A Phase 3 interventional study of Bortezomib in Multiple Myeloma and Auto Stem Cell Transplant, sponsored by Hackensack Meridian Health. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Hackensack Meridian Health · Phase 3, Interventional, and Treatment
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.
Many patients with multiple myeloma receive 2 stem cell transplantations within a few months of each other as part of their treatment. Usually the drug Melphalan is used for both transplants.
Bortezomib is a drug that is used for treating multiple myeloma and has been used in combination with melphalan for stem cell transplantation for patients with multiple myeloma.
The purpose of this trial is to study the effects of doing 2 transplants, first using melphalan and second using melphalan and bortezomib. The trial is aiming to find out if adding the Bortezomib to the second transplant will increase the chances of staying in remission longer.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 148 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Hackensack Meridian Health is the lead sponsor of 111 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 11 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma
Drug: Bortezomib
Bortezomib 1.6mg/m2 on day -4 and day -1
Also known as: Velcade
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.
Progression-free survival of participants that received tandem transplants on study
Time frame: 3 years
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.
Overall response rate of participants after completing tandem transplant. Overall Response rate defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria.
Time frame: 3 years
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.
Survival rate of participants after completion of tandem transplant
Time frame: 3 years
| Milestone | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| Started | 148 |
| Completed | 92 |
| Not completed | 56 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Screen failure | 6 |
| Withdrew: Did not move forward with 2nd transplant | 39 |
| Withdrew: Lost to follow-up | 5 |
Progression-free survival of participants that received tandem transplants on study
| Percent | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| 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 (64.3 to 82.2) |
Overall response rate of participants after completing tandem transplant. Overall Response rate defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria.
| Participants | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| 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 |
Survival rate of participants after completion of tandem transplant
| Participants | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| 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 |
Collected over All-Cause Mortality was assessed for up to 3 years. Serious Adverse Events were assessed up to 100 days after bone marrow transplant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tandem Transplantation With Melphalan and Bortezomib | 46/142 (32.4%) | 67/142 (47.2%) | — |
| Event | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| Disease ProgressionInvestigations | 26/142 |
| InfectionInfections and infestations | 15/142 |
| Engraftment SyndromeImmune system disorders | 4/142 |
| RashSkin and subcutaneous tissue disorders | 4/142 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 3/142 |
| FeverInvestigations | 3/142 |
| Failure to ThriveInvestigations | 2/142 |
| DiarrheaGastrointestinal disorders | 2/142 |
| RSVInfections and infestations | 1/142 |
| NauseaGastrointestinal disorders | 1/142 |
| Age, Categorical(Participants) | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 126 |
| >=65 years | 16 |
| Age, Continuous(years) | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| Mean | 56.4 (32.4 to 72.8) |
| Sex: Female, Male(Participants) | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| Female | 52 |
| Male | 90 |
| Ethnicity (NIH/OMB)(Participants) | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| Hispanic or Latino | 15 |
| Not Hispanic or Latino | 123 |
| Unknown or Not Reported | 4 |
| Race (NIH/OMB)(Participants) | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 13 |
| White | 108 |
| More than one race | 0 |
| Unknown or Not Reported | 12 |
| Region of Enrollment(participants) | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| United States | 142 |
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Hackensack Meridian Health