Relapsed or Refractory Multiple Myeloma Clinical Trial
Official title:
A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma
Verified date | October 2016 |
Source | Altor Bioscience Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | September 2015 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 for patients with history of EKG abnormalities, CHF, coronary artery disease or other cardiac disease, or with a history of having received adriamycin or doxorubicin - Patients with a left ventricular ejection fraction (LVEF) of less than 50% will be excluded from study entry Pulmonary • Normal clinical assessment of pulmonary function Other - Negative serum pregnancy test if female and of childbearing potential - Women who are not pregnant or nursing - Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study - No known autoimmune disease other than corrected hypothyroidism - No known prior organ allograft or allogeneic transplantation - Not HIV positive - No history or evidence of uncontrollable CNS disease - No psychiatric illness/social situation - No other illness that in the opinion of the investigator would exclude the subject from participating in the study - Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations - Active systemic infection requiring parenteral antibiotic therapy. - No ongoing chronic systemic steroid therapy required. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Altor Bioscience Corporation | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety Profile | For phase Ib & II Number and severity of treatment related AEs that occur or worsen after the first dose of study treatment |
7 weeks | Yes |
Primary | Tolerability and MTD designation | For phase Ib only To evaluate the tolerability and to determine the maximum tolerated dose (MTD) level. |
7 weeks | Yes |
Secondary | Clinical Benefit | For phase Ib and II Number of participants with an objective response, which includes, a complete response, a partial response or a stable disease |
12 weeks | No |
Secondary | Immunogenicity and Pharmacokinetics | For phase Ib and II Measures the anti-ALT-801 and IL-2 neutralizing effects Area under the plasma concentration-time curve from time zero to infinity (AUC) and the half-life of ALT-801 |
8 weeks | No |
Secondary | Tumor Typing | For phase Ib and II To assess the relationship between tumor presentation of HLA-A*0201/p53 aa 264-272 complex and the safety, immune response and clinical benefit of study treatment |
1 month | No |
Secondary | Overall and progression-free survival | For phase Ib and II All enrolled patients will be assessed every 3 months during year 1 and then every 6 months during years 2 and 3 from the start of study treatment to determine their overall and progression-free survival |
3 years | No |
Secondary | Duration of Response | All enrolled patients will be assessed every 3 months during year 1 and then every 6 months during years 2 and 3 from the start of study treatment to determine their duration of response | up to 3 years | No |
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