Clinical trial · Interventional
Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1/2a Study to Evaluate Safety and Efficacy of Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory 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)
Multiple myeloma remains incurable disease in most patients . Cellular immunotherapy using dendritic cells is emerging as a useful immunotherapeutic modality to treat multiple myeloma. Vax-DC/MM is an potent immunotherapeutic agent generated by dendritic cells loaded with the ultraviolet B-irradiated autologous human myeloma cells. The main purpose of this study is to examine the safety and efficacy of Vax-DC/MM in patients with relapsed or refractory 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 |
|---|---|---|---|
| Vax-DC/MM | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vax-DC/MM
- interventionNames
- Biological: Vax-DC/MM
Primary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- 1 years
- description
- Adverse events were assessed using the National Cancer Institute common toxicity criteria (NCI-CTC) for adverse events version 4.0 every injection of Vax-DC/MM
Secondary outcomes (2)
- measure
- Clinical response after completion of Vax-DC/MM injection
- timeFrame
- 2 year
- description
- The International Myeloma Working Group uniform criteria were used to assess the clinical response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory multiple myeloma who received at least one prior therapy including thalidomide, bortezomib, or lenalidomide-containing regimen * Subjects with measurable disease defined as at least one of the following Serum M-protein ≥ 1.0 g/dL Urine M-protein ≥ 400 mg/24hr * Eastern Cooperative Oncology Group Performance Status ≤ 2 * Hemoglobin ≥ 8 g/dL (≥ 4.96 mol/L): Prior red blood cell transfusion or recombinant human erythropoietin use is allowed. * Absolute neutrophil count (ANC) ≥ 1.0 x 109/L * Aspartate aminotransferase (AST) \< 3 times the upper limit of normal * Alanine aminotransferase (ALT) \< 3 times the upper limit of normal * Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion Criteria: * Smoldering or indolent myeloma * Uncontrolled or severe cardiovascular disease (cardiac ejection fraction\<0.5, Severe conduction disorder ) * Sepsis or current active infection * Pregnancy or breastfeeding * Received other immunotherapy treatment * Clinically significant autoimmune disease * Serious medical or psychiatric illness likely to interfere with participation in this clinical study
References
Publications (0)
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