TriangleNCT00432458 · REGISTRY CONDITION SEARCH
Zoledronate With or Without Thalidomide in Treating Patients With Early Stage 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
- 2012-07-04
RATIONALE: Zoledronate may prevent bone loss and stop the growth of cancer cells in bone. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet know whether giving zoledronate together with thalidomide is more effective than zoledronate alone in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying zoledronate and thalidomide see how well they work compared with zoledronate alone in treating patients with early stage multiple myeloma.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Time to Disease Progression (TTP)
12-month Progression-free Survival (PFS)
Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment
Duration of Response (Complete Response, Partial Response, and Very Good Partial Response)
Time to Subsequent Treatment
Time to Treatment Failure
Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma (MM) * Previously untreated asymptomatic disease * No requirement for immediate chemotherapy for active MM, such as hypercalcemia from myeloma or painful bone lesions * No solitary plasmacytoma * Measurable or evaluable disease as defined by one of the following: * Serum monoclonal protein ≥ 1.0 g by protein electrophoresis * More than 200 mg of monoclonal protein in the urine by 24-hour electrophoresis * Measurable soft tissue plasmacytoma by physical exam with ruler or by MRI or positron emission tomography/CT scan * If the only measurable lesion is the plasmacytoma, it must be ≥ 1.5 cm in 1 dimension * Must have ≥ 10% plasma cells as measured on the bone marrow aspirate, bone marrow biopsy, or labeling index * No amyloidosis PATIENT CHARACTERISTICS: * Performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8.0 g/dL * Creatinine ≤ 2.0 mg/dL (elevation above normal range should not be felt to be related to myeloma) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 4 weeks after completion of study treatment * No uncontrolled infection * No other active malignancy * No New York Heart Association class III or IV heart disease * No pre-existing neuropathy ≥ grade 2 * No concurrent major dental work PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior corticosteroids (for nonmalignant disorders) allowed * Prior therapy with experimental agents not shown to have significant activity in MM, such as clarithromycin, dehydroepiandrosterone, and anakinra allowed * No prior thalidomide or corticosteroids for MM * No more than 3 doses of IV zoledronate or pamidronate within the past 12 months * At least 3 months since prior radiotherapy, including radiotherapy for solitary plasmacytoma * No concurrent oral bisphosphonate therapy for osteoporosis
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Thalidomide (Thal) + Zolendronic acid (ZLD)
- intervention Names
- Drug: Thalidomide
- Drug: zoledronic acid
- label
- Arm I: Thal/ZLD
- type
- EXPERIMENTAL
- description
- Zoledronic acid (ZLD)
- intervention Names
- Drug: zoledronic acid
- label
- Arm II: ZLD
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Arm I: Thal/ZLD
- description
- 200 mg orally on days 1-28 of 28 day cycle
- name
- Thalidomide
- type
- DRUG
- arm Group Labels
- Arm I: Thal/ZLD
- Arm II: ZLD
- description
- 4 mg\^2 by IV on day 1 every 84 days for 1 year and once per year thereafter
- name
- zoledronic acid
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 68
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Time to disease progression (TTP) was defined as the time from randomization to the earliest documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method, a two-sided (stratified) log-rank test was calculated.
- measure
- Time to Disease Progression (TTP)
- time Frame
- randomization to progression (up to 5 years)
- secondary Outcomes
- description
- PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of randomization.
- measure
- 12-month Progression-free Survival (PFS)
- time Frame
- 12 months
- description
- Response is defined as follows: * CR: Complete disappearance of M-protein from serum \& urine on immunofixation, \<5% plasma cells in bone marrow (BM) * VGPR: \>=90% reduction in serum M-component; Urine M-Component \<100 mg per 24 hours; \<=5% plasma cells in BM * PR: \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels
- measure
- Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment
- time Frame
- 12 months
- description
- Duration of response (DOR) is defined as the time from first documentation of response (CR, VGPR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method
- measure
- Duration of Response (Complete Response, Partial Response, and Very Good Partial Response)
- time Frame
- time from start of response to progression (up to 5 years)
- description
- Time to subsequent treatment (TTS) was defined as time from end of active (protocol) treatment to the start of subsequent treatment for participants with progressive disease. The median TTS with 95% CI was estimated using the Kaplan Meier method
- measure
- Time to Subsequent Treatment
- time Frame
- time from end of treatment to subsequent treatment (up to 5 years)
- description
- Time to treatment failure (TTF) was defined as the time from randomization to the date at which the patient was removed from (protocol) treatment due to disease progression, unacceptable toxicity, participant refusal or death. The median TTF with 95% CI was estimated using the Kaplan Meier method
- measure
- Time to Treatment Failure
- time Frame
- time from randomization to treatment failure (up to 5 years)
- description
- Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 2. Description of Grades: Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death
- measure
- Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events
- time Frame
- During treatment (up to 5 years)
Full study description
- brief Summary
- RATIONALE: Zoledronate may prevent bone loss and stop the growth of cancer cells in bone. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet know whether giving zoledronate together with thalidomide is more effective than zoledronate alone in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying zoledronate and thalidomide see how well they work compared with zoledronate alone in treating patients with early stage multiple myeloma.
- detailed Description
- OBJECTIVES: Primary * Compare time to progression in patients with early stage multiple myeloma treated with zoledronate with or without thalidomide. Secondary * Compare the response rate, 1-year progression-free survival rate, duration of response, and time to next therapy in patients treated with these regimens. * Assess differences in toxicity of these regimens in these patients. OUTLINE: This is a multicenter, randomized study. Patients are stratified according to the presence of lytic lesions on metastatic bone survey (yes vs no), beta-2 microglobulin level (high vs normal), and bone marrow labeling index (high \[\> 1.0%\] vs low \[≤ 1.0%\]). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral thalidomide on days 1-28. Treatment with thalidomide repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive zoledronate IV over 15 minutes on day 1. Treatment with zoledronate repeats every 84 days for 1 year and once a year thereafter in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive zoledronate IV over 15 minutes on day 1. Treatment repeats every 84 days for 1 year and once a year thereafter in the absence of disease progression or unacceptable toxicity. Blood samples are collected for research studies at baseline and after courses 3, 6, 9, and 12. Bone marrow aspirates are performed at baseline and after courses 6 and 12. Samples are evaluated for bone marrow angiogenesis; vascular endothelial growth factor (VEGF), VEGF receptor 1 (VEGFR-1), and VEGFR-2 expression; bone marrow angiogenesis-VEGF relationship; bone marrow angiogenesis/apoptosis rate relationship; bone marrow angiogenesis/plasma cell (PC) proliferation rate relationship; VEGF expression/apoptosis rate relationship; and VEGFR expression/PC proliferation rate relationship. After completion of study treatment, patients are followed every 6 months for up to 5 years. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Source references
- references
- citation
- Witzig TE, Laumann KM, Lacy MQ, Hayman SR, Dispenzieri A, Kumar S, Reeder CB, Roy V, Lust JA, Gertz MA, Greipp PR, Hassoun H, Mandrekar SJ, Rajkumar SV. A phase III randomized trial of thalidomide plus zoledronic acid versus zoledronic acid alone in patients with asymptomatic multiple myeloma. Leukemia. 2013 Jan;27(1):220-5. doi: 10.1038/leu.2012.236. Epub 2012 Aug 20.
- pmid
- 22902362
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice