Trial Outcomes & Findings for Doxil® + Melphalan + Velcade (DMV) in Relapsed/Refractory Multiple Myeloma (NCT NCT00985907)
NCT ID: NCT00985907
Last Updated: 2020-06-17
Results Overview
Safety assessments will be evaluated as the proportion of patients experiencing the following: treatment-related grade 3 or higher toxicity (hematologic and nonhematologic) and treatment-related death.
TERMINATED
PHASE1/PHASE2
13 participants
Up to 2 cycles of treatment, approximately 56 days
2020-06-17
Participant Flow
Arms/Groups are not separated by individual cohorts within Phase 1 as information was lost when it was transferred from our legacy system. Paper records were lost in a flood, so participants were only grouped electronically by which phase they were enrolled. The study was terminated and participants were not enrolled in Phase 2 part of the study.
Participant milestones
| Measure |
Phase 1
Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d
Melphalan: IV over 30 min, Day 1 q28d
Velcade®: IV bolus, Day 1, 4, 8, 11 q28d
Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2
Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Doxil® + Melphalan + Velcade (DMV) in Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Doxil® + Melphalan + Velcade (DMV)
n=13 Participants
Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d
Melphalan: IV over 30 min, Day 1 q28d
Velcade®: IV bolus, Day 1, 4, 8, 11 q28d
Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2
Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2
|
|---|---|
|
Age, Customized
30-39 years old
|
1 Participants
n=5 Participants
|
|
Age, Customized
40-49 years old
|
1 Participants
n=5 Participants
|
|
Age, Customized
50-59 years old
|
6 Participants
n=5 Participants
|
|
Age, Customized
60-69 years old
|
3 Participants
n=5 Participants
|
|
Age, Customized
70-79 years old
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 cycles of treatment, approximately 56 daysPopulation: Only data for Phase 1, Cohort 1 DLT was collected
Safety assessments will be evaluated as the proportion of patients experiencing the following: treatment-related grade 3 or higher toxicity (hematologic and nonhematologic) and treatment-related death.
Outcome measures
| Measure |
Doxil® + Melphalan + Velcade (DMV)
n=4 Participants
Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d
Melphalan: IV over 30 min, Day 1 q28d
Velcade®: IV bolus, Day 1, 4, 8, 11 q28d
Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2
Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2
|
|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT) (Phase 1)
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Data not collected
The MTD will be considered the dose below where \<= 3 patients experience a DLT and the dose that two cycles can be given without meeting toxicity criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: Data not collected
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 will be used to determine all treatment related toxicities at the MTD. Participants entered at the MTD Dose level from the phase I portion of the study will also be included in this analysis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Data not collected
At each cycle, participants will be assessed for treatment response: Complete Response (CR), Near CR(nCR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD), or Progressive Disease (PD) on at least 2 measurements at minimum of a 4 week interval. The overall response rate will use the best response of CR, nCR, PR, MR, or SD. In order to qualify for responses, the following events may NOT have occurred - new/increased size of plasmacytomas or bone lesions, recurrence or persistence of hypercalcemia. Collapse of bony structure from previous disease will not constitute progression or failure to respond. Participants entered at the MTD Dose level from the phase I portion of the study will also be included in this analysis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: Data not collected
Efficacy of DMV as determined by time to first observed response. Participants entered at the MTD Dose level from the phase I portion of the study will also be included in this analysis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Data not collected
Efficacy of DMV as determined by progression free survival. Participants entered at the MTD Dose level from the phase I portion of the study will also be included in this analysis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Data not collected
Overall survival is defined as the amount of time from start of study therapy until death, or study completion. Participants entered at the MTD Dose level from the phase I portion of the study will also be included in this analysis
Outcome measures
Outcome data not reported
Adverse Events
Phase 1 Doxil® + Melphalan + Velcade (DMV)
Serious adverse events
| Measure |
Phase 1 Doxil® + Melphalan + Velcade (DMV)
n=13 participants at risk
Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d
Melphalan: IV over 30 min, Day 1 q28d
Velcade®: IV bolus, Day 1, 4, 8, 11 q28d
Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2
Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2
|
|---|---|
|
Investigations
Hyperbilirubinemia
|
7.7%
1/13 • Number of events 1 • Up to 5 years
Arms are not separated by individual cohorts within Phase 1 as information was lost when it was transferred from legacy system. When legacy patient data was transferred, it was decided that only mortality and serious adverse event data should be retained and transferred. Other adverse event (AE) data was not electronically transferred. Paper records were lost in a flood, so participants AE data could not be recovered. The study was terminated and participants not enrolled in Phase 2.
