Clinical trial · Interventional
BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma
A Phase I Study to Assess The Safety and Pharmacokinetics of BB-10901 (huN901-DM1) Given as an Intravenous Infusion Weekly for Two Consecutive Weeks Every Three Weeks to Subjects With Relapsed and Relapsed Refractory CD56-Positive Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as BB-10901, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed and/or refractory multiple myeloma.
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 |
|---|---|---|---|
| BB-10901 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Dose-limiting toxicity
- timeFrame
- through cycle 1
- measure
- Maximum tolerated dose
- timeFrame
- for the duration of the study
Secondary outcomes (3)
- measure
- Qualitative and quantitative toxicities
- timeFrame
- for the duration of the study
- measure
- Pharmacokinetics
- timeFrame
- for the duration of the study
- measure
- Anti-tumor activity including overall response rate, time to progression and survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma * Relapsed or relapsed/refractory disease * Failed ≥ 1 prior therapy for multiple myeloma * Once the MTD is defined, only patients who have received at least 1 but equal or less than 6 prior chemotherapy regimens will be enrolled at this dose level * CD56-positive disease confirmed by immunohistochemistry or flow cytometry PATIENT CHARACTERISTICS: * ECOG (Zubrod) performance status 0-2 * Life expectancy ≥ 12 weeks * Platelet count ≥ 75,000/mm\^3 * Absolute neutrophil count \> 1,000/mm\^3 * Hemoglobin ≥ 8.5 g/dL * AST and ALT ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Amylase and lipase within normal limits * Creatinine ≤ 2 mg/dL * Left ventricular ejection fraction ≥ lower limit of normal on MUGA or ECHO * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No peripheral neuropathy ≥ grade 3 or painful grade 2 neuropathy * No significant cardiac disease, including any of the following: * Myocardial infarction within the past 6 months * Unstable angina * Uncontrolled congestive heart failure * Uncontrolled hypertension (i.e., recurrent or persistent increases in systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg) * Uncontrolled cardiac arrhythmias * Cardiac toxicity ≥ grade 3 after prior chemotherapy * No history of multiple sclerosis or other demyelinating disease * No hemorrhagic or ischemic stroke within the past 6 months * No Eaton-Lambert syndrome (para-neoplastic syndrome) * No CNS injury with residual neurological deficit (other than peripheral neuropathy ≤ grade 2) * No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer * No clinically relevant active infection, including active hepatitis B or C infection or HIV infection * No other condition or disease, including laboratory abnormalities, that, in the opinion of the investigator, may preclude study treatment * No known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) * At least 4 weeks since prior radiotherapy * At least 4 weeks since prior major surgery (except placement of a vascular access device or tumor biopsies) * More than 4 weeks since prior investigational agents * At least 2 weeks since prior antineoplastic therapy with biological agents * No prior hypersensitivity to monoclonal antibody therapy * No other concurrent investigational agents * No concurrent corticosteroids (except as indicated for other medical conditions \[\< 10 mg prednisone or equivalent\]; as pre-medication for administration of certain medications or blood products \[≤ 100 mg hydrocortisone\]; or for treatment of infusion reactions) * Concurrent topical steroids allowed * No other concurrent antineoplastic treatment (e.g., chemotherapy, radiotherapy, or biological agents) * Concurrent bisphosphonates allowed provided patient began bisphosphonates before study entry and is maintained on a stable dose during study treatment
References
Publications (0)
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