Auto Stem Cell Transplant, Multiple Myeloma
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGBortezomib
Bortezomib 1.6mg/m2 on day -4 and day -1
Sponsors
Hackensack Meridian Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 years | Progression-free survival of participants that received tandem transplants on study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 years | 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. |
| 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. | 3 years | Survival rate of participants after completion of tandem transplant |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tandem Transplantation With Melphalan and Bortezomib Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma
Bortezomib: Bortezomib 1.6mg/m2 on day -4 and day -1 | 142 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not move forward with 2nd Transplant | 39 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Screen Failure | 6 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Tandem Transplantation With Melphalan and Bortezomib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 126 Participants |
| Age, Continuous | 56.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 108 Participants |
| Region of Enrollment United States | 142 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 46 / 142 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 67 / 142 |
Outcome results
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.
Progression-free survival of participants that received tandem transplants on study
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 Percent |
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.
Survival rate of participants after completion of tandem transplant
Time frame: 3 years
Population: 94 participant survival assessed after completion of tandem transplant
| Arm | Measure | Value (COUNT_OF_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 Participants |
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.
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
Population: 94 participant response assessed after completion of tandem transplant
| Arm | Measure | Value (COUNT_OF_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 Participants |