Clinical trial · Interventional
Bortezomib (Velcade) Post Allogenic Peripheral Blood Stem Cell Transplantation for Myeloma
A Phase II Trial of Bortezomib (Velcade) After Allogenic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma
NCT00504634CI-TRIAL-00005488completedPhase 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)
Primary Objective: 1\. To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma. Secondary Objective 1\. To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation.
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 |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib
- description
- 1 mg/m\^2 intravenous (IV) Days 1, 4, 8, and 11.
- interventionNames
- Drug: Bortezomib
Primary outcomes (1)
- measure
- Number of Participants with Complete Response (CR)
- timeFrame
- 6 weeks from beginning treatment
- description
- Response rate (CR), evaluated within 6 weeks of beginning treatment, assessed using The European Group for Blood and Bone Marrow Transplant/International Bone Marrow Transplant Registry (EBMT/IBMTR) response criteria of Complete Response (CR), Minimal Response (MR), No Change (NC), or Progressive Disease (PD).
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with multiple myeloma at least 3 months post allogeneic transplant who either failed to achieve a complete remission or are relapsing. * Allograft performed from a related donor who is HLA-compatible (5/6 or 6/6), or class I serologic match and class II molecular matched unrelated donor). * Zubrod Points Scale (PS) \< 2, life expectancy is not severely limited by concomitant illness. * Patient willing and able to sign informed consent. * Patients less than 70 years of age. Exclusion Criteria: * Active Central Nervous System (CNS) disease. * Uncontrolled acute or chronic Graft-versus-host disease (GVHD).
References
Publications (0)
Data not yet available
No reference posted for this study.