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QUILT-3.005: A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02099539
Recruitment Status : Active, not recruiting
First Posted : March 31, 2014
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Altor BioScience

Brief Summary:
This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of ALT-803 in patients with relapsed or refractory multiple myeloma.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Biological: ALT-803 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : October 2014
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: ALT-803 Biological: ALT-803
Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles




Primary Outcome Measures :
  1. Safety Profile [ Time Frame: 24 months ]

    For phase I & II

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


  2. MTD or MED Determination, Phase II Dose Level Designation [ Time Frame: 9 months ]

    For phase I only

    Determine the maximum tolerated dose (MTD) level or minimum efficacious dose (MED) and designate the dose level for phase II.



Secondary Outcome Measures :
  1. Clinical Benefit [ Time Frame: 24 months ]

    For phase I and II

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


  2. Blood Cell Counts [ Time Frame: 24 months ]

    For phase Ib and II

    Evaluation of the effect of ALT-803 on the peripheral ALC and WBC counts, the number and phenotype of peripheral blood T (total and subsets) and NK cells in treated patients.


  3. Pharmacokinetics [ Time Frame: 24 months ]

    For phase I and II

    Area under the plasma concentration-time curve from time zero to infinity (AUC) and the half-life of ALT-803.


  4. Biomarkers [ Time Frame: 24 months ]

    For phase I and II

    Measures the serum levels of IL-2, IL-4, IL-6, IL-10, IFN-gamma, MCP-1 and TNF-alpha in treated patients.


  5. Immunogenicity [ Time Frame: 24 months ]

    For Phase I and II

    Measures the anti-ALT-803 neutralizing effects.


  6. Overall Survival [ Time Frame: 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 overall survival, progression-free survival and duration of response.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 14 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) > 40mL/min or Serum creatinine ≤ 1.5 X ULN

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 on-going chronic systemic corticosteroid (>10 mg daily prednisone equivalent) use or other immunosuppressive therapy (a history of mild asthma not requiring therapy is eligible). Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

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 ClinicalTrials.gov identifier (NCT number): NCT02099539


Locations
United States, Minnesota
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Altor BioScience
National Cancer Institute (NCI)
Investigators
Study Chair: Hing C Wong, PhD Altor BioScience

Responsible Party: Altor BioScience
ClinicalTrials.gov Identifier: NCT02099539     History of Changes
Other Study ID Numbers: CA-ALT-803-02-13
CA167925 ( Other Identifier: NIH )
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Altor BioScience:
absolute lymphocyte count
antitumor
cancer
immunotherapy
immunochemotherapy
interleukin-15
multiple myeloma
NK cell
refractory
relapsed
T cell
white blood cell count

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