BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma (NCT00346255) | Clinical Trial Compass
CompletedPhase 1
BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma
United States37 participantsStarted 2005-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 isc…