Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Multiple Myeloma
Phase II Trial of Doxil, Vincristine and Decadron in Multiple Myeloma
NCT00003493CI-TRIAL-00011400completedPhase 2ClinicalTrials.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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, vincristine, and dexamethasone in treating patients with newly diagnosed or previously treated 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 |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven newly diagnosed or previously treated multiple myeloma At least one chemotherapy regimen and no more than four regimens Pancytopenia related to multiple myeloma allowed At least 50% plasma cells in the bone marrow Splenomegaly OR Plasma cell leukemia No solitary bone or solitary extramedullary plasmacytoma PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 2,500/mm3 OR neutrophil count at least 1,000/mm3 (previously treated patients with platelet count at least 75,000/mm3 must have a neutrophil count of greater than 500/mm3) Platelet count at least 75,000/mm3 (previously treated patients must have platelet count at least 45,000/mm3) Thrombocytopenia related to idiopathic thrombocytopenic purpura or B12 or folate deficiency allowed Hepatic: Bilirubin no greater than upper limit of normal (ULN) ALT or AST no greater than 2 times ULN (unless greater than 1/3 of liver is involved by tumor, in which case ALT or AST must be no greater than 5 times ULN) Renal: Not specified Cardiovascular: LVEF at least 50% by MUGA scan or echocardiogram No New York Heart Association class II or greater cardiac disease Other: Not pregnant or nursing Fertile patients must use effective contraception No prior malignancies within 5 years, except: Adequately treated basal or squamous cell skin cancer Adequately treated carcinoma in situ of the cervix No uncontrollable physical, mental, or emotional disorders No history of hypersensitivity to doxorubicin HCL or liposomal or PEGylated formulations of other drugs No active infection requiring IV antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Patients who have previously failed treatment with doxorubicin HCl liposome, vincristine, and dexamethasone (VAD) are allowed if anthracycline therapy has been at least 6 months, and prior anthracycline exposure no greater than 300 mg/m2 No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Concurrent radiotherapy to control pain or prevent fractures allowed Surgery: Prior surgery allowed if recovered
References
Publications (0)
Data not yet available
No reference posted for this study.