- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00991562
IMGN901 in Combination With Lenalidomide and Dexamethasone
November 20, 2014 updated by: ImmunoGen, Inc.
An Open-Label Phase I Study of Bb-10901 (IMGN901, huN901-DM10 in Combination With Lenalidomide and Dexamethasone in Patients With CD56-positive Relapsed or Relapsed/Refractory Multiple Myeloma
The purpose of this study is to test IMGN901 in combination with lenalidomide and dexamethasone every 28 days.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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Palm Springs, California, United States, 92262
- Comprehensive Cancer Center of the Desert
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Florida
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Sarasota, Florida, United States, 34232
- Florida Cancer Specialists
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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New York, New York, United States, 10021
- Weill Medical College
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Texas
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San Antonio, Texas, United States, 78229
- CTRC at University of Texas Health Science Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of multiple myeloma based on standard criteria.
- Patients must have CD56-positive, relapsed or relapsed/refractory multiple myeloma. Myeloma is considered CD56-positive if either immunohistochemistry (IHC) or flow cytometry criteria defined in Appendix X are met.
- Age < 18 years at the time of signing Informed Consent.
- Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- During the dose escalation phase, patients must have received at least one prior therapy for multiple myeloma. The prior therapy or therapies can include lenalidomide treatment.
Once the MTD/RPTD is defined, only patients who have received at least 1 but no more than 3 prior chemotherapy regimens will be enrolled at this dose level in the study. Prior regimen(s) may have included bortezomib or a bortezomib component. If prior regimen(s) included a lenalidomide component:
- Patients last dose of lenalidomide must be ≥ 6 months from Day 1 treatment with BB-10901 (with the exception of maintenance lenalidomide treatment which should be completed at least 4 weeks prior to Day 1 treatment with BB-10901) ,
- Patients must have achieved a response of stable disease or better to any lenalidomide treatment, and
- Patients must not have discontinued treatment due to lenalidomide intolerance.
- Patients must be able to adhere to the study visit schedule and other protocol requirements.
- Patients must understand and voluntarily sign an informed consent document.
- Woman of child bearing potential (WCBP) must have a negative pregnancy test within 10 - 14 days and within 24 hours prior to writing an initial prescription for lenalidomide even if continuous abstinence is the chosen method of birth control. In addition, all sexually active WCBP must agree to frequent pregnancy tests as outlined in the protocol and must agree to use 2 contraceptive methods. WCBP must agree to follow these requirements for at least 4 weeks before beginning treatment with lenalidomide and for at least 4 weeks after the last treatment of lenalidomide.
- Male patients must agree to use a latex condom even if he has had a successful vasectomy and males can not donate sperm. Males must agree to follow these requirements for at least 4 weeks following last dose of study drug.
- Patients may have received chemotherapy or wide-field radiotherapy (e.g. .30% of marrow-bearing bones) if completed at least 4 weeks prior to Day 1, or focal radiation completed at least 2 weeks prior to Day 1, and the patient has recovered or stabilized from all adverse effects of such therapy. Therapy with nitrosoureas or mitomycin C must be completed 6 weeks prior to Day 1. Major surgery (this does not include placement of vascular access device or tumor biopsies) must be completed 4 weeks prior to Day 1. Antineoplastic therapy with biological agents must be completed at least 2 weeks prior to Day 1.
- Absolute neutrophil count (ANC) ≥ 1000 cells/mm3, hemoglobin ≥ 8.5 g/dL, and platelet count ≥ 50,000/mm3
- Aspartate aminotransferase(AST) (serum glutamic oxalacetic transaminase, SGOT) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase, SGPT) ≤ 3 x upper limit of normal (ULN) and total bilirubin ≤ 1.5 x ULN
- Amylase and lipase levels must be ≤ 1.5 x ULN.
- Serum Creatinine ≤ 1.5 x ULN
- Left ventricular ejection fraction ≥ lower limit of normal (LLN) on MUGA scan or ECHO.
- Patients must agree to follow all guidelines from the RevAssist® Program
Exclusion Criteria:
- Concomitant therapy with other antineoplastic treatments (chemotherapy, radiotherapy or biological agents) during the study.
- Peripheral neuropathy of grade 2 or greater.
- Known hypersensitivity to lenalidomide or other thalidomide derivatives, previous monoclonal antibody therapy or maytansinoids.
- History of deep venous thrombus or pulmonary embolism within 6 months of study enrollment.
- Any serious medical condition, laboratory abnormalities, or psychiatric disorder, that in the opinion of the Investigator places the patients at unacceptable risk if he/she were to participate in the study.
- Clinically relevant active infection including active hepatitis B or C, Human Immunodeficiency Virus (HIV) infection, or any other concurrent disease which, in the judgment of the Investigator, would make the patients inappropriate for enrollment into this study.
- 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 mmHg or diastolic blood pressure ≥ 110 mmHg ), uncontrolled cardiac arrhythmias, grade 3 or greater cardiac toxicity following prior chemotherapy.
- History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, central nervous system (CNS) injury with residual neurological deficit, or alcoholic liver disease.
- Treatment with another investigational agent during the study or ≤ 4 weeks prior to Day 1.
- Prior malignancy within the last 3 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer.
- Patients who have any known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas that is associated with an increased amylase and/or lipase will be excluded. (Note: Enrollment of patients with any metastatic disease to, or around, the pancreas may be allowed only with agreement between the Sponsor and the Investigator).
- WCBP who are pregnant or breast feeding or men and women not using adequate contraception are excluded.
- Patients unwilling or unable to comply with the requirements of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the MTD/RPTD and response rate To assess the response rate of the combination at the MTD, in the patient population
Time Frame: during study
|
during study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate (OR and CR), duration of responses, time to progression, progression-free survival, and overall survival and pharmacodynamics.
Time Frame: during the study
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during the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
October 7, 2009
First Submitted That Met QC Criteria
October 7, 2009
First Posted (Estimate)
October 8, 2009
Study Record Updates
Last Update Posted (Estimate)
November 21, 2014
Last Update Submitted That Met QC Criteria
November 20, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Ado-Trastuzumab Emtansine
- Lorvotuzumab mertansine
Other Study ID Numbers
- IMGN0005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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