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.
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
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
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.
- Conditions
- Multiple Myeloma
- 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.
Dose-limiting toxicity
Measured: through cycle 1
Maximum tolerated dose
Measured: for the duration of the study
Secondary outcomes (3)
Qualitative and quantitative toxicities
Measured: for the duration of the study
Pharmacokinetics
Measured: for the duration of the study
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.
- First posted29 Jun 2006 (estimated)
- Study startApr 2005
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- ImmunoGen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asher Alban Akmal Chanan-Khan,, M.D., Principal investigator, Roswell Park Cancer Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00346255
- Acronym / sponsor ID
- IMGN901 / CDR0000491241
- Conditions
- Multiple Myeloma
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ImmunoGen, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BB-10901Also: IMGN901dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks. | Drug | – |
Primary outcome
Dose-limiting toxicity
Time frame: through cycle 1
Maximum tolerated dose
Time frame: for the duration of the study
3 secondary outcomes
Qualitative and quantitative toxicities
Time frame: for the duration of the study
Pharmacokinetics
Time frame: for the duration of the study
Anti-tumor activity including overall response rate, time to progression and survival
Time frame: for the duration of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asher Alban Akmal Chanan-Khan,, M.D. principal investigator
Roswell Park Cancer Institute
8 sites in 2 countries: see every site and its status.
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.