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Multiple MyelomaPhase 1/2NCT01435720

Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)

A Phase 1/2 study testing SNS01-T in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Senesco Technologies, Inc. at 7 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by intravenous infusion at various doses. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SNS01-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
7 sitesin 2 countries
Study dates
Sep 2011to Dec 2014
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • B cell lymphoma patients must have had their diagnosis confirmed histologically. Plasma cell leukemia (PCL) patients must have peripheral clonal plasma cells >20% of peripheral WBC and >2 x 109/L. Multiple myeloma and PCL patients must have been diagnosed by having met all three of the following IMWG criteria:
  • Clonal bone marrow plasma cells >10%
  • Presence of serum and/or urinary M-protein or, if absent, kappa or lambda serum FLC must be > 10 mg/dl accompanied by an abnormal kappa to lambda ratio (<0.26 or >1.65)
  • Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically, one or more of the following:
  • Hypercalcemia: serum calcium >11.5 mg/100 mL
  • Renal insufficiency: serum creatinine >2mg/dL
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  • Anemia: normochromic, normocytic with a hemoglobin value >2 g/100 mL below the lower limit of normal or a hemoglobin value <10 g/100 mL
  • Bone lesions: lytic lesions, severe osteopenia, or pathologic fractures
  • B cell lymphoma patients must have measurable disease defined as at least one lesion that can be accurately measured for response in at least two perpendicular dimensions. Multiple myeloma patients must have measurable disease defined by the following:
  • Serum M-protein ≥0.5g/dL or urine M-protein ≥ 200 mg/24 hours by protein electrophoresis
  • If neither serum nor urine M-protein meet the criteria above, then kappa or lambda serum FLC must be ≥10 mg/dL accompanied by an abnormal kappa to lambda ratio (<0.26 or >1.65) (Serum FLC should only be used for patients without measurable serum or urine M-protein spike.)
  • If neither of the above criteria are met, the presence of plasmacytomata measurable radiographically (CT, PET or MRI) or by direct measurement.
  • Have relapsed or refractory disease after two or more prior treatment lines, each of which may have consisted of either single or multiple regimens. The investigators will ensure that patients have had the benefit of standard treatments before considering the SNS01-T clinical trial.
  • Be at least 2 weeks beyond the last therapy and have recovered from acute toxicities of prior therapies
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Have life expectancy of at least 3 months
  • Be ≥18 years of age and willing to provide written informed consent
  • For women and men of childbearing potential, have used effective contraceptive methods for at least 4 weeks prior to dosing and agree to continue using such methods during the study, and for at least 4 weeks after completing the study
  • For women of childbearing potential, have a negative serum pregnancy test within 24 hours before the initiation of SNS01-T therapy
  • Have an absolute neutrophil count >1,000/mm3
  • Have a platelet count >75,000/mm3
  • Have total bilirubin <2.0 mg/dL
  • Have aspartate aminotransferase and alanine aminotransferase <3 times the upper limit of normal
  • Have serum creatinine ≤3 times the upper limit of normal
  • Have hemoglobin ≥8.0 g/dL

Who cannot join

  • Have presence of nonsecretory myeloma
  • Have an indolent lymphoma such as follicular lymphoma unless the disease is rapidly progressing
  • Requires renal dialysis
  • Have New York Heart Association Class III-IV heart failure classification
  • Have CNS or leptomeningeal disease
  • Have an active infection or serious comorbid medical condition
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  • Be receiving other concurrent anticancer agents or therapies
  • Be receiving other concurrent investigational therapies or have received investigational therapies within 4 weeks of screening or 5 half-lives, if known, whichever is shorter
  • Be eligible to receive any other standard therapy available that is known to extend life expectancy
  • Be currently receiving steroids unless equivalent to 20 mg of prednisone or less
  • Be receiving or have received heparin therapeutically within two days before and after treatment with SNS01-T
  • Be pregnant or nursing

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States5 sites

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • West Virginia University Mary Babb Randolf Cancer Center

    Morgantown, West Virginia, 26506

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Fred Hutchinson Cancer Research Center/University of Washington Medical Center

    Seattle, Washington, 98109

Other trials in United States

South Africa2 sites

  • Unversity of Cape Town - Groote Schuur Hospital

    Cape Town

  • Pretoria East Hospital

    Pretoria

Other trials in South Africa

About this study

Official title: Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of SNS01-T Administered by Intravenous Infusion in Patients With Relapsed or Refractory B Cell Malignancies

The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by intravenous infusion at various doses.

Read the detailed description

The main purpose is to test the safety and tolerability of SNS01-T. The first group of patients with relapsed or refractory multiple myeloma, plasma cell leukemia or B cell lymphoma will be given a relatively low dose. If tolerated, a second group will receive a higher dose. If tolerated by the second group, a third and then a fourth group will receive higher doses. Treatment-related adverse events (side effects), changes in vital signs, physical examination, and laboratory values will be monitored. Patients will receive twice weekly infusions for 6 weeks and then will be followed monthly for 6 months. A secondary purpose is to explore whether SNS01-T is an effective treatment for multiple myeloma, B cell lymphoma and plasma cell leukemia.

Being tested
SNS01-T
Keywords
Multiple myeloma, B cell lymphoma, Hematologic disease, Blood protein disorder, Neoplasm, plasma cell, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma, Plasma Cell Leukemia, B cell malignancy
Medical subject headings
Multiple Myeloma, Leukemia, Plasma Cell, Lymphoma, B-Cell, Hematologic Diseases, Blood Protein Disorders, Neoplasms, Plasma Cell, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • SNS01-TBiological

    0.05 mg/kg twice weekly x 6 weeks

  • SNS01-TBiological

    0.2 mg/kg twice weekly x 6 weeks

  • SNS01-TBiological

    0.375 mg/kg twice weekly x 6 weeks

  • SNS01-TBiological

    0.0125 mg/kg twice weekly x 6 weeks

Study groups in NCT01435720
Study groupRoleWhat they receive
Cohort 1Experimental0.0125 mg/kg
Receives: Biological: SNS01-T
Cohort 2Experimental0.05 mg/kg
Receives: Biological: SNS01-T
Cohort 3Experimental0.2 mg/kg
Receives: Biological: SNS01-T
Cohort 4Experimental0.375 mg/kg
Receives: Biological: SNS01-T

What is being measured

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

  1. Safety and tolerability

    Safety and Tolerability assessed by frequency, severity, and duration of treatment-related adverse events, changes in vitals signs, physical exams and lab values

    Measured: Week 6

Secondary outcomes (2)

  1. Profile of pharmacokinetics

    Cmax, area under curve, Tmax. Performed on Weeks 1, 3, 6, 10, 14, 18

    Measured: 0.5 hours pre-dose and 0.5, 2, 6 and 24 hours post-dose

  2. Explore tumor response

    IMWG criteria, changes in M-protein, etc. for myeloma and plasma cell leukemia; Lymphoma response criteria, CT/PET scans for B cell lymphoma

    Measured: Weeks 3 and 6, and monthly during a 24-week follow-up period

Timeline

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

  1. First posted19 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionOct 2014 (estimated)
  4. Study completionDec 2014 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01435720
Sponsor's protocol ID
SNS01-T-001
Status last verified
Sep 2014
First submitted
14 Sep 2011
Last updated
11 Sep 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SNS01-T in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Senesco Technologies, Inc. at 7 sites in 2 countries.

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 25 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, South Africa. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

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?

Safety and tolerability (time frame: Week 6). 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 NCT01435720.

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 11 Sep 2014.

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