TriangleNCT00049673 · REGISTRY CONDITION SEARCH
Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2023-09-13
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- minimum Age
- 16 Years
- sex
- ALL
- std Ages
- CHILD
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
- intervention Names
- Drug: prednisone
- Drug: thalidomide
- label
- Arm I
- type
- EXPERIMENTAL
- description
- Patients undergo observation.
- label
- Arm II
- type
- NO_INTERVENTION
- interventions
- arm Group Labels
- Arm I
- description
- Given orally
- name
- prednisone
- type
- DRUG
- arm Group Labels
- Arm I
- description
- Given orally
- name
- thalidomide
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 332
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Number of patients died from any cause during the study.
- measure
- Overall Survival
- time Frame
- 9 years
- secondary Outcomes
- description
- Number of patients with disease progression or death
- measure
- Disease Progression-free Survival
- time Frame
- 9 years
Full study description
- brief Summary
- 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.
- detailed Description
- OBJECTIVES: * Compare overall survival of patients with multiple myeloma treated with thalidomide and prednisone as maintenance therapy vs observation alone after autologous stem cell transplantation. * Compare progression-free survival of patients treated with these regimens. * Compare quality of life of patients treated with these regimens. * Compare toxic effects of these regimens in these patients. * Compare the objective venous thromboembolism rate in symptomatic patients treated with these regimens. OUTLINE: This is a randomized, non-blinded, multicenter study. Patients are stratified according to treatment center, age (under 60 vs 60 and over), and response to prior transplantation (complete vs incomplete). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo observation. For both arms, patients are assessed (including for quality of life) regularly throughout the treatment/observation period: at baseline, every 2 months for 6 months, every 3 months for up to 4 years, and then annually thereafter. After the treatment/observation period, patients are followed annually.. PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study within 3.5 years.
Source references
- references
- citation
- Stewart 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
- type
- RESULT
- citation
- Kovacs 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
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-353803daba2f3aeff8b2
- requested nct id
- NCT00049673
- primary nct id
- NCT00049673
- source kind
- ctgov_condition_query
- source record id
- Source null
- source file sha256
- 2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
- payload sha256
- 95a7a78e0fe74eb594db9221360c3c7e2d32bd2a9dbea676d7f7638a216d81df
- payload
- clinical indication matching status
- condition_index_match_asserted_by_registry_not_reviewed
- end exclusive
- true
- id
- nct-edge-353803daba2f3aeff8b2
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT00049673
- occurrences
- context exact
- NCT00049673
- end
- 11
- exact text
- NCT00049673
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Plasma Cell Neoplasms
- query disease state id
- ds-plasma-cell-neoplasms
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
- source file sha256
- 2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
- source json pointer
- /studies/610/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 2c3a05415ca7b9339450f949182f57860807dc7c66cc50d192e68c1940600a70
Preserved source evidence · Not medical advice