Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02076009 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 569
- Enrollment target
NCT02076009: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02076009 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 569 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02076009, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 569 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.
Primary Outcome
PFS: duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD: defined as meeting any 1 of following criteria: Increase of greater than equal to (\>=)25 percent(%) in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 gram per deciliter (g/dL); Increase of \>=25% in 24-hours(h) urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24h; Only in parti
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Daratumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 569 participants |
| Start Date | 2014-07-23 |
| Est. Completion | 2024-11-21 |
| Phase | Phase 3 |
What the finished NCT02076009 record still lists
NCT02076009 is an interventional study that assigns participants to a tested intervention. The registered 569 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT02076009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02076009 about?
NCT02076009 is a clinical study titled "A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma". The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.
What is the current status of trial NCT02076009?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 569 participants. The study started on 2014-07-23. Estimated completion is 2024-11-21.
What interventions are being tested in trial NCT02076009?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG).
Who is sponsoring clinical trial NCT02076009?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02076009's enrollment target sits among peer trials
569 666th of 2000 higher than 1,335 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05000645 · 570 participants · NA
Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
- NCT06239844 · 570 participants · NA
Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
- NCT06701903 · 570 participants · Phase 2
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
- NCT07266831 · 570 participants · Phase 2
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI