Clinical trial · Interventional
Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
A Randomized Phase II Dose Finding Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma
NCT00006890CI-TRIAL-00044397completedPhase 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: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. Prednisone may be effective in preventing relapse of multiple myeloma. PURPOSE: Randomized phase II trial to compare the effectiveness of two doses of thalidomide combined with prednisone following peripheral stem cell transplantation in treating patients who have 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prednisone | Drug | Prednisone | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prednisone plus Thalidomide
- description
- After Autologous Stem Cell Infusion
- interventionNames
- Drug: prednisone
- Drug: thalidomide
Primary outcomes (1)
- measure
- incidence of drop-out or dose reduction
- timeFrame
- 2 years
- description
- incidence of drop-out or dose reduction due to toxicity within 6 months from the start of treatment.
Secondary outcomes (3)
- measure
- Response rate
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven multiple myeloma Initial diagnosis must have been confirmed by one of the following prior to initial treatment for multiple myeloma: Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells Bone marrow aspirate and/or biopsy demonstrating at least 10% plasmacytosis Bone marrow containing less than 10% plasma cells but with at least 1 bony lesion and the M-protein criteria outlined below Measurable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR If only light chain disease (urine M-protein only) present, then the urinary excretion of light chain (Bence Jones) protein must have been at least 1.0 g/24 hours at time of initial diagnosis Must have undergone autologous stem cell transplantation within 1 year of beginning initial chemotherapy for multiple myeloma Must be randomized 60-100 days after autologous stem cell infusion No evidence of progressive disease PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: See Disease Characteristics Granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: AST and/or ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN Renal: Creatinine no greater than 3 times ULN Cardiovascular: No uncontrolled hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile female patients must use 2 effective methods of contraception (1 barrier and 1 hormonal) during and for 1 month after study Fertile male patients must use effective barrier contraception during and for 1 month after study No other medical condition that would preclude long term use of prednisone or thalidomide No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No diabetes with end stage organ damage No history of gastric ulceration or bleeding No avascular necrosis of the hips No peripheral neuropathy causing symptomatic dysfunction Sensory symptoms induced by vincristine allowed No demonstrated hypersensitivity to thalidomide or its components No other major medical illness that would increase risk or preclude study No employment that prohibits the use of sedatives (due to known effect of thalidomide) PRIOR CONCURRENT THERAPY: Biologic: See Disease Characteristics No prior thalidomide Chemotherapy: See Disease Characteristics Endocrine: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent anticancer treatment No other concurrent investigational therapy
References
Publications (2)
- RESULTStewart AK, Chen CI, Howson-Jan K, White D, Roy J, Kovacs MJ, Shustik C, Sadura A, Shepherd L, Ding K, Meyer RM, Belch AR. Results of a multicenter randomized phase II trial of thalidomide and prednisone maintenance therapy for multiple myeloma after autologous stem cell transplant. Clin Cancer Res. 2004 Dec 15;10(24):8170-6. doi: 10.1158/1078-0432.CCR-04-1106. PMID 15623591
- RESULTStewart KA, Chen C, Howson-Jan K, et al.: A randomized phase II dose-finding trial of thalidomide and prednisone as maintenance therapy for myeloma following autologous stem cell transplant. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1073, 2002.