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Multiple MyelomaPhase 1NCT00726869

A Phase 1/2, Multi-center, Open-label, Dose-escalation Study of Elotuzumab(Humanized Anti-CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies.

A Phase 1 study testing Elotuzumab (HuLuc63) in people with Multiple Myeloma, run by Abbott at 8 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 Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate the combination of elotuzumab and bortezomib in subjects with MM following 1 to 3 prior therapies. 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?
Elotuzumab (HuLuc63)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
8 sitesUnited States
Study dates
May 2008to Mar 2012
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

  • Males or females, age 18 years or older.
  • Diagnosis of MM and documentation of 1 to 3 prior therapies.
  • M-protein spike (complete immunoglobulin molecule) of >= 1g/dL in serum and/or >= 0.5 g excreted in a 24-hour urine collection sample. Light chain only disease is not an inclusion criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • No prior bortezomib treatment OR responsive (PR or better) to prior bortezomib treatment for a minimum of 3 months OR responsive to prior bortezomib treatment at the time of going to another treatment or ceasing treatment.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <=3 x upper limit of normal (ULN).
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  • Total bilirubin <=2 x ULN.
  • 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 (1.0 x 10^9 cells/L) without growth factor support for 7 days;
  • Platelets >=75,000 cells/mm3 (75 x 10^9 cells/L) without transfusion within 72 hours of screening;
  • Hemoglobin >=8 g/dL without red blood cell transfusion within 2 weeks of screening;
  • Serum calcium (corrected for albumin) level at or below ULN range (treatment of hypercalcemia is allowed and subject may enroll if hypercalcemia returns to normal with standard treatment); additional screening time may be allowed for confirmation - consult with sponsor's medical monitor.
  • Use of appropriate contraception where applicable.
  • Negative urine pregnancy test where applicable.
  • Must have 2-dimensional echocardiogram indicating left ventricular ejection fraction (LVEF) >=45% within 30 days prior to the first dose of elotuzumab.
  • 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

  • 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 2 years.
  • Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary,(including acute diffuse infiltrative pulmonary and pericardial disease), hepatic, and renal diseases unless renal insufficiency is felt to be secondary to MM.
  • Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
  • Prior treatment with bortezomib in 3 months prior to the first dose.
  • Thalidomide, lenalidomide cytotoxic chemotherapy, or corticosteroids (except prior to infusion of first dose of study drug as prophylaxis for infusion reactions) within 2 weeks of the first dose of elotuzumab.
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  • Prior therapy with anti-CD56+ therapeutics.
  • Radiotherapy within 2 weeks prior to the first dose of elotuzumab.
  • Investigational drug within 3 weeks or 3x the half-life of the investigational drug (whichever is longer ) of the first dose of elotuzumab.
  • Prior peripheral stem cell transplant within 12 weeks of the first dose of elotuzumab.
  • Nitrogen mustard agents, melphalan, or monoclonal antibodies within 6 weeks of the first dose of elotuzumab.
  • Neuropathy >=Grade 2 (NCI CTCAE v3.0).
  • Current orthostatic hypotension.
  • Known active infections requiring antibiotic, antiviral, or antifungal therapy.
  • Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation.
  • Any condition that in the investigator's opinion makes the subject unsuitable for study participation.
  • Hypersensitivity to recombinant proteins or excipients in elotuzumab or bortezomib.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Site Reference ID/Investigator# 63852

    Ann Arbor, Michigan, 48109-5936

  • Site Reference ID/Investigator# 63847

    Boston, Massachusetts, 02115

  • Site Reference ID/Investigator# 63850

    Buffalo, New York, 14263

  • Site Reference ID/Investigator# 63855

    Chicago, Illinois, 60637

  • Site Reference ID/Investigator# 63849

    Columbus, Ohio, 43210

  • Site Reference ID/Investigator# 63854

    Hackensack, New Jersey, 07601

  • Site Reference ID/Investigator# 63853

    Los Angeles, California, 90033

  • Site Reference ID/Investigator# 63848

    Seattle, Washington, 98109

Other trials in United States

About this study

This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate the combination of elotuzumab and bortezomib in subjects with MM following 1 to 3 prior therapies. For the Phase 1 portion, elotuzumab will be administered by intravenous (IV) infusion at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes following the administration of bortezomib at 1.3 mg/m^2 IV bolus. Bortezomib will be given in 21 day cycles (twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest period). Elotuzumab will be administered as a separate infusion within 30 minutes following bortezomib administration on the same days as the first and last dose of each bortezomib cycle (i.e., Days 1 and 11).

