A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Altor Bioscience Corporation
ClinicalTrials.gov Identifier:
NCT01670994
First received: August 20, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Relapsed or Refractory Multiple Myeloma
Biological: ALT-801
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Altor Bioscience Corporation:

Primary Outcome Measures:
  • Safety Profile [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

    For phase Ib & II

    Number and severity of treatment related AEs that occur or worsen after the first dose of study treatment


  • Tolerability and MTD designation [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

    For phase Ib only

    To evaluate the tolerability and to determine the maximum tolerated dose (MTD) level.



Secondary Outcome Measures:
  • Clinical Benefit [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    For phase Ib and II

    Number of participants with an objective response, which includes, a complete response, a partial response or a stable disease


  • Immunogenicity and Pharmacokinetics [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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


  • Tumor Typing [ Time Frame: 1 month ] [ Designated as safety issue: No ]

    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


  • Overall and progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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


  • Duration of Response [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 66
Study Start Date: August 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALT-801 Biological: ALT-801
Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
Other Name: c264scTCR-IL2

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670994

Locations
United States, Iowa
University of Iowa Hospitals
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Altor Bioscience Corporation
Investigators
Study Chair: Hing C Wong, PhD Altor Bioscience Corporation
  More Information

No publications provided

Responsible Party: Altor Bioscience Corporation
ClinicalTrials.gov Identifier: NCT01670994     History of Changes
Other Study ID Numbers: CA-ALT-801-01-11
Study First Received: August 20, 2012
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Altor Bioscience Corporation:
cancer
immunotherapy
immunochemotherapy
targeted
metastatic
interleukin-2
antitumor
TCR
T-cell receptor
p53
p53 gene
p53 tumor supressor protein
HLA-A2 positive
HLA-A*0201/p53 aa264-272
HLA complex
multiple myeloma
IFN-γ and TNF-α
refractory
relapsed

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014