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Multiple MyelomaPhase 1NCT00723359

Safety and Dose Determining Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1 study testing BT062 in people with Multiple Myeloma, run by Biotest Pharmaceuticals Corporation at 4 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

This Phase I research study is to test the effects (good and bad) and best dose of BT062 in treating 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
Multiple Myeloma
What is being tested?
BT062
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
4 sitesUnited States
Study dates
Aug 2008to Apr 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

  • Diagnosis of active multiple myeloma according to the International Myeloma Working Group diagnostic criteria
  • Relapsed or relapsed/refractory multiple myeloma
  • Previous treatment with both an immunomodulator and a proteosome inhibitor therapy
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status (Zubrod) ≤ 2
  • Ability to understand and willingness to sign a written informed consent document
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  • Ability to adhere with the study visit schedule and other protocol procedures
  • Life expectancy of ≥ 12 weeks
  • Normal organ and marrow function

Who cannot join

  • Chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C)prior to day 1 or those who have not recovered from AEs due to agents administered more than 3 weeks earlier
  • Treatment with another investigational agent during the study or within 4 weeks before day 1
  • Major surgery within 4 weeks before day 1 (this does not include placement of vascular access device or tumor biopsies)
  • Antineoplastic therapy with biological agents within 2 weeks before day 1
  • HAHAs, HACAs, or HAMAs in response to previous MAb therapy
  • Previous participation in this study
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  • Malignancy within 3 years before day 1, excluding treated non-melanoma skin cancer, superficial bladder cancer and carcinoma in-situ of the cervix
  • Severe diseases of skin, colon, esophagus, or eye within 1 year before day 1, as judged by the Investigator
  • Severe infections necessitating use of antibiotics
  • Clinically relevant active infection including active hepatitis B or C or human immunodeficiency virus (HBV, HCV, or HIV) or any other concurrent disease which,in the judgment of the investigator, would make the subject inappropriate for enrollment into this study
  • Acute or relevant abnormalities in electrocardiogram (ECG), as judged by the Investigator
  • Significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to day 1), unstable angina, uncontrolled congestive heart failure, uncontrolled hypertension, (recurrent or persistent increases in systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg), uncontrolled cardiac arrhythmias, grade 3 or greater cardiac toxicity from prior chemotherapy
  • History of clinically significant drug or alcohol abuse
  • Unwillingness or inability to adhere to the requirements of the study
  • Concomitant therapy with corticosteroids (except as indicated in low dose for other medical conditions such as inhaled steroid for asthma, or as premedication for administration of certain medications or blood products and for treatment of infusion reactions if needed)
  • Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study
  • Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he or she are included in the study
  • Pregnant or breast-feeding
  • Unwillingness to use an effective contraceptive method during the study and at least 3 months after administration of study drug - unless subject is naturally infertile. (Acceptable contraceptive methods include oral or injectable contraceptives, intrauterine devices (IUD), double-barrier method, contraceptive patch, surgical sterilization, or condoms.)
  • Positive serum or urine pregnancy test

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Mount Sinai Medical Center

    New York, New York, 10029

Other trials in United States

About this study

Official title: A Phase I Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), and Safety of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma

This Phase I research study is to test the effects (good and bad) and best dose of BT062 in treating patients with relapsed or refractory multiple myeloma.

Being tested
BT062
Keywords
Multiple Myeloma, Refractory, Relapsed
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

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

  • BT062Drug

    biologic

Study groups in NCT00723359
Study groupRoleWhat they receive
BT062ExperimentalBT062 single agent dose escalation
Receives: Drug: BT062

What is being measured

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

  1. Dose limiting toxicity

    Measured: On a weekly basis for the duration of the study

  2. Maximum tolerated dose

    Measured: About every 2 months for the duration of the study

Secondary outcomes (3)

  1. Qualitative and quantitative toxicities

    Measured: On a weekly basis for the duration of the study

  2. Pharmacokinetics

    Measured: On a weekly basis for the duration of the study

  3. Anti-tumor activity

    Measured: At the beginning of each treatment cycle

Timeline

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

  1. First posted28 Jul 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionApr 2012
  4. Study completionApr 2012

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00723359
Sponsor's protocol ID
969
Status last verified
Jul 2013
First submitted
24 Jul 2008
Last updated
18 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BT062 in people with Multiple Myeloma, run by Biotest Pharmaceuticals Corporation 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?

The sponsor lists 9 inclusion and 20 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 18 Jul 2013. 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?

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?

Dose limiting toxicity (time frame: On a weekly basis for the duration of the study). 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 NCT00723359.

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 18 Jul 2013.

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