Trial Outcomes & Findings for Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma (NCT NCT00135200)
NCT ID: NCT00135200
Last Updated: 2025-04-30
Results Overview
The primary objective is to determine of the rate of objective response (percentage of patients with an objective response) defined as sustained reduction of monoclonal proteins by more than 25% versus pre-Bexxar level. An objective response may be: Minimal Response (MR) - 25-49% reduction on the level of the serum monoclonal protein for at least 2 determinations. Partial Response (PR) - 50-89% reduction in the level of the serum monoclonal protein for at least 2 determinations. Complete Response (CR) - Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation.
COMPLETED
PHASE2
16 participants
3 months
2025-04-30
Participant Flow
Participant milestones
| Measure |
Bexxar Therapeutic
The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.
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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Bexxar Therapeutic
n=16 Participants
The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.
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|---|---|
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Age, Continuous
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56 years
n=99 Participants
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Sex: Female, Male
Female
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7 Participants
n=99 Participants
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Sex: Female, Male
Male
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9 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 3 monthsThe primary objective is to determine of the rate of objective response (percentage of patients with an objective response) defined as sustained reduction of monoclonal proteins by more than 25% versus pre-Bexxar level. An objective response may be: Minimal Response (MR) - 25-49% reduction on the level of the serum monoclonal protein for at least 2 determinations. Partial Response (PR) - 50-89% reduction in the level of the serum monoclonal protein for at least 2 determinations. Complete Response (CR) - Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation.
Outcome measures
| Measure |
Bexxar Therapeutic
n=16 Participants
The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.
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|---|---|
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Percentage of Patients With an Objective Response
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31 percentage of patients
Interval 11.0 to 59.0
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SECONDARY outcome
Timeframe: 6 monthsDetermine the rate of conversion to complete response (CR). CR requires all of the following: * Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR. * Less than 5% plasma cells in the bone marrow on at least 2 determinations. Repeat bone marrow is not required for patients with secretory myeloma who have sustained absence of monoclonal protein on immunofixation. * No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response). * Disappearance of all soft tissue plasmacytomas. * Patients in whom some, but not all the criteria for CR are fulfilled are classified as nCR or PR or VGPR (see below), providing the remaining criteria for nCR, VGPR, or PR are satisfied.
Outcome measures
| Measure |
Bexxar Therapeutic
n=16 Participants
The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.
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Number of Participants With Complete Response (CR)
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2 participants
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SECONDARY outcome
Timeframe: up to approximately 15 years after treatmentProgressive Disease (PD)-Free Interval (Duration of Response): measured, in a responder, from the date when a Complete Response, Complete Response, unconfirmed (CRu), or Partial Response (PR) is first noted to the first date at which progressive disease is observed. An ongoing PD-free interval occurs when there is a responder for whom progressive disease has not been noted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to approximately 15 years after treatmentDisease progression or death from Multiple Myeloma from start of study treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to approximately 15 years after treatmentOf patients who initially responded (completely or partially) to treatment, at what subsequent point (measured in months) did they have progression of disease or begin a different treatment
Outcome measures
Outcome data not reported
Adverse Events
Bexxar Therapeutic
Serious adverse events
| Measure |
Bexxar Therapeutic
n=16 participants at risk
The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.
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Infections and infestations
Infection with Normal Neutrophil Count
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6.2%
1/16 • Number of events 1
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Infections and infestations
Infection wtih Unknown Neutrophil Count
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6.2%
1/16 • Number of events 1
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Nervous system disorders
Neuropathy - Motor
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6.2%
1/16 • Number of events 1
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Other adverse events
| Measure |
Bexxar Therapeutic
n=16 participants at risk
The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.
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Blood and lymphatic system disorders
Hemoglobin
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18.8%
3/16 • Number of events 3
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Blood and lymphatic system disorders
Leukocytes (total WBC)
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43.8%
7/16 • Number of events 7
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Blood and lymphatic system disorders
Lymphopenia
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31.2%
5/16 • Number of events 5
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Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
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50.0%
8/16 • Number of events 10
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Blood and lymphatic system disorders
Platelets
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56.2%
9/16 • Number of events 12
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General disorders
Fatigue (asthenia, lethargy, malaise)
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18.8%
3/16 • Number of events 3
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Skin and subcutaneous tissue disorders
Rash/desquamation
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12.5%
2/16 • Number of events 4
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Gastrointestinal disorders
Diarrhea
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18.8%
3/16 • Number of events 3
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Gastrointestinal disorders
Flatulence
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6.2%
1/16 • Number of events 1
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Gastrointestinal disorders
Nausea
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12.5%
2/16 • Number of events 2
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Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
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12.5%
2/16 • Number of events 2
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Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
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12.5%
2/16 • Number of events 2
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General disorders
Pain - Other
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12.5%
2/16 • Number of events 2
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Respiratory, thoracic and mediastinal disorders
Cough
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18.8%
3/16 • Number of events 3
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Additional Information
Dr. Mark Kaminski, M.D.
University of Michigan Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place