Clinical trial · Interventional
Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma
A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma
NCT00049673CI-TRIAL-00069524completedPhase 3Results postedClinicalTrials.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. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for 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 (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: prednisone
- Drug: thalidomide
- type
- NO_INTERVENTION
- label
- Arm II
- description
- Patients undergo observation.
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 9 years
- description
- Number of patients died from any cause during the study.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma as evidenced by one of the following: * 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 less than 10% plasma cells with at least 1 bony lesion and meets the M-protein criteria as below * Detectable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR * Urinary excretion of light chain (Bence Jones) protein at least 1.0 gm/24 hrs if only light chain disease (urine M-protein) was present at initial diagnosis * Previously treated with autologous stem cell transplantation after high-dose melphalan (200 mg/m\^2) within the past 60-100 days * Received transplantation within 1 year of the beginning of initial chemotherapy for multiple myeloma * No evidence of disease progression PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * No prior hereditary hypercoaguable disorder * Granulocyte count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and/or ALT no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN Renal * Creatinine no greater than 3 times ULN Cardiovascular * No prior spontaneous deep vein thrombosis within the past 5 years * Catheter-associated thrombus allowed * No uncontrolled hypertension Pulmonary * No prior pulmonary embolism within the past 5 years Other * No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or any cancer treated more than 5 years prior to study entry and presumed cured * No prior gastric ulceration or bleeding within the past 5 years * No prior documented lupus anti-coagulant or anti-phospholipid antibody * Not pregnant or nursing * Negative pregnancy test * Fertile female patients must use 2 effective methods of contraception for 1 month prior, during, and 1 month after study participation * Male patients must use effective barrier contraception during and for 1 month after study participation * No avascular necrosis of the hips or shoulders * No grade 2 or greater peripheral neuropathy causing symptomatic dysfunction (vincristine-induced sensory symptoms allowed) * No diabetes with end-organ damage defined as: * Documented diabetic neuropathy * Retinal vascular proliferation requiring treatment * Cardiovascular disease requiring active therapy * Willing to complete quality of life questionnaires * Employment does not prohibit the use of sedatives * No other major medical illness or condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior double autologous or allogeneic hematopoietic stem cell transplantation * No prior thalidomide Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No other concurrent anti-cancer therapy * No other concurrent investigational therapy
References
Publications (2)
- RESULTStewart AK, Trudel S, Bahlis NJ, White D, Sabry W, Belch A, Reiman T, Roy J, Shustik C, Kovacs MJ, Rubinger M, Cantin G, Song K, Tompkins KA, Marcellus DC, Lacy MQ, Sussman J, Reece D, Brundage M, Harnett EL, Shepherd L, Chapman JA, Meyer RM. A randomized phase 3 trial of thalidomide and prednisone as maintenance therapy after ASCT in patients with MM with a quality-of-life assessment: the National Cancer Institute of Canada Clinicals Trials Group Myeloma 10 Trial. Blood. 2013 Feb 28;121(9):1517-23. doi: 10.1182/blood-2012-09-451872. Epub 2013 Jan 7. PMID 23297129
- DERIVEDKovacs MJ, Davies GA, Chapman JA, Bahlis N, Voralia M, Roy J, Kouroukis CT, Chen C, Belch A, Reece D, Zhu L, Meyer RM, Shepherd L, Stewart KA. Thalidomide-prednisone maintenance following autologous stem cell transplant for multiple myeloma: effect on thrombin generation and procoagulant markers in NCIC CTG MY.10. Br J Haematol. 2015 Feb;168(4):511-7. doi: 10.1111/bjh.13176. Epub 2014 Oct 10. PMID 25302852