Combination Chemotherapy With or Without High Dose Cyclophosphamide and Recombinant Interferon Alfa-2b in Treating Patients With Previously Untreated Stage I-III Multiple Myeloma
The Treatment of Multiple Myeloma Utilizing VBMCP Chemotherapy Alternating With High-Dose Cyclophosphamide and Alpha2b-Interferon Versus VBMCP: A Phase III Study for Previously Untreated Multiple Myeloma
4 other identifiers
interventional
312
1 country
1
Brief Summary
This randomized phase III clinical trial studies combination chemotherapy with high dose cyclophosphamide and recombinant interferon alfa-2b to see how well it works compared to combination chemotherapy alone in treating patients with previously untreated stage I-III multiple myeloma. Drugs used in chemotherapy, such as vincristine sulfate, carmustine, melphalan, cyclophosphamide, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Recombinant interferon alfa-2b may interfere with the growth of cancer cells. It is not yet know whether giving combination chemotherapy with or without alternating high-dose cyclophosphamide and recombinant interferon alfa-2b is more effective in treating multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedMay 31, 2013
May 1, 2013
11.5 years
November 1, 1999
May 30, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Median survival
Detected using a one-sided log rank test at the .05 significance level.
Up to 1 year
Objective response, evaluated using the following ECOG Myeloma Response Criteria
Compared between treatment groups using a two-sided Fisher Exact Test at the .05 significance level. Response evaluation will be based on determination of reduction in serum and/or urine M-protein (monoclonal or myeloma protein) and on improvement in measurable soft tissue plasmacytomas when present.
Up to 1 year
Study Arms (2)
ARM A (VBMCP)
ACTIVE COMPARATORINDUCTION PHASE: Patients receive VBMCP comprising vincristine sulfate IV on day 1, carmustine IV on day 1, melphalan PO on days 1-4, cyclophosphamide IV on day 1, and prednisone PO on days 1-7. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients receive VBMCP as in the induction phase. Courses repeat every 35 days in the absence of disease progression or unacceptable toxicity.
Arm B (VBMCP, high dose cyclophosphamide, r alpha 2b IFN)
EXPERIMENTALINDUCTION PHASE: Patients receive VBMCP comprising vincristine sulfate IV on day 1, carmustine IV on day 1, melphalan PO on days 1-4, cyclophosphamide IV on day 1, and prednisone PO on days 1-7. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients receive vincristine sulfate, carmustine, and melphalan as in the induction phase, high-dose cyclophosphamide IV on days 1-4 and prednisone PO on days 1-4 during courses 3 and 5. Patients receive VBMCP as in the induction phase during even numbered courses. Patients receive recombinant interferon alfa-2b SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, and 22 during odd courses beginning course 7. Treatment repeats every 35 days for courses 3-5, every 21 days for even courses beginning course 6, and every 22 days for odd courses beginning course 7 in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Given PO
Given IV
Given PO
Given SC
Correlative studies
Eligibility Criteria
You may qualify if:
- Patients must have a diagnosis of multiple myeloma confirmed by the presence of:
- Bone marrow plasmacytosis with \>= 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytoma
- In addition, at least 1 of the following ancillary criteria must be documented:
- M-protein in the serum
- M-protein in the urine
- Radiographic evidence of osteolytic lesions (generalized osteoporosis qualifies only if the bone marrow aspirate contains \>= 20% plasma cells)
- Patients must have measurable disease; the following will constitute measurable disease; tests used to document measurable disease must be done within two weeks prior to registration; a bone marrow biopsy performed =\< 6 weeks prior to registration is acceptable; Note: If present, all of these parameters must be followed for response
- Serum M-protein \>= 1.0 g/dL by serum protein electrophoresis
- Urine M-protein (light chain) excretion \> 200 mg/24 hours by urine protein electrophoresis
- Measurable plasmacytoma(s) of soft tissue (must be biopsy proven)
- Bone marrow plasmacytosis \>= 20%
- Patients must not have been previously treated with chemotherapy; prior treatment of hypercalcemia with corticosteroids, bisphosphonates, or other agents does not disqualify the patient
- Patients refuses entry or is ineligible for S9321; Note: S9321, "Standard Dose Versus Myeloablative Therapy for Previously Untreated Symptomatic Multiple Myeloma" has priority over E5A93; patients with previously untreated multiple myeloma should be entered on S9321; patients who are ineligible for or decline entry to S9321 should be entered on E5A93 and E3A93 if eligible
- Patients treated with local radiotherapy to \> 15% of the bone marrow area are ineligible; patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed; if, in the physician's opinion, the delay in systemic therapy would itself pose undue risk, the patient may be entered and receive concurrent radiotherapy; in this situation, for the first VBMCP cycle, Melphalan, BCNU and Cyclophosphamide should be given at 75% of the dose
- Patients with Stages I, II, or III disease according to a modification of the clinical staging system by Durie and Salmon are eligible; staging should be based on values obtained at the time of diagnosis unless patient has had a more abnormal value prior to supportive treatment, transfusion, etc.; include only values obtained prior to initiation of protocol treatment
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Kyle
Eastern Cooperative Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
July 1, 1994
Primary Completion
January 1, 2006
Last Updated
May 31, 2013
Record last verified: 2013-05