Drugs / Lenalidomide
Lenalidomide
DrugLenalidomide is an oral immunomodulatory imide drug (IMiD), also described as a cereblon E3 ligase modulator, used in hematologic malignancies such as multiple myeloma and selected lymphomas/MDS. It is marketed under the brand name Revlimid. U.S. approval was first granted in 2005.
- Trials
- 1097
- Recruiting
- 123
- Completed
- 498
- With results
- 371
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 2 | — | — | — | 3 | 2 | — | — | 2 | — | 9 |
| Phase 1 | 8 | 1 | — | 23 | 104 | 44 | 6 | 1 | 7 | — | 194 |
| Phase 1/2 | 16 | 4 | — | 21 | 81 | 26 | 10 | 1 | 15 | — | 174 |
| Phase 2 | 61 | 16 | 2 | 58 | 224 | 60 | 17 | — | 51 | — | 489 |
| Phase 2/3 | 3 | — | — | — | 4 | 1 | 1 | — | 2 | — | 11 |
| Phase 3 | 26 | 9 | — | 42 | 60 | 8 | 3 | — | 11 | — | 159 |
| Phase 4 | 3 | 2 | — | 1 | 5 | 2 | 2 | — | 5 | — | 20 |
| Not applicable | 2 | 1 | — | — | 5 | 2 | — | — | 3 | — | 13 |
| Unknown | 2 | — | — | 1 | 12 | 1 | — | — | 9 | 3 | 28 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Multiple Myeloma | 3 | 70 | 58 | 188 | 5 | 91 | 10 | 3 | 11 | 439 |
| Lymphoma, Large B-Cell, Diffuse | — | 14 | 25 | 42 | 1 | 11 | — | 1 | 4 | 98 |
| Leukemia, Lymphocytic, Chronic, B-Cell | — | 26 | 17 | 41 | — | 4 | — | 1 | — | 89 |
| Lymphoma, Follicular | — | 15 | 23 | 23 | — | 19 | — | — | 2 | 82 |
| Recurrence | — | 12 | 18 | 30 | 1 | 12 | — | 1 | 4 | 78 |
| Lymphoma | — | 10 | 18 | 25 | — | 7 | — | — | 2 | 62 |
| Lymphoma, Mantle-Cell | — | 16 | 14 | 23 | — | 4 | — | — | 3 | 60 |
| Neoplasms, Plasma Cell | 1 | 10 | 9 | 27 | 1 | 9 | — | 1 | 1 | 59 |
| Myelodysplastic Syndromes | — | 12 | 5 | 27 | — | 4 | 1 | — | 3 | 52 |
| Lymphoma, B-Cell, Marginal Zone | — | 13 | 12 | 15 | — | 6 | — | 1 | — | 47 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Celgene | 63 | 21 |
| 2 | M.D. Anderson Cancer Center | 60 | 0 |
| 3 | National Cancer Institute (NCI) | 57 | 8 |
| 4 | Mayo Clinic | 29 | 0 |
| 5 | Celgene Corporation | 23 | 7 |
| 6 | Memorial Sloan Kettering Cancer Center | 22 | 0 |
| 7 | Ruijin Hospital | 21 | 4 |
| 8 | Janssen Research & Development, LLC | 19 | 8 |
| 9 | Bristol-Myers Squibb | 15 | 4 |
| 10 | Dana-Farber Cancer Institute | 14 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Lenalidomide | 1097 |
| 2 | Dexamethasone | 370 |
| 3 | Rituximab | 191 |
| 4 | Bortezomib | 145 |
| 5 | Calcium Dobesilate | 109 |
| 6 | Cyclophosphamide | 107 |
| 7 | daratumumab | 99 |
| 8 | Prednisone | 76 |
| 9 | carfilzomib | 68 |
| 10 | Doxorubicin | 53 |
Evidence
- Results reported
- 74.5%371 of 498 completed
- Published
- 15.3%76 of 498 completed
- Primary endpoint met
- 42.9%39 of 91 analyses
- Median months to report
- 13
Documents disclosed
Trial profile
- Median enrollment
- 45
- Median duration
- 62months
- Countries
- 62
- Study sites
- 14730
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 21
- Phase 1
- 24
- Phase 1/2
- 47
- Phase 2
- 41
- Phase 2/3
- 100
- Phase 3
- 395
- Phase 4
- 60
- Not applicable
- 24
- Unknown
- 200
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | New York | United States | 176 |
| 2 | Houston | United States | 149 |
| 3 | Boston | United States | 128 |
| 4 | Chicago | United States | 106 |
| 5 | Rochester | United States | 106 |
| 6 | Madrid | Spain | 103 |
| 7 | Barcelona | Spain | 94 |
| 8 | Paris | France | 94 |
| 9 | Columbus | United States | 93 |
| 10 | Nantes | France | 93 |
Terminations
- Terminated
- 146
- Withdrawn
- 39
- Suspended
- 2
- Stopped for recruitment
- 5.5%60 of 1097 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT07428369 Withdrawn | Withdrawn | Sponsor Decision | 2038-05-21 |
| NCT05867030 Withdrawn | Withdrawn | Development strategy adjustment | 2033-04-30 |
| NCT06313996 Withdrawn | Withdrawn | Replaced with another clinical trial. | 2031-10-16 |
| NCT04539236 Suspended | Suspended | Funding Sponsor decision | 2029-08-01 |
| NCT06348147 Withdrawn | Withdrawn | budget | 2029-05-31 |
| NCT04882163 Withdrawn | Withdrawn | Business objectives have changed | 2029-04-07 |
| NCT05279300 Suspended | Suspended | The sponsor is temporarily pausing the trial to evaluate existing clinical data for long-term benefit-risk and optimize doses and dosing schedule. | 2027-12-31 |
| NCT05820763 Withdrawn | Withdrawn | Study sponsor decided to close study. | 2027-01-31 |
| NCT05183139 Withdrawn | Withdrawn | Business decision (no enrollment) | 2026-12-31 |
| NCT05660967 Terminated | Terminated | The study was terminated because sufficient data had been collected to meet the objectives of the development program. No new or unexpected safety findings were identified, and the decision to terminate was not related to participant safety. | 2026-06-10 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: