Clinical trial · Interventional
Two Cycles of PAD Combination by AHCT in MM
Two Cycles of Pad Combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) Followed by Autologous Hematopoietic Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients
- 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)
Based the proven efficacy and the ability to induce rapid response of various combinations of bortezomib including PAD combination in refractory and newly diagnosed patients with Multiple Myeloma, the investigators intend to investigate the efficacy of 2 cycles of PAD combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) and to examine the feasibility of harvesting G-CSF mobilized PBSC and performing early AHCT after 2 cycles of PAD.
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 |
|---|---|---|---|
| PAD combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- VAD combination
- description
- * vincristine 0.4mg iv on D1-4 * doxorubicin 9mg/m2 iv on D1-4 * dexamethasone 40mg/d po on D1-4,9-12,17-20 * Many physicians use vincristine, doxorubicin, and dexamethasone (VAD) for three to four months as induction therapy (Alexandrian et al, 1990). VAD produces partial response (PR) in about 50% patients, with complete response (CR) observed in 5%-10% patients (Kyle et al, 2004).
- interventionNames
- Drug: PAD combination
Primary outcomes (1)
- measure
- response rates and toxicities.
- timeFrame
- 2.5 years
- description
- To investigate the effectiveness of bortezomib, doxorubicin and dexamethasone (PAD) combination therapy in the treatment of previously untreated patients with multiple myeloma who are eligible for autologous hematopoietic cell transplantation (AHCT). The effectiveness will be evaluated in terms of response, response rates, and toxicities.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed symptomatic MM (see Appendix I) * Patients should be eligible for AHCT. * Patients should have measurable serum or urine paraprotein. * The performance status of the patients should be 70 or over by Karnofsky performance scale * Adequate hepatic and renal function: serum bilirubin \< 1.5 x the upper limit of normal (ULN), serum alanine aminotransferase (ALT)/aspartate aminotransaminase (AST) values \< 2.5 x ULN, serum creatinine \< 1.5 x ULN * Adequate cardiac function: ejection fraction \> 40% by echocardiogram or radionuclide heart scan Exclusion Criteria: * prior chemotherapy for myeloma except 4 days of dexamethasone up to 40 mg per day or localized radiotherapy or plasmapheresis for the treatment of clinically significant hyperviscosity syndrome * have a peripheral neuropathy of grade 2 or more within 14 days of enrollment. * significant infection
References
Publications (0)
Data not yet available