Trial Outcomes & Findings for Short Course Daratumumab in Patients With Multiple Myeloma (NCT NCT03490344)

Last Updated: 2025-05-25

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

6 months

Results posted on

2025-05-25

Participant milestones
Measure	Participants With Multiple Myeloma Participants with MM with very good partial response (VGPR) or better after induction therapy with/without consolidative HDT/ASCT and MRD positive by bone marrow flow cytometry and MM participants who were previously MRD negative after induction and consolidation and recently (within last 3 months) turned MRD positive by bone marrow flow cytometry will be enrolled.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Short Course Daratumumab in Patients With Multiple Myeloma

Baseline characteristics by cohort
Measure	Participants With Multiple Myeloma n=10 Participants Participants with MM with very good partial response (VGPR) or better after induction therapy with/without consolidative HDT/ASCT and MRD positive by bone marrow flow cytometry and MM participants who were previously MRD negative after induction and consolidation and recently (within last 3 months) turned MRD positive by bone marrow flow cytometry will be enrolled.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

Timeframe: 6 months

Outcome measures
Measure	Participants With Multiple Myeloma n=10 Participants Participants with MM with very good partial response (VGPR) or better after induction therapy with/without consolidative HDT/ASCT and MRD positive by bone marrow flow cytometry and MM participants who were previously MRD negative after induction and consolidation and recently (within last 3 months) turned MRD positive by bone marrow flow cytometry will be enrolled.
Number of Participants With MRD Negativity by the Completion of 6 Months of Daratumumab Therapy Conversion from MRD-negativity to MRD-positivity	6 Participants
Number of Participants With MRD Negativity by the Completion of 6 Months of Daratumumab Therapy Persistent MRD-positivity	4 Participants

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events
Measure	Participants With Multiple Myeloma n=10 participants at risk Participants with MM with very good partial response (VGPR) or better after induction therapy with/without consolidative HDT/ASCT and MRD positive by bone marrow flow cytometry and MM participants who were previously MRD negative after induction and consolidation and recently (within last 3 months) turned MRD positive by bone marrow flow cytometry will be enrolled.
General disorders Death NOS	30.0% 3/10 • Up to 1 year

Adverse event data not reported

Memorial Sloan Kettering Cancer Center

Phone: 646-608-3712