NCT03937635

Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma

Recruiting now Phase 3 Last updated 3 April 2026

What this trial tests

Phase 3 trial testing Daratumumab in Smoldering Plasma Cell Myeloma in 288 participants. Currently enrolling.

Timeline

16 September 2019

Primary endpoint
31 December 2029

31 December 2029

Quick facts

Lead sponsor	ECOG-ACRIN Cancer Research Group
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	288
Start date	16 September 2019
Primary completion	31 December 2029
Estimated completion	31 December 2029
Sites	707 locations across Puerto Rico, United States

Drugs / interventions tested

• Daratumumab (daratumumab) — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →
• Lenalidomide — full drug profile →
• Quality-of-Life Assessment
• Questionnaire Administration

Conditions studied

• Smoldering Plasma Cell Myeloma — all drugs for Smoldering Plasma Cell Myeloma →

Sponsor

ECOG-ACRIN Cancer Research Group

Who can join

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

Sponsor's own description

This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.

Publications & conference data

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

1. Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma.
   Lonial S, Jacobus S, Fonseca R, Weiss M, et al · · 2020 · cited 222× · PMID 31652094 · DOI 10.1200/jco.19.01740
2. Harnessing natural killer cells for cancer immunotherapy: dispatching the first responders.
   Maskalenko NA, Zhigarev D, Campbell KS. · · 2022 · cited 174× · PMID 35314852 · DOI 10.1038/s41573-022-00413-7
3. Endothelial cells in tumor microenvironment: insights and perspectives.
   Leone P, Malerba E, Susca N, Favoino E, et al · · 2024 · cited 90× · PMID 38426109 · DOI 10.3389/fimmu.2024.1367875
4. Smoldering multiple myeloma current treatment algorithms.
   Rajkumar SV, Kumar S, Lonial S, Mateos MV. · · 2022 · cited 49× · PMID 36064707 · DOI 10.1038/s41408-022-00719-0
5. Drug resistance in multiple myeloma: Soldiers and weapons in the bone marrow niche.
   Solimando AG, Malerba E, Leone P, Prete M, et al · · 2022 · cited 37× · PMID 36212502 · DOI 10.3389/fonc.2022.973836
6. Evaluating Daratumumab in the Treatment of Multiple Myeloma: Safety, Efficacy and Place in Therapy.
   Dima D, Dower J, Comenzo RL, Varga C. · · 2020 · cited 36× · PMID 32904669 · DOI 10.2147/cmar.s212526
7. The Immune Regulatory Role of Adenosine in the Tumor Microenvironment.
   Xing J, Zhang J, Wang J. · · 2023 · cited 34× · PMID 37834375 · DOI 10.3390/ijms241914928
8. Pursuing a Curative Approach in Multiple Myeloma: A Review of New Therapeutic Strategies.
   D'Agostino M, Bertamini L, Oliva S, Boccadoro M, et al · · 2019 · cited 32× · PMID 31847174 · DOI 10.3390/cancers11122015