|
|
Infections and infestations
Infection
|
7.7%
1/13 • Number of events 1 • Up to 5 years
Arms are not separated by individual cohorts within Phase 1 as information was lost when it was transferred from legacy system. When legacy patient data was transferred, it was decided that only mortality and serious adverse event data should be retained and transferred. Other adverse event (AE) data was not electronically transferred. Paper records were lost in a flood, so participants AE data could not be recovered. The study was terminated and participants not enrolled in Phase 2.
|
|
Nervous system disorders
Neurological disorder NOS
|
7.7%
1/13 • Number of events 1 • Up to 5 years
Arms are not separated by individual cohorts within Phase 1 as information was lost when it was transferred from legacy system. When legacy patient data was transferred, it was decided that only mortality and serious adverse event data should be retained and transferred. Other adverse event (AE) data was not electronically transferred. Paper records were lost in a flood, so participants AE data could not be recovered. The study was terminated and participants not enrolled in Phase 2.
|
|
Hepatobiliary disorders
Cholecystitis
|
7.7%
1/13 • Number of events 1 • Up to 5 years
Arms are not separated by individual cohorts within Phase 1 as information was lost when it was transferred from legacy system. When legacy patient data was transferred, it was decided that only mortality and serious adverse event data should be retained and transferred. Other adverse event (AE) data was not electronically transferred. Paper records were lost in a flood, so participants AE data could not be recovered. The study was terminated and participants not enrolled in Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Bone Fracture
|
7.7%
1/13 • Number of events 1 • Up to 5 years
Arms are not separated by individual cohorts within Phase 1 as information was lost when it was transferred from legacy system. When legacy patient data was transferred, it was decided that only mortality and serious adverse event data should be retained and transferred. Other adverse event (AE) data was not electronically transferred. Paper records were lost in a flood, so participants AE data could not be recovered. The study was terminated and participants not enrolled in Phase 2.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • Up to 5 years
Arms are not separated by individual cohorts within Phase 1 as information was lost when it was transferred from legacy system. When legacy patient data was transferred, it was decided that only mortality and serious adverse event data should be retained and transferred. Other adverse event (AE) data was not electronically transferred. Paper records were lost in a flood, so participants AE data could not be recovered. The study was terminated and participants not enrolled in Phase 2.
|
|
Vascular disorders
Thrombosis
|
7.7%
1/13 • Number of events 1 • Up to 5 years
Arms are not separated by individual cohorts within Phase 1 as information was lost when it was transferred from legacy system. When legacy patient data was transferred, it was decided that only mortality and serious adverse event data should be retained and transferred. Other adverse event (AE) data was not electronically transferred. Paper records were lost in a flood, so participants AE data could not be recovered. The study was terminated and participants not enrolled in Phase 2.
|
|
Infections and infestations
Lung Infection
|
7.7%
1/13 • Number of events 1 • Up to 5 years
Arms are not separated by individual cohorts within Phase 1 as information was lost when it was transferred from legacy system. When legacy patient data was transferred, it was decided that only mortality and serious adverse event data should be retained and transferred. Other adverse event (AE) data was not electronically transferred. Paper records were lost in a flood, so participants AE data could not be recovered. The study was terminated and participants not enrolled in Phase 2.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Thomas Martin, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place