Read the detailed description

The phase 2 portion of this study was not initiated because a decision was made to conduct a phase 2 randomized clinical trial.

Being tested
Elotuzumab (HuLuc63)
Keywords
Patients After One to three Prior Therapies
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Elotuzumab (HuLuc63)Drug

    Also called Elotuzumab

    Cohort 1 - 2.5 mg/kg elotuzumab IV with bortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8; Cohort 2 - 5.0 mg/kg elotuzumab IV with bortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8; Cohort 3 - 10.0 mg/kg elotuzumab IV withbortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8; and Cohort 4 - 20.0 mg/kg elotuzumab IV with bortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8.

Study groups in NCT00726869
Study groupRoleWhat they receive
Cohort 1Experimental2.5 mg/kg
Receives: Drug: Elotuzumab (HuLuc63)
Cohort 2Experimental5.0 mg/kg
Receives: Drug: Elotuzumab (HuLuc63)
Cohort 3Experimental10.0 mg/kg
Receives: Drug: Elotuzumab (HuLuc63)
Cohort 4Experimental20.0 mg/kg
Receives: Drug: Elotuzumab (HuLuc63)

What is being measured

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

  1. Identify the maximum tolerated dose of elotuzumab in combination with bortezomib (phase 1).

    The highest dose level of elotuzumab at which <= 1 dose-limiting toxicity occurs in 6 subjects

    Measured: First cycle of treatment.

  2. Evaluate the efficacy of elotuzumab in combination with bortezomib (phase 2).

    Objective response rate (complete and partial response) according to European Group for Blood and Marrow Transplantation (EBMT) criteria

    Measured: Screening to the 30 day follow up visit.

Secondary outcomes (5)

  1. Evaluate the efficacy of elotuzumab in combination with bortezomib (phase 1).

    Objective response rate according to EBMT criteria, duration of response, time to progression, and progression-free survival

    Measured: Screening to the 30 day follow up visit.

  2. Evaluate the safety of elotuzumab in combination with bortezomib (phase 1 and 2).

    Frequency, severity, and relationship of adverse events and serious adverse events with the combination of elotuzumab and bortezomib

    Measured: Screening to the 30 day follow up visit.

  3. Evaluate the pharmacokinetic parameters of elotuzumab in combination with bortezomib (phase 1 and 2)

    Pharmacokinetic profile

    Measured: Screening to the 30 day follow up visit.

  4. Evaluate the immunogenicity of elotuzumab in combination with bortezomib (phase 1 and 2).

    Incidence of elotuzumab-specific antidrug antibodies

    Measured: Screening to the 30 day follow up visit.

  5. Evaluate the pharmacodynamics of elotuzumab in combination with bortezomib (phase 1 and 2).

    Changes in pharmacodynamic endpoints as they relate to dose, response, and toxicity of elotuzumab in combination with bortezomib

    Measured: Screening to the 30 day follow up visit.

Timeline

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

  1. First posted1 Aug 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionMar 2012
  4. Study completionMar 2012

Why it stopped: Enrollment has been halted

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00726869
Sponsor's protocol ID
HuLuc63-1702
Status last verified
Jun 2012
First submitted
29 Jul 2008
Last updated
23 Aug 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Elotuzumab (HuLuc63) in people with Multiple Myeloma, run by Abbott 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 17 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: stopped early, as of the sponsor's last update on 23 Aug 2012. 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 was stopped early (reason given: Enrollment has been halted). 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?

Identify the maximum tolerated dose of elotuzumab in combination with bortezomib (phase 1). (time frame: First cycle of treatment.). 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 NCT00726869.

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 Aug 2012.

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Clinical Trial NCT00726869 | AzTrials