Clinical trial · Interventional
Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma
A Randomized Phase II Study of Bisphosphonate: Zoledronic Acid (Zometa) in the Management of Asymptomatic/Early Stage Multiple Myeloma: Hoosier Oncology Group MM02-35
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to low patient enrollment.
Summary
Brief summary (as posted)
Evidence for the beneficial effects of bisphosphonates on bone resorption in multiple myeloma has been reported extensively, showing reductions in skeletal events and improvement of several biochemical variables in bone resorption. Zoledronic acid (Zometa®, CGP42446) is the most potent clinically available bisphosphonates, with the largest therapeutic ratio between the desired inhibition of calcium resorption and the unwanted inhibition of mineralization in vitro of all the bisphosphonates. This trial will investigate the efficacy of zoledronic acid in preventing skeletal events in patients with asymptomatic/early stage 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 | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic Acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months.
- interventionNames
- Drug: Zoledronic Acid
- type
- NO_INTERVENTION
- label
- B
- description
- Patients will be randomly assigned by study number to observation only.
Primary outcomes (1)
- measure
- · To examine the effect of intravenous zoledronic acid at the dose of 4 mg given every three months compared with observation, on percent change in bone mineral density of the spine at one year in patients with asymptomatic, smoldering and stage I MM.
- timeFrame
- 18 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of asymptomatic multiple myeloma as defined by the criteria below: * Presence of bone marrow clonal plasma cells (more than 10%) * Presence of an M-protein in serum and/or urine (no concentration specified) * Serum calcium \< 12 mg/dl within 14 days prior to registration. Less than 3 lytic lesions, no pathologic fractures and no osteopenia noted on skeletal survey * No symptoms of hyperviscosity, amyloidosis or recurrent infection * Bone mineral density with a T score higher than -2.0 standard deviation (not have osteoporosis) within 28 days prior to registration * Negative pregnancy test Exclusion Criteria: * No previous treatment with bisphosphonates * No disorders of the parathyroid or thyroid glands * No current breastfeeding * No prior malignancy is allowed except for adequately treated in situ cervical cancer, Gleason \< grade 7 prostate cancers
References
Publications (0)
Data not yet available