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Relapsed or Refractory Multiple MyelomaPhase 1NCT02099539

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

A Phase 1 study testing N-803 in people with Relapsed or Refractory Multiple Myeloma, run by Altor BioScience at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
N-803
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
4 sitesUnited States
Study dates
6 Oct 2014to 19 Jun 2018
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Minnesota Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I/II Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma

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.

Read the 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.

Being tested
N-803
Keywords
absolute lymphocyte count, antitumor, cancer, immunotherapy, immunochemotherapy, interleukin-15, multiple myeloma, NK cell, refractory, relapsed, T cell, white blood cell count
Medical subject headings
Recurrence, Multiple Myeloma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-803Biological

    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

Study groups in NCT02099539
Study groupRoleWhat they receive
Cohort 1: N-803 - IV 1 ug/kgExperimentalNot described
Receives: Biological: N-803
Cohort 2: N-803 - IV 3 ug/kgExperimentalNot described
Receives: Biological: N-803
Cohort 3: N-803 - IV 6 ug/kgExperimentalNot described
Receives: Biological: N-803
Cohort 4: N-803 - IV 10 ug/kgExperimentalNot described
Receives: Biological: N-803
Cohort 5: N-803 - SQ 10 ug/kgExperimentalNot described
Receives: Biological: N-803
Cohort 6: N-803 - SQ 15 ug/kgExperimentalNot described
Receives: Biological: N-803

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Events

    For phase I - Number of Participants with Treatment Emergent Adverse Events that occur or worsen after the first dose of study treatment.

    Measured: 24 weeks

  2. Disease Response Rate of Treated Patients

    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

    Measured: Starts at Week 11 - 12 and Week 23 - 24

Secondary outcomes (9)

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

    Half-life (t½) - The period of time required for the concentration or amount of drug in the body to be reduced by one-half.

    Measured: PK timepoint up to 72 hours +/- 6 hours

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

    time of the observed maximum concentration (Tmax)

    Measured: PK timepoint up to 72 hours +/- 6 hours

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

    maximum observed concentration (Cmax)

    Measured: PK timepoint up to 72 hours +/- 6 hours

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

    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.

    Measured: 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. Characterization of the Pharmacokinetic Profile - Clearance (CL)

    Clearance (CL)

    Measured: PK timepoint up to 72 hours +/- 6 hours

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

    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

    Measured: PK timepoint up to 72 hours +/- 6 hours

  7. Immunogenicity - Anti-drug Antibody (ADA)

    Number of patients with a positive Anti-drug Antibody (ADA) result

    Measured: From Baseline up to Week 12

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

    Apparent (Extravascular) Clearance (CL/F)

    Measured: PK timepoint up to 72 hours +/- 6 hours

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

    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

    Measured: PK timepoint up to 72 hours +/- 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2014 (estimated)
  2. Study start6 Oct 2014
  3. Primary completion19 Jun 2018
  4. Study completion19 Jun 2018

Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02099539
Sponsor's protocol ID
CA-ALT-803-02-13
Other IDs
CA167925
Status last verified
Jan 2018
First submitted
26 Feb 2014
Last updated
26 Sep 2024
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing N-803 in people with Relapsed or Refractory Multiple Myeloma, run by Altor BioScience at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02099539.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.

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