Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Multiple Myeloma
Comparative Study of Dexamethasone vs Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone vs no Additional Treatment as Maintenance Therapy in Non-Progressing Patients
NCT00002678CI-TRIAL-00044417completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 patients with multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Melphan plus prednisone
- description
- melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; No treatment after stable response.
- interventionNames
- Drug: melphalan
- Drug: prednisone
- type
- ACTIVE_COMPARATOR
- label
- Melphan, prednisone pluse dexamethasone
- description
- melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; dexamethasone qd x 4 q 28 days after non-progression
- interventionNames
- Drug: dexamethasone
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven previously untreated stage I-III multiple myeloma * Patients with stage I disease must be symptomatic * Must meet at least 1 of the following conditions: * Plasma cells in osteolytic lesion or soft tissue tumor biopsy * At least 10% plasmacytosis in bone marrow aspirate and/or biopsy * Less than 10% plasma cells in bone marrow but at least 1 bony lesion * Detectable serum M-component of IgG, IgA, IgD, or IgE * If only light chain disease (urine M-protein) present, urinary excretion of light chain (Bence Jones) protein must be at least 1.0 g/24 hours PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-4 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other concurrent serious illness * Concurrent diabetes allowed, at the discretion of the treating physician, if changes in insulin requirements can be managed * No other prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunizations * No concurrent filgrastim (G-CSF) or other growth factors as prophylaxis * Concurrent epoetin alfa for anemia allowed Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior dexamethasone or prednisone with radiotherapy for spinal cord compression allowed if cumulative dexamethasone dose no greater than 120 mg and cumulative prednisone dose no greater than 792 mg * Prior or concurrent corticosteroids for hypercalcemia allowed Radiotherapy: * See Endocrine therapy * Prior focal radiotherapy allowed * Concurrent focal radiotherapy during induction allowed * Concurrent radiotherapy for palliation (e.g., painful osteolytic lesions or spinal cord compression) allowed Surgery: * At least 2 years since prior surgery for radiologic or endoscopic diagnosis of gastric or duodenal ulcer Other: * At least 2 years since prior medication for radiologic or endoscopic diagnosis of gastric or duodenal ulcer * Prior or concurrent bisphosphonates for hypercalcemia allowed
References
Publications (3)
- RESULTShustik C, Belch A, Robinson S, Rubin SH, Dolan SP, Kovacs MJ, Grewal KS, Walde D, Barr R, Wilson J, Gill K, Vickars L, Rudinskas L, Sicheri DA, Wilson K, Djurfeldt M, Shepherd LE, Ding K, Meyer RM. A randomised comparison of melphalan with prednisone or dexamethasone as induction therapy and dexamethasone or observation as maintenance therapy in multiple myeloma: NCIC CTG MY.7. Br J Haematol. 2007 Jan;136(2):203-11. doi: 10.1111/j.1365-2141.2006.06405.x. PMID 17233817
- RESULTShustik C, Belch A, Robinson S, et al.: Dexamethasone (dex) maintenance versus observation (obs) in patients with previously untreated multiple myeloma: a National Cancer Institute of Canada Clinical Trials Group study: MY.7. [Abstract] J Clin Oncol 22 (Suppl 14): A-6510, 560s, 2004.
- RESULTShustik C, Belch A, Meyer R, et al.: Melphalan-dexamethasone is not superior to melphalan-prednisone as induction therapy in multiple myeloma. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1191, 2001.