Multiple Myeloma Clinical Trial
— IMGN901Official 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
Verified date | April 2013 |
Source | ImmunoGen, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Gascon 450 - (C1181ACH) | Buenos Aires | Capital Federal |
Argentina | Juan Domingo Peron 1500 - (B1629AHJ) Pilar | Buenos Aires | |
Argentina | Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield | Córdoba | |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Cedars-Sinai Outpatient Cancer Center | Los Angeles | California |
United States | St. Vincent's Comprehensive Cancer Center - Manhattan | New York | New York |
United States | UCSF | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
ImmunoGen, Inc. |
United States, Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicity | through cycle 1 | Yes | |
Primary | Maximum tolerated dose | for the duration of the study | Yes | |
Secondary | Qualitative and quantitative toxicities | for the duration of the study | Yes | |
Secondary | Pharmacokinetics | for the duration of the study | No | |
Secondary | Anti-tumor activity including overall response rate, time to progression and survival | for the duration of the study | No |
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