Clinical trial · Interventional
Bortezomib in Treating Patients With Multiple Myeloma Who Have Undergone an Autologous Peripheral Blood Stem Cell Transplant
A Phase I Study of Bortezomib During Maintenance Phase After High Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
- 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)
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib after an autologous peripheral blood stem cell transplant may stop the growth of any cancer cells that remain after transplant. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib in treating patients with multiple myeloma who have undergone an autologous peripheral blood stem cell transplant.
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 and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib
- description
- Bortezomib is administered as a 5 second IV bolus on days 1, 4, 8,11 or 1,8 and 15 of a 21-35 days cycle (Depending on the Dosing schedule). The dosage will be calculated based on actual weight of the patient unless the actual weight is greater than 40% above the ideal body weight. In this instance the dosage will be based on the adjusted ideal body weight. The Adjusted IBW (kg) = IBW + 0.25 x (actual body weight - IBW). The dosage will be adjusted based on the safety and toxicity profile, until a MTD is determined.
- interventionNames
- Drug: bortezomib
Primary outcomes (2)
- measure
- Maximum tolerated dose
- timeFrame
- At course 8
- measure
- Safety and tolerability
- timeFrame
- At course 8
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Must have completed high-dose melphalan and autologous peripheral blood stem cell transplantation * Transplant must have been completed 30-120 days ago * Must not be receiving maintenance therapy * Patients must have received 200 mg/m² of melphalan intravenously as a conditioning regimen (no dose reduction allowed) * No evidence of amyloidosis * No available donor PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 or Karnofsky PS 60-100% * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 75,000/mm\^3 * Bilirubin ≤ 1.5 times upper limit of normal * Transaminase ≤ 3 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must have a negative HIV test * No baseline neurological disease \> grade I * No cranial nerve palsy * No demonstrated resistance to bortezomib * No history of allergic reactions attributed to bortezomib, boron, or mannitol * No cardiac arrhythmia * No unstable angina pectoris * No symptomatic congestive heart failure * No ongoing or active infection * No other uncontrolled illness * No psychiatric illness or social situations that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No other concurrent anticancer therapies or agents * No other concurrent investigational agents * Not receiving maintenance therapy after prior stem cell transplantation on another clinical trial
References
Publications (0)
Data not yet available