Clinical trial · Interventional
PDD vs PAD to Treat Initially Diagnosed MM
Doxorubicin Hydrochloride Liposome vs Doxorubicin Combined With Bortizomib and Dexamethasone to Treat Initially Diagnosed Multiple Myeloma: A Randomized Prospective Clinical Study
NCT02577783CI-TRIAL-00043135unknownPhase 4ClinicalTrials.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)
The purpose of this study is to determine whether doxorubicin hydrochloride liposome is superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient with initially diagnosed 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PAD regimen: bortizomib, dexamethasone and doxorubicin | Drug | — | UNRESOLVED |
| PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PDD arm
- description
- patients involved in PDD arm will accept chemotherapy of PDD regimen (doxorubicin hydrochloride liposome plus bortizomib and dexamethasone )
- interventionNames
- Drug: PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- PAD arm
- description
- patients involved in PAD arm will accept chemotherapy of PAD regimen (doxorubicinplus bortizomib and dexamethasone )
- interventionNames
- Drug: PAD regimen: bortizomib, dexamethasone and doxorubicin
Primary outcomes (1)
- measure
- Response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed and untreated multiple myeloma patients * Patients with age between 18 and 70 years * With a evaluable disease * ECOG score ≤2 * NE≥1.0×10E9 /L, Plt≥50×10E9 /L, Hb≥70 g/L * AST, ALT, ALP≤3×ULN, serum BIL≤ULN * LVEF≥ 50% * Not in pregnancy * Written informed consent are acquired Exclusion Criteria: * Severe heart failure (NYHA grade II or higher) * Active and uncontrolled severe infection * HIV positive * Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride iposome or doxorubicin * Grade 2 or higher peripheral neuropathy before treatment * Have suffered any other malignancy in past 5 years * Females in lactation * Other situations that investigators consider as contra-indication for this study
References
Publications (0)
Data not yet available
No reference posted for this study.