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Multiple MyelomaPhase 1NCT00425347

Phase I, Multi-Center, Open-Label, Dose Escalation Study of HuLuc63 in Subjects With Advanced Multiple Myeloma

A Phase 1 study testing HuLuc63 in people with Multiple Myeloma, run by Facet Biotech at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To identify the MTD of HuLuc63 administered intravenously (IV) for 4 doses.2. To evaluate the safety of HuLuc63 IV given every other week for 4 doses. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
HuLuc63
How many people
35 participants
Where
8 sitesUnited States
Study dates
Dec 2006to Jul 2009
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
  • Males or females, age 18 years or older.
  • Diagnosis of advanced multiple myeloma, after at least 2 prior therapies for MM.
  • Measurable disease M component in serum (at least 0.5 G/dL) and/or urine (≥0.2 g excreted in a 24-hour collection sample).
  • Not eligible for stem cell or bone marrow transplant or have refused stem cell or bone marrow transplant or have relapsed after autologous or allogeneic stem cell or bone marrow transplant.
  • ECOG performance status 0-2 (Appendix E).
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  • ALT or AST ≤3 x ULN.
  • Total bilirubin ≤2 x ULN (unless related to MM).
  • Serum creatinine ≤2.0 mg/dL (unless related to MM, then ≤ 3.0 mg/dL).
  • Must have adequate bone marrow function defined as: Absolute neutrophil count >1,000 cells/mm3; platelets ≥75,000 cells/mm3; and hemoglobin ≥8 g/dL. No platelet transfusion within 72 hours of obtaining screening platelet count.
  • Serum calcium (corrected for albumin) level within normal range (treatment of hypercalcemia is allowed and subject may enroll if hypercalcemia returns to normal with treatment).
  • Signed and dated informed consent.
  • Use of appropriate contraception where applicable.
  • Negative pregnancy test within 48 hours prior to first dose in women of childbearing potential.
  • Must have 2-dimensional echocardiogram or MUGA indicating LVEF ≥ 45% within 30 days prior to first dose of study drug.
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).

Who cannot join

  • Subjects will be ineligible for this study if they meet any one of the following criteria:
  • Life expectancy of less than 3 months.
  • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years.
  • Plasma cell leukemia (active or prior).
  • Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary, hepatic, and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma (serum creatinine > 2.0 mg/dL).
  • Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
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  • Corticosteroid, Velcade® or other proteosome inhibitor, thalidomide, lenalidomide (Revlimid®), or melphalan within 2 weeks of the first dose of HuLuc63; nitrogen mustard agents within 6 weeks of the first dose of HuLuc63.
  • Investigational drug within 4 weeks or 5 half-lives (whichever is greater) of the first dose of HuLuc63.
  • Stem cell or bone marrow transplant within 12 weeks prior to the first dose of HuLuc63.
  • Biological agents including intravenous immune globulin (IVIG) and monoclonal antibodies within 4 weeks of the first dose of HuLuc63.
  • Neuropathy >Grade 2 (according to the NCI CTCAE v3.0 criteria scale).
  • Symptomatic orthostatic hypotension.
  • Evidence of amyloidosis.
  • Known active infections requiring antibiotics, antivirals, or antifungals.
  • Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation.
  • Hypersensitivity to recombinant proteins or excipients in the investigational agent.
  • Any condition that in the investigator's opinion makes the subject unsuitable for study participation.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Wayne State University

    Detroit, Michigan, 48201

  • Arkansas Cancer Research Center

    Little Rock, Arkansas, 72205

  • USC/Norris Cancer Hospital

    Los Angeles, California, 90033

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • University of Massachusetts Memorial Healthcare- Univ. Campus

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Phase I, Multi-Center, Open-Label, Dose Escalation Study of HuLuc63 (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Subjects With Advanced Multiple Myeloma

To identify the MTD of HuLuc63 administered intravenously (IV) for 4 doses.2. To evaluate the safety of HuLuc63 IV given every other week for 4 doses.

Being tested
HuLuc63
Keywords
Multiple myeloma, MM, plasma cell myeloma, cancer
Medical subject headings
Multiple Myeloma, Neoplasms

What participants receive

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

  • HuLuc63Drug

    Not applicable for HuLuc63.

What is being measured

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

  1. Not applicable for this trial.

    Measured: Not applicable for this trial.

Timeline

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

  1. First posted22 Jan 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionAug 2008
  4. Study completionJul 2009

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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00425347
Sponsor's protocol ID
HuLuc63-1701
Status last verified
Sep 2009
First submitted
18 Jan 2007
Last updated
23 Sep 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HuLuc63 in people with Multiple Myeloma, run by Facet Biotech at 8 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?

The sponsor lists 16 inclusion and 17 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: finished, as of the sponsor's last update on 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Not applicable for this trial. (time frame: Not applicable for this trial.). 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 NCT00425347.

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 23 Sep 2009.

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