Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401
An Extension Study to Evaluate the Long-Term Safety, Tolerability, and Clinical Activity of IMO-8400 in Patients With Relapsed or Refractory Waldenström's Macroglobulinemia Who Completed Study 8400-401
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.
Patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (NCT02092909) will continue to receive IMO-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with IMO-8400 have been met.
Phase 1/Phase 2
Number of Participants With Adverse Events
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
Study Arms / Comparison Groups
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
Description: Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - Completed 24 weeks of treatment in Protocol 8400-401 Exclusion Criteria: - Grade 3 (or higher) adverse event assessed as treatment-related at any time during the course of treatment under Protocol 8400-401. - Has evidence of disease progression under Protocol 8400-401. - Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.
18 Years - N/A
Accepts Healthy Volunteers
Mark Cornfeld, MD, MPH, ,
Idera Pharmaceuticals, Inc.
Mark Cornfeld, MD, MPH, Study Director, Idera Pharmaceuticals, Inc.