Phase 3
N=148
Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma
Multiple Myeloma · Auto Stem Cell Transplant
Bottom Line
View on ClinicalTrials.gov: NCT01241708 ↗Enrolled (actual)
148
Serious AEs
47.2%
Results posted
Sep 2025
Primary outcome: Primary: To Determine the Progression-free Survival of Patients With Multiple Myeloma Treated With Tandem Cycles of High-dose Melphalan Followed by High-dose Melphalan in Combination With Bortezomib With Autologous HSC Transplantation. — 73.8 Percent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bortezomib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hackensack Meridian Health
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Determine the Progression-free Survival of Patients With Multiple Myeloma Treated With Tandem Cycles of High-dose Melphalan Followed by High-dose Melphalan in Combination With Bortezomib With Autologous HSC Transplantation. |
73.8 | — |
| SECONDARY To Determine the Response Rate of Patients With Multiple Myeloma Treated With High-dose Melphalan or High-dose Melphalan in Combination With Bortezomib Given in Tandem Transplants. |
86 | — |
| SECONDARY To Determine the Overall Survival of Patients With Multiple Myeloma Treated With High-dose Melphalan or High-dose Melphalan in Combination With Bortezomib Given in Tandem Transplants. |
76 | — |
Summary
High dose chemotherapy with stem cell transplantation is commonplace in the treatment of multiple myeloma. This treatment uses a chemotherapy drug called Melphalan that has been used in several thousand bone marrow transplant recipients worldwide for the same or similar disorders.
Eligibility Criteria
Changed from: Inclusion Criteria:
- Confirmed diagnosis of multiple myeloma with either Durie-Salmon stage I, II, or III or ISS stage I, II or III, less than 12 months since initiation of systemic therapy
- ≥8x106 CD34+cells/kg available in cryopreservation in aliquots appropriate for tandem transplants
- Age: 18-75 years at time of transplantation
- KPS 70-100%
- Recovery from complications of prior therapies
- Gender: There is no gender restriction
Exclusion Criteria
- Diagnosis other than multiple myeloma
- Chemotherapy or radiotherapy within 8 days of initiating treatment in this study
- Prior autologous or allogeneic transplantation (except as enrolled into this study)
- Uncontrolled bacterial, viral, fungal or parasitic infections
Data sourced from ClinicalTrials.gov (NCT01241708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.