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Asymptomatic MyelomaPhase 1NCT02784483

Pilot Study Of Anti-Programmed Death Ligand-1 (Anti-PD-L1, Atezolizumab) In Asymptomatic Myeloma

A Phase 1 study testing Atezolizumab (1200mg via IV infusion) in people with Asymptomatic Myeloma, run by Yale University at 1 site 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

The purpose of this pilot study is to gain initial insights into the biologic and clinical effects of Atezolizumab in patients with Asymptomatic Multiple Myeloma (AMM). The data may provide novel insights into anti-PDL-1-induced immunologic changes, which could potentially be relevant to its future development in… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Asymptomatic Myeloma
What is being tested?
Atezolizumab (1200mg via IV infusion)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
10 Feb 2017to 22 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet the following criteria for study entry:
  • All patients must sign an Informed Consent Form (ICF) approved by Institutional Review Board, and express ability and willingness to comply with the requirements of the study protocol.
  • Patients must meet criteria for high risk AMM defined as:
  • Bone marrow plasma cells ≥ 10% and/or levels of monoclonal protein (M-protein) >3 g/dL and
  • Abnormal FLC ratio and absence of end organ damage (CRAB) defined as: lytic bone lesions on skeletal survey, calcium ≥ 11mg/dl, hemoglobin value of >2 g/100 ml below the lower limit of normal or a hemoglobin value <10 g/100 ml and renal insufficiency(serum creatinine >0.173 mmol/l) Note: Patients with BMPC > 60%, serum free light chain ratio >100, or known to have 2 or greater focal lesions on MRI and are clinically felt to require therapy will not be included.
  • Measurable disease defined by: M-spike >1 g/dL, or Bence Jones protein > 200 mg/24 hours by urine protein electrophoresis or involved serum free light chain (FLC) >10 mg /dl
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  • Adequate hematologic and end organ function, defined by the following laboratory results obtained within 28 days prior to the first study treatment (Cycle 1, Day 1):
  • ANC ≥ 1500 cells/ µL
  • WBC counts > 2500/ µL
  • Lymphocyte count ≥ 300/ µL
  • Platelet count ≥ 75,000/ µL
  • Total bilirubin within normal range
  • AST and ALT within normal range
  • Serum creatinine within normal range or creatinine clearance ≥ 60 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation:
  • (140 - age) x (weight in kg) x (0.85 if female) / 72 x (serum creatinine in mg/dL)
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of study drug.
  • A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
  • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below:
  • With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 90 days after the last dose of study drug. Men must refrain from donating sperm during this same period.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

Who cannot join

  • Patients who meet any of the following criteria will be excluded from study entry.
  • General Exclusion Criteria:
  • Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:
  • Herbal therapy > 1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1, Day 1)
  • AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia
  • Known liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
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  • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Inability to comply with study and follow-up procedures
  • History of active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, type 1 diabetes mellitus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, glomerulonephritis or autoimmune related dermatologic disease
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.).
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • History of HIV infection or known active hepatitis B (chronic or acute) or hepatitis C infection
  • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Active tuberculosis requiring therapy.
  • Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live, attenuated vaccine will be required during the study
  • Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccine (e.g., FluMist™) within 4 weeks prior to Cycle 1, Day 1 or at any time during the study.
  • Malignancies other than myeloma within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score ≤ 6, and prostate-specific antigen [PSA] ≤ 10 mg/mL, etc.).
  • Medication-Related Exclusion Criteria:
  • Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway targeting agents.
  • Treatment with another investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five half lives of the investigational product, whichever is longer)
  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1.
  • Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.
  • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale University

    New Haven, Connecticut, 06520

Other trials in United States

About this study

The purpose of this pilot study is to gain initial insights into the biologic and clinical effects of Atezolizumab in patients with Asymptomatic Multiple Myeloma (AMM). The data may provide novel insights into anti-PDL-1-induced immunologic changes, which could potentially be relevant to its future development in Multiple Myeloma (MM) and other indications.

Being tested
Atezolizumab (1200mg via IV infusion)
Medical subject headings
Smoldering Multiple Myeloma

What participants receive

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

  • Atezolizumab (1200mg via IV infusion)Drug

    Patients will get atezolizumab every 21 days for up to 1 year

Study groups in NCT02784483
Study groupRoleWhat they receive
Atezolizumab (1200mg via IV infusion)ExperimentalNot described
Receives: Drug: Atezolizumab (1200mg via IV infusion)

What is being measured

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

  1. Prevalence of anti-SOX2 reactive T cells after Anti-PDL1 therapy

    Presence or absence of SOX2 cells before and after anti-PDL1 therapy followed up to 1 year will be measured using antigen dependant stimulation.

    Measured: Up to 1 year

Timeline

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

  1. First posted27 May 2016 (estimated)
  2. Study start10 Feb 2017
  3. Primary completion15 Sep 2017
  4. Study completion22 Apr 2019

Why it stopped: Based on FDA requirements

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02784483
Sponsor's protocol ID
1511016813
Status last verified
Feb 2020
First submitted
24 May 2016
Last updated
3 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bar N, Costa F, Das R, Duffy A, Samur M, McCachren S, Gettinger SN, Neparidze N, Parker TL, Bailur JK, Pendleton K, Bajpai R, Zhang L, Xu ML, Anderson T, Giuliani N, Nooka A, Cho HJ, Raval A, Shanmugam M, Dhodapkar KM, Dhodapkar MV. Differential effects of PD-L1 versus PD-1 blockade on myeloid inflammation in human cancer. JCI Insight. 2020 Jun 18;5(12):e129353. doi: 10.1172/jci.insight.129353.

    PubMed 32427579

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atezolizumab (1200mg via IV infusion) in people with Asymptomatic Myeloma, run by Yale University at 1 site 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?

The sponsor lists 22 inclusion and 27 exclusion criteria. 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study was stopped early (reason given: Based on FDA requirements). Results are not available in the source record.

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?

Prevalence of anti-SOX2 reactive T cells after Anti-PDL1 therapy (time frame: Up to 1 year). 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 NCT02784483, which also lists 1 linked publication.

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 3 Mar 2020.

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