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Multiple MyelomaPhase 1IMGN901NCT00346255

BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma

A Phase 1 study testing BB-10901 in people with Multiple Myeloma, run by ImmunoGen, Inc. at 8 sites in 2 countries.

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

RATIONALE: Monoclonal antibodies, such as BB-10901, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. 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?
BB-10901
Type of treatment
Injection or infusion
How many people
37 participants
Where
8 sitesin 2 countries
Study dates
Apr 2005to Mar 2011
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed multiple myeloma
  • Relapsed or relapsed/refractory disease
  • Failed ≥ 1 prior therapy for multiple myeloma
  • Once the MTD is defined, only patients who have received at least 1 but equal or less than 6 prior chemotherapy regimens will be enrolled at this dose level
  • CD56-positive disease confirmed by immunohistochemistry or flow cytometry

PATIENT CHARACTERISTICS:

  • ECOG (Zubrod) performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Platelet count ≥ 75,000/mm^3
  • Absolute neutrophil count > 1,000/mm^3
  • Hemoglobin ≥ 8.5 g/dL
  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Amylase and lipase within normal limits
  • Creatinine ≤ 2 mg/dL
  • Left ventricular ejection fraction ≥ lower limit of normal on MUGA or ECHO
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No peripheral neuropathy ≥ grade 3 or painful grade 2 neuropathy
  • No significant cardiac disease, including any of the following:
  • Myocardial infarction within the past 6 months
  • Unstable angina
  • Uncontrolled congestive heart failure
  • Uncontrolled hypertension (i.e., recurrent or persistent increases in systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg)
  • Uncontrolled cardiac arrhythmias
  • Cardiac toxicity ≥ grade 3 after prior chemotherapy
  • No history of multiple sclerosis or other demyelinating disease
  • No hemorrhagic or ischemic stroke within the past 6 months
  • No Eaton-Lambert syndrome (para-neoplastic syndrome)
  • No CNS injury with residual neurological deficit (other than peripheral neuropathy ≤ grade 2)
  • No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer
  • No clinically relevant active infection, including active hepatitis B or C infection or HIV infection
  • No other condition or disease, including laboratory abnormalities, that, in the opinion of the investigator, may preclude study treatment
  • No known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • At least 4 weeks since prior radiotherapy
  • At least 4 weeks since prior major surgery (except placement of a vascular access device or tumor biopsies)
  • More than 4 weeks since prior investigational agents
  • At least 2 weeks since prior antineoplastic therapy with biological agents
  • No prior hypersensitivity to monoclonal antibody therapy
  • No other concurrent investigational agents
  • No concurrent corticosteroids (except as indicated for other medical conditions [< 10 mg prednisone or equivalent]; as pre-medication for administration of certain medications or blood products [≤ 100 mg hydrocortisone]; or for treatment of infusion reactions)
  • Concurrent topical steroids allowed
  • No other concurrent antineoplastic treatment (e.g., chemotherapy, radiotherapy, or biological agents)
  • Concurrent bisphosphonates allowed provided patient began bisphosphonates before study entry and is maintained on a stable dose during study treatment

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States5 sites
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Cedars-Sinai Outpatient Cancer Center

    Los Angeles, California

  • St. Vincent's Comprehensive Cancer Center - Manhattan

    New York, New York, 10011

  • UCSF

    San Francisco, California, 94143

Other trials in United States

Argentina3 sites
  • Juan Domingo Peron 1500 - (B1629AHJ) Pilar

    Buenos Aires, Buenos Aires

  • Gascon 450 - (C1181ACH)

    Buenos Aires, Buenos Aires F.D.

  • Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield

    Córdoba, Córdoba Province

Other trials in Argentina

About this study

Official title: A Phase I Study to Assess The Safety and Pharmacokinetics of BB-10901 (huN901-DM1) Given as an Intravenous Infusion Weekly for Two Consecutive Weeks Every Three Weeks to Subjects With Relapsed and Relapsed Refractory CD56-Positive Multiple Myeloma

RATIONALE: Monoclonal antibodies, such as BB-10901, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed and/or refractory multiple myeloma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the dose-limiting toxicity and the maximum tolerated dose of BB-10901 in patients with relapsed and/or refractory CD56-positive multiple myeloma.

Secondary

  • To determine the qualitative and quantitative toxicities of BB-10901 administered on this schedule.
  • To evaluate the pharmacokinetics of BB-10901.
  • To recommend a dose for Phase II clinical studies with BB-10901 given on this specific regimen.
  • To observe any evidence of anti-tumor activity with BB-10901.

Objectives of MTD Expansion Cohort

  • To evaluate response rate including overall response rate (ORR) and complete response rate (CRR), and duration of response (DOR).
  • To further assess time to progression (TTP), progression free survival (PFS), and overall survival (OS).

OUTLINE: This is an open-label, non-randomized, dose-escalation, multicenter study.

Patients receive BB-10901 IV over 1-2 hours on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BB-10901 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Up to 40 patients are treated at the MTD.

After completion of study treatment, patients are followed for short term follow-up and long term (up to 3 years) survival status.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Being tested
BB-10901
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

  • BB-10901Drug

    Also called IMGN901

    dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks.

What is being measured

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

  1. Dose-limiting toxicity

    Measured: through cycle 1

  2. Maximum tolerated dose

    Measured: for the duration of the study

Secondary outcomes (3)
  1. Qualitative and quantitative toxicities

    Measured: for the duration of the study

  2. Pharmacokinetics

    Measured: for the duration of the study

  3. Anti-tumor activity including overall response rate, time to progression and survival

    Measured: for the duration of the study

Timeline

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

  1. First posted29 Jun 2006 (estimated)
  2. Study startApr 2005
  3. Primary completionMar 2011
  4. Study completionMar 2011

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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00346255
Sponsor's protocol ID
CDR0000491241
Other IDs
IMMUNO-003, DFCI-05031
Acronym
IMGN901
Status last verified
Apr 2013
First submitted
28 Jun 2006
Last updated
23 Apr 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BB-10901 in people with Multiple Myeloma, run by ImmunoGen, Inc. at 8 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?

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 Apr 2013. 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, Argentina. 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: through cycle 1). 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?
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 Apr 2013.

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