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An Open-Label Phase I Study of BB-10901 (IMGN901, huN901-DM1) in Combination with Lenalidomide and Dexamethasone in Patients with CD56- positive Relapsed or Relapsed/Refractory Multiple Myeloma

Study Status

Open to Enrollment

Study Description

The purpose of this study is to:

• Test the safety and anti-tumor effect of the experimental drug BB-10901 when given with lenalidomide and dexamethasone
• Help determine the highest dose of BB-10901 that can be safely given without causing serious side effects when you are also receiving treatment with lenalidomide and dexamethasone
• See if the combination of BB-10901, lenalidomide and dexamethasone will help treat your cancer and prevent your cancer from getting worse

BB-10901 is believed to work by binding to a molecule on the surface of multiple myeloma cells called CD56. Once the BB-10901 binds to the CD56, it releases a potent cell-killing drug called maytansinoid into the cancer cell.  BB-10901 has been shown to cause cancer cells to die when grown in culture dishes or in laboratory mice. It has been studied alone in people with other types of cancer, and some tumor shrinkage was noted in a limited number of patients.

Participants in this study will be assigned to take different amounts of BB-10901 with fixed amounts of lenalidomide and dexamethasone to help find the highest safe dose of BB-10901. Patients will be closely monitored for evidence of dose limiting toxicity.

Sponsor

ImmunoGen, Inc.

Key Eligibility

• Men and women age 18 and older
• CD56-positive, relapsed or relapsed/refractory multiple myeloma
• At least one prior therapy for multiple myeloma
• Detailed eligibility reviewed when you contact the study team

Principal Investigator

Ruben Niesvizky, MD

Contact

• Patrice Mignott
• (212) 746-1480