Clinical trial · Interventional
Study of Natalizumab in Relapsed/Refractory Multiple Myeloma
A Phase 1/2, Two-Arm, Dose-Finding Study of Natalizumab for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision due to low enrollment and not safety concerns.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BG00002 (natalizumab) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Natalizumab 300 mg
- description
- Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
- interventionNames
- Drug: BG00002 (natalizumab)
- type
- EXPERIMENTAL
- label
- Natalizumab 450 mg
- description
- Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
- interventionNames
- Drug: BG00002 (natalizumab)
Primary outcomes (3)
- measure
- Number of Participants With Dose Limiting Toxicities (DLTs)
- timeFrame
- Day 1 up to Day 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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