Clinical trial · Interventional
VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)
Evaluation of Safety and Efficacy of VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following High-Dose Melphalan Treatment and Autologous PBSCT (Minimal Residual Disease, Partial Remission or Stable Disease)
- 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)
Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and tolerability, as well as the efficacy, of maintenance treatment with VELCADE (bortezomib) in patients with multiple myeloma with detectable disease activity following tandem high-dose chemotherapy and autologous SCT. The time from SCT to the initiation of VELCADE treatment will be 3 to 6 months.
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 (0)
[]Primary outcomes (1)
- measure
- Primary endpoints are to study the safety of four cycles of VELCADE in patients with multiple myeloma following high-dose chemotherapy and autologous PBSCT.
Secondary outcomes (4)
- measure
- The secondary objectives of this study are to assess the efficacy of four cycles of VELCADE at two different dose levels as maintenance treatment in patients with multiple myeloma
- measure
- and detectable residual disease following high-dose chemotherapy and autologous PBSCT
- measure
- to assess the 2 year progression-free survival
- measure
- and to assess the 2 year overall survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient having received tandem transplants with high-dose melphalan and autologous PBSCT within 3-6 months prior to inclusion into this protocol * Patients with measurable minimal residual disease (very good partial remission \[VGPR\]) or patients in partial remission (PR) or patients with stable disease (SD) at the time of inclusion in the study * Patient must agree to participate in the study. * Patient agrees to use an appropriate method of contraception. * Willingness and ability to comply with the study protocol for the duration of the study Exclusion Criteria: * Patient showing signs of disease progression * Patient has a platelet count \< 100 x 10\^9/L within 14 days before enrollment. * Patient has an absolute neutrophil count \< 1.0 x 10\^9/L within 14 days before enrollment. * Patient has a calculated or measured creatinine clearance \< 30 mL/minute within 14 days before enrollment. * Patient has \>= Grade 2 peripheral neuropathy within 14 days before enrollment. * Patient has hypersensitivity to bortezomib, boron, or mannitol. * Patient has received prior treatment with bortezomib * Patient is pregnant or nursing * Patient has received other investigational drugs within 14 days before enrollment * Patient has progressive disease * Patient has a Karnofsky performance status \< 60% * Patient has a life expectancy of \< 3 months * Patient has received disease modifying agents following autologous stem cell transplantation other than aminobisphosphonates such as interferon-alpha or glucocorticosteroids * Patient currently enrolled in another clinical research study and/or receiving an investigational reagent for any reason.
References
Publications (0)
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