NCT03490344

Short Course Daratumumab in Patients With Multiple Myeloma

Completed Phase 2 Results posted Last updated 25 May 2025

What this trial tests

Phase 2 trial testing Daratumumab in Multiple Myeloma in 10 participants. Completed in 23 March 2023.

Timeline

3 May 2018

Primary endpoint
23 March 2023

23 March 2023

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	3 May 2018
Primary completion	23 March 2023
Estimated completion	23 March 2023
Sites	7 locations across United States

Drugs / interventions tested

• Daratumumab (daratumumab) — full drug profile →
• Lenalidomide — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With MRD Negativity by the Completion of 6 Months of Daratumumab Therapy Primary · 6 months

Group	Value	95% CI
Participants With Multiple Myeloma	6
Participants With Multiple Myeloma	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With Multiple Myeloma

Serious: 3/10 (30%)

Deaths: 3/10

Serious adverse events (1 terms)

Reaction	System	Participants With Multiple…
Death NOS	General disorders	—

Most-reported serious reactions: Death NOS.

Data from ClinicalTrials.gov NCT03490344 adverse events section.

Sponsor's own description

The purpose of this study is to test the safety of short course Daratumumab in combination with lenalidomide and to find out what effects, if any, short course Daratumumab in combination with lenalidomide has on people and their risk of multiple myeloma. The study is also designed to test the amount of remaining myeloma cells in your body after treatment with daratumumab which is known as minimal residual disease (MRD).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Minimal Residual Disease in Multiple Myeloma: Current Landscape and Future Applications With Immunotherapeutic Approaches.
   Kostopoulos IV, Ntanasis-Stathopoulos I, Gavriatopoulou M, Tsitsilonis OE, et al · · 2020 · cited 42× · PMID 32537439 · DOI 10.3389/fonc.2020.00860
2. Measurable residual disease in multiple myeloma: ready for clinical practice?
   Burgos L, Puig N, Cedena MT, Mateos MV, et al · · 2020 · cited 32× · PMID 32571377 · DOI 10.1186/s13045-020-00911-4
3. Post-Transplant Maintenance Treatment Options in Multiple Myeloma.
   Karam D, Kumar S. · · 2021 · cited 8× · PMID 33615426 · DOI 10.1007/s40487-021-00143-7
4. [Chinese expert consensus on minimal residual disease detection in multiple myeloma based on bone marrow samples (2024)].
   Experimental Diagnostic Group, Plasma Cell Disease Group, Chinese Society of Hematology, Chinese Medical Association, et al · · 2024 · PMID 39134483 · DOI 10.3760/cma.j.cn121090-20240430-00167