Clinical trial · Interventional
Tipifarnib and Bortezomib in Treating Patients With Relapsed Multiple Myeloma
A Dose Escalation Study of R115777 (Zarnestra) Combined With Velcade® (PS-341) in Patients With Relapsed Multiple Myeloma.
NCT00243035CI-TRIAL-00012347terminatedPhase 1 / Phase 2ClinicalTrials.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)
This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with bortezomib and to see how well they work in treating patients with relapsed multiple myeloma. Tipifarnib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tipifarnib together with bortezomib may kill more cancer cells.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage III Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage II Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| tipifarnib | Drug | Tipifarnib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bortezomib, tipifarnib)
- description
- Phase I: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral tipifarnib twice daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tipifarnib until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD. Phase II: Patients receive bortezomib as in phase I and tipifarnib as in phase I at the MTD.
- interventionNames
- Drug: bortezomib
- Drug: tipifarnib
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Maximum tolerated dose of tipifarnib as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 (phase I)
- timeFrame
- Up to day 21
- measure
- Response rate (complete response [CR] + partial response [PR]) determined using the Bladé Response criteria (phase II)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of multiple myeloma * Stage II or III disease * Relapsed disease after ≥ 2 prior therapies\*, confirmed by the presence of 1 of the following: * New lytic lesion * A 25% increase in urine or serum monoclonal protein * Patients who received prior bortezomib must have responded to therapy * Measurable disease, defined by 1 or more of the following criteria: * Serum M-component ≥ 1.0 g/dL by serum protein electrophoresis * Urine M-protein excretion \> 200 mg per 24-hour collection, by urine protein electrophoresis * Performance status - Karnofsky 60-100% * More than 8 weeks * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1,000/mm\^3 * Bilirubin ≤ 2 mg/dL * Direct bilirubin ≤ 2 times upper limit of normal (ULN) * AST or ALT ≤ 2 times ULN * Creatinine ≤ 1.5 times ULN * Calcium ≤ 12 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to swallow study medication * Capable of following directions regarding study medication, or has a daily caregiver who will be responsible for administering study medication * No peripheral neuropathy ≥ grade 2 * No hypersensitivity to any of the following: * Bortezomib * Boron * Mannitol * Imidazole compounds (e.g., clotrimazole, ketoconazole, miconazole, econazole) * No serious medical or psychiatric illness that would preclude study compliance * No other life-threatening illness (unrelated to tumor) * No other active or invasive malignancy within the past 3 years except for nonmelanoma skin cancer * No serious infection * No prior allogeneic bone marrow transplantation * More than 30 days since prior and no concurrent immunotherapy * More than 30 days since prior and no concurrent cytotoxic chemotherapy * More than 14 days since prior high-dose corticosteroids * No concurrent therapeutic corticosteroids (e.g., \> 10 mg prednisone per day) * No concurrent hormonal therapy * No concurrent antiemetic corticosteroids * More than 14 days since prior and no concurrent radiotherapy * More than 1 year since prior bortezomib * More than 14 days since prior investigational drugs * No prior tipifarnib * No other concurrent cancer-related treatment * No concurrent administration of the following enzyme-inducing anti-epileptic drugs: * Phenytoin * Phenobarbital * Carbamazepine * No concurrent magnesium- or aluminum-based antacids within 2 hours before or after tipifarnib administration * Concurrent pamidronate or other bisphosphonates allowed
References
Publications (0)
Data not yet available
No reference posted for this study.