Trial record 1 of 1 for:    NCT00991562
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IMGN901 in Combination With Lenalidomide and Dexamethasone

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT00991562
First received: October 7, 2009
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: IMGN901
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: August 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: IMGN901
    dose escalation study. dosing on days 1, 8 and 15 every 28 days
    Other Names:
    • BB-10901
    • huN901-DM1
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991562

Locations
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.
  More Information

No publications provided

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT00991562     History of Changes
Other Study ID Numbers: IMGN0005
Study First Received: October 7, 2009
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmunoGen, Inc.:
relapsed or relapsed/refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on August 25, 2014