NCT00675428 · REGISTRY CONDITION SEARCH

Study of Natalizumab in Relapsed/Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2014-09-19

The primary objectives of the study are to evaluate the safety profile and the anti-tumor activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple myeloma. Secondary objectives are to assess the pharmacokinetic (PK) profile of natalizumab in this study population and to assess peripheral blood mononuclear cell (PBMC) saturation of very late antigen-4 (VLA-4, an α4-integrin) and evaluate possible correlations with clinical activity.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose Limiting Toxicities (DLTs)

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Number of Participants With Adverse Events (AEs)

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outcome · POSTED

Number Of Participants Who Achieve A Complete Response

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outcome · POSTED

Kaplan-Meier Estimates for Duration Of Response For Participants With A Response

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outcome · POSTED

Pharmacokinetic (PK) Profile Of Natalizumab

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outcome · POSTED

Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Key Inclusion Criteria: * Relapsed or refractory multiple myeloma that was treated with or was considered inappropriate for treatment with bortezomib and an IMiD® drug (including an analogue). * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2. * Corrected calcium \<10.6 mg/dL. Key Exclusion Criteria: * Candidates for stem cell transplantation willing to undergo transplantation. (Subjects who are candidates for stem cell transplantation, but are not willing to undergo transplant will be eligible for the study.) * Autologous stem cell transplantation \<3 months post-transplant. * Prior allogeneic stem cell transplantation. * Nonsecretory myeloma. * Plasma cell leukemia (\>2000/µL circulating plasma cells by standard cell counting differential), hyperleukocytosis (white blood cells \>100,000/µL), clinical evidence of hyperviscosity syndrome, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), or primary systemic amyloidosis. * Subjects who cannot undergo a brain magnetic resonance imaging (MRI) study. * Clinically significant (as determined by the Investigator) 12 lead electrocardiogram (ECG) abnormalities, including QTc prolongation (\>450 ms in males, \>470 ms in females). NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
intervention Names
Drug: BG00002 (natalizumab)
label
Natalizumab 300 mg
type
EXPERIMENTAL
description
Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
intervention Names
Drug: BG00002 (natalizumab)
label
Natalizumab 450 mg
type
EXPERIMENTAL

interventions

arm Group Labels
Natalizumab 300 mg
Natalizumab 450 mg
name
BG00002 (natalizumab)
other Names
Tysabri
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 6
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants With Dose Limiting Toxicities (DLTs)
time Frame
Day 1 up to Day 28
description
Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006).
measure
Objective Response Rate (ORR)
time Frame
Day 1 up to Month 6
description
An 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.
measure
Number of Participants With Adverse Events (AEs)
time Frame
Day 1 up to Month 6

secondary Outcomes

description
Response 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.
measure
Number Of Participants Who Achieve A Complete Response
time Frame
Day 1 up to Month 6
description
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.
measure
Kaplan-Meier Estimates for Duration Of Response For Participants With A Response
time Frame
Day 1 up to Month 6
description
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).
measure
Pharmacokinetic (PK) Profile Of Natalizumab
time Frame
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)
measure
Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC)
time Frame
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.

Full study description

brief Summary: The primary objectives of the study are to evaluate the safety profile and the anti-tumor activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple myeloma. Secondary objectives are to assess the pharmacokinetic (PK) profile of natalizumab in this study population and to assess peripheral blood mononuclear cell (PBMC) saturation of very late antigen-4 (VLA-4, an α4-integrin) and evaluate possible correlations with clinical activity.
detailed Description: Despite no protocol-defined study stopping criteria being met, the sponsor decided to terminate enrollment after the phase 1 portion was complete and to not move into the phase 2 portion of the study. This decision was made due to difficulty enrolling participants and was not due to any safety concerns.

Source references

Source notices and limitations

Discovery and provenance

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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice