QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01670994
Recruitment Status : Terminated (Patient population did not benefit from single agent treatment.)
First Posted : August 23, 2012
Last Update Posted : October 28, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Altor BioScience

Brief 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.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma
Study Start Date : August 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety Profile [ Time Frame: 7 weeks ]

    For phase Ib & II

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

  2. Tolerability and MTD designation [ Time Frame: 7 weeks ]

    For phase Ib only

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

Secondary Outcome Measures :
  1. Clinical Benefit [ Time Frame: 12 weeks ]

    For phase Ib and II

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

  2. Immunogenicity and Pharmacokinetics [ Time Frame: 8 weeks ]

    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

  3. Tumor Typing [ Time Frame: 1 month ]

    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

  4. Overall and progression-free survival [ Time Frame: 3 years ]

    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

  5. Duration of Response [ Time Frame: up to 3 years ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No



  • 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


  • No anti-myeloma treatments within 28 days before the start of study treatment.
  • Must have recovered from side effects of prior treatments.



• ≥ 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)


  • 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


• Normal clinical assessment of pulmonary function


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01670994

United States, Iowa
University of Iowa Hospitals
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Altor BioScience
National Cancer Institute (NCI)
Study Chair: Hing C Wong, PhD Altor BioScience

Responsible Party: Altor BioScience Identifier: NCT01670994     History of Changes
Other Study ID Numbers: CA-ALT-801-01-11
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Altor BioScience:
T-cell receptor
p53 gene
p53 tumor supressor protein
HLA-A2 positive
HLA-A*0201/p53 aa264-272
HLA complex
multiple myeloma
IFN-γ and TNF-α

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs