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 States, Argentina37 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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.