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NCT02099539 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
TERMINATED
Registry last update
2024-09-26

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Treatment Emergent Adverse Events

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outcome · POSTED

Disease Response Rate of Treated Patients

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outcome · POSTED

Characterization of the Pharmacokinetic Profile - Half-life (t½)

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outcome · POSTED

Characterization of the Pharmacokinetic Profile - Time of the Observed Maximum Concentration (Tmax)

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outcome · POSTED

Characterization of the Pharmacokinetic Profile - Maximum Observed Concentration (Cmax)

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outcome · POSTED

Characterization of the Pharmacokinetic Profile - Area Under the Plasma Concentration Curve

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outcome · POSTED

Characterization of the Pharmacokinetic Profile - Clearance (CL)

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outcome · POSTED

Characterization of the Pharmacokinetic Profile - Vss Volume of Distribution at Steady State

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outcome · POSTED

Immunogenicity - Anti-drug Antibody (ADA)

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outcome · POSTED

Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Clearance (CL/F)

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outcome · POSTED

Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Volume of Distribution (Vz/F)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Biological: N-803
    label
    Cohort 1: N-803 - IV 1 ug/kg
    type
    EXPERIMENTAL
  2. intervention Names
    1. Biological: N-803
    label
    Cohort 2: N-803 - IV 3 ug/kg
    type
    EXPERIMENTAL
  3. intervention Names
    1. Biological: N-803
    label
    Cohort 3: N-803 - IV 6 ug/kg
    type
    EXPERIMENTAL
  4. intervention Names
    1. Biological: N-803
    label
    Cohort 4: N-803 - IV 10 ug/kg
    type
    EXPERIMENTAL
  5. intervention Names
    1. Biological: N-803
    label
    Cohort 5: N-803 - SQ 10 ug/kg
    type
    EXPERIMENTAL
  6. intervention Names
    1. Biological: N-803
    label
    Cohort 6: N-803 - SQ 15 ug/kg
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort 1: N-803 - IV 1 ug/kg
    2. Cohort 2: N-803 - IV 3 ug/kg
    3. Cohort 3: N-803 - IV 6 ug/kg
    4. Cohort 4: N-803 - IV 10 ug/kg
    5. Cohort 5: N-803 - SQ 10 ug/kg
    6. Cohort 6: N-803 - SQ 15 ug/kg
    description
    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
    name
    N-803
    type
    BIOLOGICAL
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
19
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    For phase I - Number of Participants with Treatment Emergent Adverse Events that occur or worsen after the first dose of study treatment.
    measure
    Number of Participants With Treatment Emergent Adverse Events
    time Frame
    24 weeks
  2. description
    CR- negative SIFE and UIFE, disappearance of any soft tissue plasmacytomas, and \< or = to 5% plasma cells in bone marrow VGPR - either + SIFE and UIFE and - SPEP and UPEP or reduction in serum M-protein \> or = to 90% and urine m-protein level \<100mg per 24h PR - if measurable serum an urine m-protein them reduction of serum m-protein by \>=50% and reduction in 24h urinary m protein by \>=90% or to \<200mg per 24h if unmeasurable serum and urine m-protein then \>= 50% decrease in the difference between involve and uninvolved FLC levels If unmeasurable serum and urine m-protein and serum FLC assay then \>= 50% reduction in plasma cells, provide baseline bone marrow plasma cell percentage was \>=30% In addition to the above listed criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required PD - defined via International Myeloma Working Group uniform response criteria: disease progression SD - not meeting criteria for CR, VGPR, PR or PD
    measure
    Disease Response Rate of Treated Patients
    time Frame
    Starts at Week 11 - 12 and Week 23 - 24
secondary Outcomes
  1. description
    Half-life (t½) - The period of time required for the concentration or amount of drug in the body to be reduced by one-half.
    measure
    Characterization of the Pharmacokinetic Profile - Half-life (t½)
    time Frame
    PK timepoint up to 72 hours +/- 6 hours
  2. description
    time of the observed maximum concentration (Tmax)
    measure
    Characterization of the Pharmacokinetic Profile - Time of the Observed Maximum Concentration (Tmax)
    time Frame
    PK timepoint up to 72 hours +/- 6 hours
  3. description
    maximum observed concentration (Cmax)
    measure
    Characterization of the Pharmacokinetic Profile - Maximum Observed Concentration (Cmax)
    time Frame
    PK timepoint up to 72 hours +/- 6 hours
  4. description
    Area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t). PK samples were obtained from the start of treatment until 72 hours. The AUC0-168 and AUC0-inf were calculated with noncompartmental pharmacokinetic analysis equations.
    measure
    Characterization of the Pharmacokinetic Profile - Area Under the Plasma Concentration Curve
    time Frame
    Samples were collected and the AUC was determined at 24 hours and at time t (last measurable concentration). The AUC was calculated for 168 hours and time to infinity.
  5. description
    Clearance (CL)
    measure
    Characterization of the Pharmacokinetic Profile - Clearance (CL)
    time Frame
    PK timepoint up to 72 hours +/- 6 hours
  6. description
    Vss Volume of distribution at steady state is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration
    measure
    Characterization of the Pharmacokinetic Profile - Vss Volume of Distribution at Steady State
    time Frame
    PK timepoint up to 72 hours +/- 6 hours
  7. description
    Number of patients with a positive Anti-drug Antibody (ADA) result
    measure
    Immunogenicity - Anti-drug Antibody (ADA)
    time Frame
    From Baseline up to Week 12
  8. description
    Apparent (Extravascular) Clearance (CL/F)
    measure
    Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Clearance (CL/F)
    time Frame
    PK timepoint up to 72 hours +/- 6 hours
  9. description
    Apparent volume of distribution is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration
    measure
    Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Volume of Distribution (Vz/F)
    time Frame
    PK timepoint up to 72 hours +/- 6 hours
Full study description
brief Summary
This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of N-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 N-803 in treated patients. The effect of N-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 N-803 will also be assessed in this trial.
Source references
Source notices and limitations
    Discovery and provenance
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice