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IMGN901 in Combination With Lenalidomide and Dexamethasone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00991562
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : November 21, 2014
Information provided by (Responsible Party):
ImmunoGen, Inc.

Brief Summary:
The purpose of this study is to test IMGN901 in combination with lenalidomide and dexamethasone every 28 days.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: IMGN901 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Intervention Details:
  • Drug: IMGN901
    dose escalation study. dosing on days 1, 8 and 15 every 28 days
    Other Names:
    • BB-10901
    • huN901-DM1

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00991562

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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Comprehensive Cancer Center of the Desert
Palm Springs, California, United States, 92262
United States, Florida
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Weill Medical College
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
CTRC at University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
ImmunoGen, Inc.
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Responsible Party: ImmunoGen, Inc. Identifier: NCT00991562    
Other Study ID Numbers: IMGN0005
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014
Keywords provided by ImmunoGen, Inc.:
relapsed or relapsed/refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lorvotuzumab mertansine
Ado-trastuzumab emtansine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action