A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma
Conditions
Relapsed or Refractory Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
absolute lymphocyte count, antitumor, cancer, immunotherapy, immunochemotherapy, interleukin-15, multiple myeloma, NK cell, refractory, relapsed, T cell, white blood cell count
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ALT-803
Type: Biological
Overall Status
Recruiting
Summary
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose escalation study of ALT-803 in patients with relapsed or refractory multiple myeloma.
Detailed Description
The purpose of this study is to evaluate the safety, determine the Maximum Tolerated Dose (MTD) or the Minimum Efficacious Dose (MED) and characterize the immunogenicity and pharmacokinetic profile of ALT-803 in treated patients. The effect of ALT-803 on the peripheral absolute lymphocyte counts and white blood cell counts, the number and phenotype of peripheral blood T (total and subsets) and NK cells will be evaluated. The anti-tumor responses of ALT-803 will also be assessed in this trial.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: ENTRY CRITERIA:

DISEASE CHARACTERISTICS:

- 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:

Performance Status

• ECOG 0, 1, or 2

Bone Marrow Reserve

- Absolute neutrophil count (AGC/ANC) ≥ 1000/uL

- Platelets ≥ 30,000/uL

- Hemoglobin ≥ 8g/dL

- Absolute lymphocytes ≥ 800/uL

- Leukocytes ≥ 3,000/uL

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)

- No positive Hep C serology or active Hep B infection

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

- No marked baseline prolongation of QT/QTc interval

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

- No active systemic infection requiring parenteral antibiotic therapy

- No ongoing chronic systemic steroid therapy or regular inhaled cortocosteroid use
Locations
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Dixie Lewis, RN, BA - 612-624-4601 - lewis029@umn.edu
Washington University School of Medicine
St. Louis, Missouri, United States
Status: Recruiting
Contact: Charles Powell - 314-747-2740 - cpowell@DOM.wustl.edu
Roswell Park Cancer Institute
Buffalo, New York, United States
Status: Recruiting
Contact: Colleen Borsuk, BSN, RN - 716-845-1657 - Colleen.Borsuk@RoswellPark.org
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Briana Shields, RN, BSN - 215-955-9675 - Briana.Shields@jefferson.edu
Start Date
September 2014
Completion Date
January 2020
Sponsors
Altor Bioscience Corporation
Source
Altor Bioscience Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page