Clinical trial · Interventional
a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients
Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk 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)
The clinical trial was conducted in a cohort of young, high-risk myeloma patients who were designed to receive a combination of high-dose chemotherapy with allogeneic or autologous hematopoietic stem cell transplantation. The objective was to assess the progression free survival (PFS), overall survival (OS),and overall response rate (ORR) of the overall treatment.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 1Q21 Amplification | — | UNRESOLVED | — |
| Complex Karyotype | — | UNRESOLVED | — |
| Extramedullary Plasmacytoma | Extraosseous Plasmacytoma | ALIAS | 0.90 |
| Loss of Chromosome 17p | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Plasma Cell Leukemia | Plasma Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
| t(14;16) | — | UNRESOLVED | — |
| T(14;20) | — | UNRESOLVED | — |
| t(4;14) | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2 | Procedure | — | UNRESOLVED |
| Fludarabine Injection | Drug | Fludarabine | ALIAS |
| Melphalan Given IV | Drug | — | UNRESOLVED |
| PI and dexamethasone as maintenance therapy | Drug | — | UNRESOLVED |
| PI+IMids+Dexamethasone as Consolidated Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A:Allogeneic Stem Cell Transplant Group
- description
- Fludarabine+Melphalan followed by Allogeneic SCT.
- interventionNames
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Drug: Melphalan Given IV
- Drug: Fludarabine Injection
- Drug: PI and dexamethasone as maintenance therapy
- type
- EXPERIMENTAL
- label
- B:Autologous Stem Cell Transplant
- description
- Melphalan followed by Autologous SCT.
- interventionNames
- Procedure: Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2
- Drug: Melphalan Given IV
- Drug: PI and dexamethasone as maintenance therapy
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical diagnosis of high-risk multiple myeloma In addition, patients must meet at least one of the following criteria I-IX (I-VIII at time of diagnosis or pre-autograft): I.Complex karyotype II.Fluorescent in situ hybridization (FISH) translocation 4:14 or 14:16, III.FISH translocation 1q21, IV.FISH deletion 17p, V.R-ISS III stage, VI.Two or more high-risk cytogenetic abnormalities exist VII.Plasma cell leukemia VIII.Extramedullary plasmacytoma IX.Recurrent or non-responsive (less than partial remission \[PR\]) MM after at least 4 cycles of PI/IMids-based chemotherapy 2. candidate for high-dose chemotherapy with stem cell transplantation 3. ECOG performance status score of 0,1,or2 - Exclusion Criteria: 1. The current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance of disease, Waldenstr o m macroglobulinemia. 2. during the first 5 years of the study, there were no other malignancies, including basal cell carcinoma or in situ cervical cancer. 3. according to the National Cancer Institute general toxicity criteria (NCI CTC), subjects had peripheral neuropathy of grade 2 or above: 4. were enrolled within 6 months before had a myocardial infarction, or New York Heart Association (NYHA) III or IV heart failure ,uncontrolled angina, uncontrolled severe ventricular arrhythmias or ECG evidence of acute ischemia or conduction system abnormalities and activity the clinical significance of pericardial disease, or cardiac amyloidosis -
References
Publications (0)
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