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 range18 Years
SexALL
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…
What they're measuring
1
Number of Participants With Treatment-Related Adverse Events