in complete remission
- Not pregnant or nursing
- Effective contraception required of fertile patients
- Blood/body fluid analyses within 14 days prior to registration
- Imaging/exams for tumor measurement within 28 days prior to registration
- Other screening exams within 42 days prior to registration
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior interferon alfa
Chemotherapy
- Prior melphalan allowed, but recovered from effects
- At least 4 weeks since cytotoxic therapy and recovered
Endocrine therapy
- Prior prednisone allowed, but recovered from effects
- At least 4 weeks since prior glucocorticoids
- No prior dexamethasone
- No planned or concurrent dexamethasone or other therapy for primary systemic amyloidosis
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Vermont Cancer Center
Burlington, Vermont, 05401-3498
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
CCOP - North Shore University Hospital
Manhasset, New York, 11030
North Shore University Hospital
Manhasset, New York, 11030
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Weill Medical College of Cornell University
New York, New York, 10021
Mount Sinai Medical Center, NY
New York, New York, 10029
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
Barnes-Jewish Hospital
St Louis, Missouri, 63110
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
About this study
Official title: Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis
RATIONALE: Chemotherapy plus interferon alfa may be effective for primary systemic amyloidosis.
PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus interferon alfa in treating patients who have primary systemic amyloidosis.
Read the detailed description
OBJECTIVES:
- Evaluate M protein and organ dysfunction responses and overall and progression-free survival in patients with primary systemic amyloidosis treated with dexamethasone/interferon alfa.
- Identify prognostic factors that may relate to response and overall survival in these patients.
- Evaluate the qualitative and quantitative toxic effects of this regimen.
OUTLINE: Patients are stratified by prior amyloidosis treatment (yes vs no).
All patients receive induction therapy with oral dexamethasone on days 1-4, 9-12, and 17-20 every 35 days for a total of 3 courses.
Maintenance therapy begins within 5-8 weeks (within 10 weeks if patients undergo stem cell harvest) of initiation of the third course of induction, as follows: oral dexamethasone for 4 days every 4 weeks; and subcutaneous interferon alfa 3 times per week. Patients who achieved less than a 50% reduction in serum M protein or urinary Bence-Jones protein and who experienced less than grade 3 toxicity during induction receive 3 additional courses of pulse dexamethasone concurrently with entry to maintenance therapy and the initiation of interferon alfa.
Combination therapy is continued until 2 years from entry; thereafter, interferon is administered alone for at least 3 years, toxicity permitting. Patients with stable disease after 5 years of therapy may discontinue interferon alfa at the discretion of the treating physician.
Patients are followed every 6 months for 2 years and yearly thereafter.
PROJECTED ACCRUAL: A total of 100 patients (50 with prior melphalan/prednisone or iododoxorubicin treatment and 50 without) will be entered over 3 years.
- Conditions
- Multiple Myeloma
- Being tested
- recombinant interferon alfa, dexamethasone
- 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.
recombinant interferon alfaBiological
Also called alpha interferon
first 2 years
dexamethasoneDrug
Also called decadron
40 mg*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles*
| Study group | Role | What they receive |
|---|---|---|
| induction and maintenance | Experimental | dexamethasone induction followed by alpha interferon maintenance Receives: Biological: recombinant interferon alfa; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
response
50% or more reduction in quantitative immunoglobulin, or if the patient has light-chain disease only, a 50% or more reduction in the urine M-component (Bence-Jones protein).
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 1996
- Primary completionDec 1998
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Cancer and Leukemia Group B
- Responsible party
- Sponsor
- Investigators
- Laura F. Hutchins, MD, Study chair, University of ArkansasRichard A. Larson, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002849
- Sponsor's protocol ID
- S9628
- Other IDs
- S9628, CLB-9790, CLB-S9628, U10CA032102
- Status last verified
- Mar 2015
- First submitted
- 1 Nov 1999
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dhodapkar MV, Hussein MA, Rasmussen E, Solomon A, Larson RA, Crowley JJ, Barlogie B; United States Intergroup Trial Southwest Oncology Group. Clinical efficacy of high-dose dexamethasone with maintenance dexamethasone/alpha interferon in patients with primary systemic amyloidosis: results of United States Intergroup Trial Southwest Oncology Group (SWOG) S9628. Blood. 2004 Dec 1;104(12):3520-6. doi: 10.1182/blood-2004-05-1924. Epub 2004 Aug 12.
