CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Daratumumab +1 moredrug
Likely dose
Daratumumab 16mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03490344
NCT03490344Phase 2Completed
CompareCT.gov

Short Course Daratumumab in Minimal Residual Disease (MRD) Positive Myeloma Patients After Induction Therapy With/Without Consolidative High Dose Chemotherapy/Autologous Stem Cell Support

Memorial Sloan Kettering Cancer Center·interventional·Posted Apr 6, 2018·Updated May 25, 2025

In Brief

A Phase 2 clinical trial evaluating Daratumumab and Lenalidomide for Multiple Myeloma. Completed, enrolled 10 participants across 7 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsJanssen Scientific Affairs, LLC

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 6, 2018
Enrollment StartMay 3, 2018
Primary CompletionMar 23, 2023
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.2 years ago

Interventions

Daratumumabdrug

* Cycles 1 and 2: Daratumumab 16mg/kg weekly per cycle (28 days) as intravenous infusion (total duration: 8 weeks) * Cycles 3-6: Daratumumab 16mg/kg once every 2 weeks per cycle (28 days) as intravenous infusion (total duration: 16 weeks)

Lenalidomidedrug

Lenalidomide maintenance therapy to be administered as standard treatment to all participants. This is administered as 5-15 mg daily 21-28/28 day cycle.