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NCT00718419
An Open Label, Multicenter Phase 2 Study of Single-Agent Enzastaurin HCl in Previously Treated Waldenstrom's Macroglobulinemia or Multiple Myeloma
Phase 2 trial testing Enzastaurin in Waldenstrom's Macroglobulinemia in 56 participants. Completed in 1 August 2012.
1 September 2010
Quick facts
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 1 July 2008 |
| Primary completion | 1 September 2010 |
| Estimated completion | 1 August 2012 |
| Sites | 4 locations across United States, France |
Drugs / interventions tested
- Enzastaurin — full drug profile →
Conditions studied
- Waldenstrom's Macroglobulinemia — all drugs for Waldenstrom's Macroglobulinemia →
- Multiple Myeloma — all drugs for Multiple Myeloma →
Sponsor
Eli Lilly and Company — full company profile →
Who can join
18 and older, any sex, with Waldenstrom's Macroglobulinemia or Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Minimal Response (MR) or Minor Response (MinR): (Response Rate)
Time frame: Baseline to measured progressive disease up to 40.51 months
European Group for Blood and Bone Marrow Transplant (EBMT) Response Criteria (RC) used for MM. CR: no serum/urine M protein for 6 weeks (wk), \<5% plasma cells in bone marrow (PCBM), no lytic bone lesions (LBL) size/number increase, no soft tissue plasmacytomas (STPC); PR: met some CR criteria plus maintain for 6 wk ≥50% serum monoclonal paraprotein (SPEP) and PCBM decrease, either decrease of ≥90
Sponsor's own description
To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated Waldenstrom's Macroglobulinemia or Multiple Myeloma based on response.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
p73 as a pharmaceutical target for cancer therapy.
Bisso A, Collavin L, Del Sal G. · · 2011 · cited 30× · PMID 21391908 · DOI 10.2174/138161211795222667 -
Kinase inhibitors as potential agents in the treatment of multiple myeloma.
Abramson HN. · · 2016 · cited 14× · PMID 27655636 · DOI 10.18632/oncotarget.10745 -
Identification of Candidate Genes and Therapeutic Agents for Light Chain Amyloidosis Based on Bioinformatics Approach.
Bai W, Wang H, Bai H. · · 2019 · cited 6× · PMID 32099441 · DOI 10.2147/pgpm.s228574
Verify or expand the search:
- PubMed search for NCT00718419
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Enzastaurin
Trials testing the same drug.
- NCT00709995 — A Study for Participants With Metastatic Renal Cell Carcinoma · Phase 2 · completed
Other recruiting trials for Waldenstrom's Macroglobulinemia
Currently open trials in the same condition.
- NCT00492050 — Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia · Phase 2 · active not recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
- NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
- NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
- NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
- NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
- NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00718419 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
- Last refreshed: 1 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00718419.
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