Trial Outcomes & Findings for Study of Natalizumab in Relapsed/Refractory Multiple Myeloma (NCT NCT00675428)
NCT ID: NCT00675428
Last Updated: 2014-09-19
Results Overview
DLTs = any ≥grade 3 toxicity related to treatment; treatment delays of ≥7 days due to any toxicity related to treatment, with the exception of hepatic transaminases; or alanine and/or aspartate aminotransferase (ALT and/or AST) \>3\*upper limit of normal (ULN) with either a total bilirubin \>2\*ULN or an international normalized ratio (INR) \>1.5 related to treatment, or with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia.
TERMINATED
PHASE1/PHASE2
6 participants
Day 1 up to Day 28
2014-09-19
Participant Flow
This record includes data up to and including the last data values collected during long-term follow-up (27 January 2010).
Participant milestones
| Measure |
Natalizumab 300 mg
Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
|
Natalizumab 450 mg
Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Natalizumab 300 mg
Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
|
Natalizumab 450 mg
Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
|
|---|---|---|
|
Overall Study
Disease Progression
|
2
|
2
|
|
Overall Study
No Disease Response After Cycle 6
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Study of Natalizumab in Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Natalizumab 300 mg
n=3 Participants
Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
|
Natalizumab 450 mg
n=3 Participants
Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
n=5 Participants
|
68.0 years
n=7 Participants
|
67.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 28DLTs = any ≥grade 3 toxicity related to treatment; treatment delays of ≥7 days due to any toxicity related to treatment, with the exception of hepatic transaminases; or alanine and/or aspartate aminotransferase (ALT and/or AST) \>3\*upper limit of normal (ULN) with either a total bilirubin \>2\*ULN or an international normalized ratio (INR) \>1.5 related to treatment, or with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia.
Outcome measures
| Measure |
Natalizumab 300 mg
n=3 Participants
Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
|
Natalizumab 450 mg
n=3 Participants
Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 1 up to Month 6Population: ORR was not calculated because the study was terminated early.
Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 up to Month 6An AE was defined as any untoward medical occurrence in a participant administered medicinal (investigational) product and that does not necessarily have a causal relationship with this product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. See the adverse events section of the record for more details.
Outcome measures
| Measure |
Natalizumab 300 mg
n=3 Participants
Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
|
Natalizumab 450 mg
n=3 Participants
Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Month 6Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Complete Response (CR): negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas , and ≤ 5% plasma cells in the bone marrow. Stringent CR (sCR): CR as defined above, and normal free light chain (FLC) ratio, and absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence, based on a κ/λ ratio of \> 4:1 or \< 1:2 performed on a minimum of 100 plasma cells.
Outcome measures
| Measure |
Natalizumab 300 mg
n=3 Participants
Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
|
Natalizumab 450 mg
n=3 Participants
Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
|
|---|---|---|
|
Number Of Participants Who Achieve A Complete Response
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Month 6Population: Duration of response was not calculated because the study was terminated early.
Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Kaplan-Meier methods were used to estimate the median duration of response and associated 95% confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 6: Day 1 (before infusion and 0.25, 2, 6 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: Day 1 (before infusion and 0.25 hour after infusion)Population: PK analysis was not performed because the study was terminated early.
PK modeling, either compartmental or noncompartmental-based, was used to describe serum concentrations. Standard PK parameters estimated include: area-under-the-concentration-time curve (AUC), maximum-observed concentration (Cmax), time-to-reach maximum concentration (Tmax), total body clearance (Cl), volume of distribution (Vd), and elimination half-life (t1/2).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Day 1 (1 hour before infusion and 1 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: 1 hour before and 1 hour after infusion). Cycle 6: Day 1 (1 hour before infusion and 1 hour after infusion), Days 8, 15, 22.Population: Analysis of binding saturation of α4 integrin sites was not performed because the study was terminated early.
Outcome measures
Outcome data not reported
Adverse Events
Natalizumab 300 mg
Natalizumab 450 mg
Serious adverse events
| Measure |
Natalizumab 300 mg
n=3 participants at risk
Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
|
Natalizumab 450 mg
n=3 participants at risk
Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
Other adverse events
| Measure |
Natalizumab 300 mg
n=3 participants at risk
Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
|
Natalizumab 450 mg
n=3 participants at risk
Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Infections and infestations
Respiratory Tract Infection
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Psychiatric disorders
Confusional State
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
General disorders
Fatigue
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Investigations
Blood Creatinine Increased
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
33.3%
1/3 • 463 days (from date of first treatment on 4 September 2008 until the Last Patient Last Visit on 10 December 2009).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER