Prospective Randomized Phase II Study Evaluating Efficacy and Safety of IgPro20 as Infection Prophylaxis in Patients With Multiple Myeloma and Hypogammaglobulinemia Receiving Therapy With a Bispecific Monoclonal Antibody (BsAbs)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main purpose of this study is to see if IgPro20 can prevent infection in people with multiple myeloma (MM) who have hypogammaglobulinemia from receiving bispecific monoclonal antibodies (BsAbs).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of RRMM receiving a commercially available bispecific antibody
• Received at least 1 but no more than 4 cycles of BsAb
• Males or females greater than or equal to 18 years old at the time of consent
• ECOG ≤ 3
• Life expectancy \> 12 months
Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Mount Sinai Hospital
NOT_YET_RECRUITING
New York
Memorial Sloan Kettering Nassau (All Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Zainab Shahid, MBBS
shahidz@mskcc.org
212-639-6483
Backup
Sergio Giralt, MD
giralts@mskcc.org
646-608-3731
Time Frame
Start Date: 2025-05-08
Estimated Completion Date: 2029-05-08
Participants
Target number of participants: 100
Treatments
No_intervention: Standard of Care
Participants will only be observed
Experimental: Standard of Care + IGRT prophylaxis with IgPro20
Participants will receive IGRT prophylaxis with IgPro20 in addition to standard of care
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center