Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
HSCT within 3 months before enrollment
Planned CAR-T therapy in the next 6 months
>1 major (deep-seated) infection within the preceding 3 months
HIV infection, Active HCV, or Active HBV infection
Trial design
Design model
Parallel
Treatments tested in this trial
IgPro20
DrugWill be administered in addition to Standard of Care treatment. IgPro20 is intended for subcutaneous administration using an infusion pump
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: Standard of Care + IGRT prophylaxis with IgPro20Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20
To compare overall infection rates amongst (RR) multiple myeloma patients with hypogammaglobulinemia receiving subcutaneous immunoglobulin (IgPro20) to those in observational arm over a 6-month period.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov