Phase 3
Completed N=68
Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma
Source: ClinicalTrials.gov NCT00432458 ↗Enrolled (actual)
68
Serious AEs
5.9%
Results posted
Jul 2012
Primary outcomePrimary: Time to Disease Progression (TTP) — 2.4; 1.2 years — p=0.02
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Disease Progression (TTP) |
2.4; 1.2 | 0.02 sig |
| SECONDARY 12-month Progression-free Survival (PFS) |
30; 18 | 0.0048 sig |
| SECONDARY 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 |
13; 0 | <0.001 sig |
| SECONDARY Duration of Response (Complete Response, Partial Response, and Very Good Partial Response) |
3.3 | — |
| SECONDARY Time to Subsequent Treatment |
— | — |
| SECONDARY Time to Treatment Failure |
16.5; 11.1 | — |
| SECONDARY Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events |
17; 13 | — |
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
Data sourced from ClinicalTrials.gov (NCT00432458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.