Multiple Myeloma and Plasma Cell NeoplasmPhase 3NCT00002653
Combination Chemotherapy With or Without Cyclophosphamide and Prednisone in Treating Older Patients With Multiple Myeloma
A Phase 3 study testing carmustine, cyclophosphamide and doxorubicin hydrochloride in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Medical Research Council at 1 site in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating older patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 65 to 74 years
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- carmustine, cyclophosphamide and doxorubicin hydrochloride
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 1993to not given
- Phase
- Phase 3
- 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 65 to 74 years
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma, defined by at least 2 of the following conditions:
- Neoplastic cell infiltrate and/or microplasmacytomas by bone marrow sections or smears
- Plasma cell infiltrates greater than 20% of marrow nucleated cells or, if less than 20%, objective evidence of monoclonality of the plasma cells required
- Paraprotein in blood or urine
- Definite lytic bone lesions (not osteoporosis)
- Nonsecretory disease allowed in the presence of 1 of the following conditions:
- Microplasmacytomas
- Monoclonal plasmacytosis with immunoglobulin light-chain expression in cytoplasm
- No equivocal myelomatosis, defined by the following criteria:
- Minimal or no symptoms attributable to myelomatosis
- Pretransfusion hemoglobin greater than 10 g/dL
- Post-hydration creatinine less than 1.47 mg/dL
- No osteolytic lesions except minimal lesions that do not threaten pathological fracture and are not associated with pain
- Plasma cells less than 30% of marrow nucleated cells and marrow showing normal hematopoietic activity
- Serum beta-2 microglobulin less than 4 mg/L
- Less than 1 g of free light-chain excretion per 1 g of creatinine
- No objective factors indicating progressive myelomatosis
PATIENT CHARACTERISTICS:
Age:
- 65 to 74
- If under 65, higher priority is given to protocol MRC-LEUK-MYEL-VII unless entry into this study would be more appropriate
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
- Neutrophil count at least 1,300/mm^3
- Platelet count at least 75,000/mm^3
Hepatic:
- Not specified
Renal:
- See Disease Characteristics
Other:
- Ability to tolerate fluid intake of at least 3 L/day beginning at least 2 days before study entry
- Afebrile and free of infection
- No contraindication to therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Prior or concurrent prednisolone at 30 mg/m2/day or less (or equivalent doses of other corticosteroids) for relief of fluid-unresponsive hypercalcemia allowed
Radiotherapy:
- Prior or concurrent minimal local radiotherapy to relieve persistent bone pain or cord compression allowed
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
MRC Myelomatosis Trials Office
Birmingham, England, B15 2SZ
About this study
Official title: VIIITH MYELOMATOSIS TRIAL: A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating older patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without cyclophosphamide and prednisone in treating older patients with multiple myeloma.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of doxorubicin, carmustine, cyclophosphamide, and melphalan (ABCM) with or without oral cyclophosphamide and prednisone as induction for the first plateau phase in elderly patients with previously untreated multiple myeloma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center.
Patients receive doxorubicin IV followed immediately by carmustine IV over 1-2 hours on day 1 and oral melphalan (L-PAM) and oral cyclophosphamide (CTX) on days 22-25 (ABCM). Treatment continues every 6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients whose blood counts recover within 6 weeks after beginning L-PAM and CTX during course 3 are randomized to 1 of 2 treatment arms. Patients whose blood counts fail to recover within 6 weeks after beginning L-PAM and CTX during course 3 are assigned to arm II.
- Arm I: Patients continue ABCM for a maximum of 12 courses in the absence of a plateau phase after completion of at least 4 courses, disease progression, or unacceptable toxicity.
- Arm II: Patients receive oral cyclophosphamide once weekly and oral prednisone every other day. Treatment continues every 6 weeks in the absence of a plateau phase after completion of 3 courses of ABCM plus a minimum of 8 weeks on arm II or less than 3 courses of ABCM plus 6 months on arm II, disease progression, or unacceptable toxicity.
Patients on both arms with bone pain or failure to respond to chemotherapy may undergo minimal radiotherapy. Patients achieving plateau phase may enter the MRC trial of interferon alfa-2b.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within approximately 5 years.
- Being tested
- carmustine, cyclophosphamide, doxorubicin hydrochloride, melphalan, prednisone
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carmustineDrug
cyclophosphamideDrug
melphalanDrug
prednisoneDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2003 (estimated)
- Study startSep 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- M. T. Drayson, MD, Study chair, MRC Myelomatosis Trials Office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002653
- Sponsor's protocol ID
- CDR0000064187
- Other IDs
- MRC-LEUK-MYEL-VIII, EU-94031
- Status last verified
- Oct 2002
- First submitted
- 1 Nov 1999
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIIITH MYELOMATOSIS TRIAL: A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE
- ClinicalTrials.gov ID
- NCT00002653
- Acronym / sponsor ID
- CDR0000064187
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Sep 1993
- First posted
- 10 Apr 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating older patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without cyclophosphamide and prednisone in treating older patients with multiple myeloma.
Detailed description
OBJECTIVES:
- Compare the efficacy of doxorubicin, carmustine, cyclophosphamide, and melphalan (ABCM) with or without oral cyclophosphamide and prednisone as induction for the first plateau phase in elderly patients with previously untreated multiple myeloma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center.
Patients receive doxorubicin IV followed immediately by carmustine IV over 1-2 hours on day 1 and oral melphalan (L-PAM) and oral cyclophosphamide (CTX) on days 22-25 (ABCM). Treatment continues every 6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients whose blood counts recover within 6 weeks after beginning L-PAM and CTX during course 3 are randomized to 1 of 2 treatment arms. Patients whose blood counts fail to recover within 6 weeks after beginning L-PAM and CTX during course 3 are assigned to arm II.
- Arm I: Patients continue ABCM for a maximum of 12 courses in the absence of a plateau phase after completion of at least 4 courses, disease progression, or unacceptable toxicity.
- Arm II: Patients receive oral cyclophosphamide once weekly and oral prednisone every other day. Treatment continues every 6 weeks in the absence of a plateau phase after completion of 3 courses of ABCM plus a minimum of 8 weeks on arm II or less than 3 courses of ABCM plus 6 months on arm II, disease progression, or unacceptable toxicity.
Patients on both arms with bone pain or failure to respond to chemotherapy may undergo minimal radiotherapy. Patients achieving plateau phase may enter the MRC trial of interferon alfa-2b.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within approximately 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 65 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| carmustine | Drug | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| melphalan | Drug | – |
| prednisone | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
Related trials for Multiple Myeloma and Plasma Cell Neoplasm
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
M. T. Drayson, MD study chair
MRC Myelomatosis Trials Office
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carmustine, cyclophosphamide and doxorubicin hydrochloride in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Medical Research Council at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 19 Dec 2013. 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 Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 19 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.