QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma (NCT01670994) | Clinical Trial Compass
TerminatedPhase 1/2
QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma
Stopped: Patient population did not benefit from single agent treatment.
United States6 participantsStarted 2012-08-14
Plain-language summary
This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 in patients who have relapsed 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.
ENTRY CRITERIA:
DISEASE CHARATERISTICS:
* Confirmed diagnosis of relapsed/refractory multiple myeloma after treatment with at least two different previous regimens.
* Refractory disease is defined as progressive disease while on therapy or progression within 60 days of therapy.
* Progressive disease is defined by a 25% increase from the lowest response value in specified tests.
* Measurable disease as defined by at least one of the following:
* Serum M-protein ≥ 1g/dL (for IgG, IgM) or 0.5 g/dL (for IgA)
* Urine M-protein ≥ 200mg/24hours
* Serum free light chains ≥ 10 mg/dL and abnormal kappa/lambda ratio
PRIOR/CONCURRENT THERAPY:
* No anti-myeloma treatments within 28 days before the start of study treatment.
* Must have recovered from side effects of prior treatments.
PATIENT CHARACTERISTICS:
Age
• ≥ 18 years
Performance Status
• ECOG 0, 1, or 2
Bone Marrow Reserve
* Absolute neutrophil count (AGC/ANC) ≥ 1,000/uL
* Platelets ≥ 30,000/uL
* Hemoglobin ≥ 8g/dL
Renal Function
• Glomerular Filtration Rate (GFR) \> 45mL/min/1.73m\^2
Hepatic Function
* Total bilirubin ≤ 2.0 X ULN
* AST, ALT, ALP ≤ 3.0 X ULN, or ≤ 5.0 X ULN (if liver metastases exist)
Cardiovascular
* No congestive heart failure \< 6 months
* No unstable angina pectoris \< 6 months
* No myocardial infarction \< 6 months
* No history of ventricular arrhythmias
* No history of supraventricular arrhythmias
* No NYHA Class \> II CHF
* Normal Transthoracic Echocardiogram (TTE) is required fo…
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.
What they're measuring
1
Number of Participants With Treatment-Related Adverse Events