Clinical trial · Interventional
Combination Chemotherapy With or Without Cyclophosphamide and Prednisone in Treating Older Patients With Multiple Myeloma
VIIITH MYELOMATOSIS TRIAL: A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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 specifiedReferences
Publications (0)
Data not yet available