PubMed 15308571Dhodapkar M, Jacobson J, Hussein M, et al.: High dose dexamethasone (Dex) with maintenance Dex / alpha interferon leads to improved survival in patients with primary systemic amyloidosis: results of US Intergroup Trial Southwest Oncology Group (SWOG) S9628. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2278, 2003.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis
- ClinicalTrials.gov ID
- NCT00002849
- Acronym / sponsor ID
- S9628
- Conditions
- Multiple Myeloma
- Keywords
- primary systemic amyloidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI), Cancer and Leukemia Group B
- Study start
- Nov 1996
- Primary completion
- Dec 1998 (actual)
- Study completion
- Jul 2000 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemotherapy plus interferon alfa may be effective for primary systemic amyloidosis.
PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus interferon alfa in treating patients who have primary systemic amyloidosis.
Detailed description
OBJECTIVES:
- Evaluate M protein and organ dysfunction responses and overall and progression-free survival in patients with primary systemic amyloidosis treated with dexamethasone/interferon alfa.
- Identify prognostic factors that may relate to response and overall survival in these patients.
- Evaluate the qualitative and quantitative toxic effects of this regimen.
OUTLINE: Patients are stratified by prior amyloidosis treatment (yes vs no).
All patients receive induction therapy with oral dexamethasone on days 1-4, 9-12, and 17-20 every 35 days for a total of 3 courses.
Maintenance therapy begins within 5-8 weeks (within 10 weeks if patients undergo stem cell harvest) of initiation of the third course of induction, as follows: oral dexamethasone for 4 days every 4 weeks; and subcutaneous interferon alfa 3 times per week. Patients who achieved less than a 50% reduction in serum M protein or urinary Bence-Jones protein and who experienced less than grade 3 toxicity during induction receive 3 additional courses of pulse dexamethasone concurrently with entry to maintenance therapy and the initiation of interferon alfa.
Combination therapy is continued until 2 years from entry; thereafter, interferon is administered alone for at least 3 years, toxicity permitting. Patients with stable disease after 5 years of therapy may discontinue interferon alfa at the discretion of the treating physician.
Patients are followed every 6 months for 2 years and yearly thereafter.
PROJECTED ACCRUAL: A total of 100 patients (50 with prior melphalan/prednisone or iododoxorubicin treatment and 50 without) will be entered over 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| induction and maintenance | Experimental | Biological: recombinant interferon alfa, Drug: dexamethasonedexamethasone induction followed by alpha interferon maintenance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| recombinant interferon alfaAlso: alpha interferonfirst 2 years | Biological | induction and maintenance |
| dexamethasoneAlso: decadron40 mg*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles* | Drug | induction and maintenance |
Primary outcome
response
Time frame: 10 months
50% or more reduction in quantitative immunoglobulin, or if the patient has light-chain disease only, a 50% or more reduction in the urine M-component (Bence-Jones protein).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Results publication: PubMed 15308571Dhodapkar MV, Hussein MA, Rasmussen E, Solomon A, Larson RA, Crowley JJ, Barlogie B; United States Intergroup Trial Southwest Oncology Group. Clinical efficacy of high-dose dexamethasone with maintenance dexamethasone/alpha interferon in patients with primary systemic amyloidosis: results of United States Intergroup Trial Southwest Oncology Group (SWOG) S9628. Blood. 2004 Dec 1;104(12):3520-6. doi: 10.1182/blood-2004-05-1924. Epub 2004 Aug 12.
- Results publicationDhodapkar M, Jacobson J, Hussein M, et al.: High dose dexamethasone (Dex) with maintenance Dex / alpha interferon leads to improved survival in patients with primary systemic amyloidosis: results of US Intergroup Trial Southwest Oncology Group (SWOG) S9628. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2278, 2003.
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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.
Laura F. Hutchins, MD study chair
University of Arkansas
Richard A. Larson, MD study chair
University of Chicago
40 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 recombinant interferon alfa and dexamethasone in people with Multiple Myeloma, run by SWOG Cancer Research Network at 40 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?
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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
response (time frame: 10 months). 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 NCT00002849, 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 6 Mar 2015.