Trial · NCT00718419
A Study for Patients That Have Been Previously Been Treated in Waldenstrom's Macroglobulinemia or Multiple Myeloma
NCT00718419, Phase 2, Completed, Eli Lilly and Company; results first posted 2020-09-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study for Patients That Have Been Previously Been Treated in Waldenstrom's Macroglobulinemia or Multiple Myeloma. Trials, record NCT00718419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00718419
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Patients That Have Been Previously Been Treated in Waldenstrom's Macroglobulinemia or Multiple Myeloma
- NCT number
- NCT00718419
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Waldenstrom's Macroglobulinemia, Multiple Myeloma
- Interventions
- Enzastaurin
- First posted
- 2008-07-18
- Last updated
- 2020-09-03
- Results first posted
- 2020-09-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Response (CR), Partial Response (PR) and Minimal Response (MR) or Minor Response (MinR): (Response Rate) | 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% or \<200 mg light chain excretion (LCE), ≥50% STPC size decrease; MR: met some PR criteria plus maintain for 6 wk, a decrease of: 25-49% SPEP, 50-89% 24 hour urinary LCE, 25-49% PCBM, 25-49% STPC size. International Workshop on WM (IWWM) RC used for WM. CR: no serum M protein, malignant cells in BM, or lymphadenopathy/organomegaly; PR: ≥50% immunoglobulin M (IgM) and adenopathy/organomegaly (A/O) decrease; no new symptoms of WM. MinR: ≥25% to \<50% IgM decrease, no A/O progression; no cytopenias or clinical symptoms of WM. |
| Secondary | Duration of Response (DOR) | Time of response to time of measured progressive disease up to 38.37 months | DOR is defined as elapsed time from the first evidence of CR, PR, MR or MinR until date of progression of disease (PD). EBMT RC used for MM. CR: no serum/urine M protein for 6 wk, \<5% PCBM, no LBL size/number increase, no STPC; PR: met some CR criteria plus maintain for 6 wk ≥50% SPEP and PCBM decrease, either decrease of ≥90% or \<200 mg LCE, ≥50% STPC size decrease; MR: met some PR criteria plus maintain for 6 wk decrease of: 25-49% SPEP, 50-89% 24 hour urinary LCE, 25-49% PCBM, 25-49% STPC size. PD: \>25% increase in SPEP, 24 hour urinary LCE, PCBM, STPC size increase, new bone lesion or STPC. IWWM RC used for WM. CR: no serum M protein, malignant cells in BM, or lymphadenopathy/organomegaly; PR: ≥50% IgM and A/O decrease; no new WM symptoms. MinR: ≥25% to \<50% IgM decrease, no A/O progression; no cytopenias or clinical of WM symptoms. PD: \>25% IgM increase, progression of clinical findings or symptoms. For participants who had no PD, DOR was censored at their last contact. |
| Secondary | Time to Progressive Disease | Baseline to measured progressive disease up to 40.51 months | Time to progression is defined as the elapsed time from the date of study enrollment to the date of objectively determined progressive disease (PD). European Group for Blood and Bone Marrow Transplant (EBMT) Response Criteria was used for MM. PD: \>25% increase in serum monoclonal paraprotein (SPEP), 24 hour urinary light chain excretion (LCE), plasma cells in bone marrow (PCBM), soft tissue plasmacytomas (STPC) size increase, new bone lesion or STPC. International Workshop on WM (IWWM) Response Criteria was used for WM. PD: \>25% immunoglobulin M (IgM) increase, progression of clinical findings or symptoms. For participants who had no PD, time to PD was censored at their last contact. |
| Secondary | Number of Participants With Adverse Events (Safety and Adverse Events) | Treatment start to 30 days after discontinuation of study treatment up to 23.40 months | Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 23.40 months. |
| Other | Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment | Study treatment discontinuation up to 30 days post study treatment discontinuation |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Response (CR), Partial Response (PR) and Minimal Response (MR) or Minor Response (MinR): (Response Rate) | Baseline to measured progressive disease up to 40.51 months | All participants who received at least one dose of the study drug. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Time of response to time of measured progressive disease up to 38.37 months | All participants who received at least one dose of the study drug and had complete response (CR) or partial response (PR) or minimal response (MR) or minor response (MinR). The numbers of participants censored are 1 (MM) and 13 (WM). | months | MEDIAN |
| SECONDARY | Time to Progressive Disease | Baseline to measured progressive disease up to 40.51 months | All participants who had at least one dose of the study drug. The numbers of participants censored are 7 (MM) and 33 (WM). | months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (Safety and Adverse Events) | Treatment start to 30 days after discontinuation of study treatment up to 23.40 months | All participants who received at least one dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment | Study treatment discontinuation up to 30 days post study treatment discontinuation | All participants who received at least one dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Response (CR), Partial Response (PR) and Minimal Response (MR) or Minor Response (MinR): (Response Rate) | Multiple Myeloma (MM) | 7.1 | percentage of participants | ||
| Percentage of Participants With Complete Response (CR), Partial Response (PR) and Minimal Response (MR) or Minor Response (MinR): (Response Rate) | Waldenstrom's Macroglobulinemia (WM) | 38.1 | percentage of participants | ||
| Duration of Response (DOR) | Multiple Myeloma (MM) | NA | 95% Confidence Interval NA to NA | months | |
| Duration of Response (DOR) | Waldenstrom's Macroglobulinemia (WM) | NA | 95% Confidence Interval 17.87 to NA | months | |
| Time to Progressive Disease | Multiple Myeloma (MM) | 5.11 | 95% Confidence Interval 2.86 to NA | months | |
| Time to Progressive Disease | Waldenstrom's Macroglobulinemia (WM) | 27.73 | 95% Confidence Interval 20.47 to NA | months | |
| Number of Participants With Adverse Events (Safety and Adverse Events) | Multiple Myeloma (MM) | Serious Adverse Events | 4 | Participants | |
| Number of Participants With Adverse Events (Safety and Adverse Events) | Waldenstrom's Macroglobulinemia (WM) | Serious Adverse Events | 9 | Participants | |
| Number of Participants With Adverse Events (Safety and Adverse Events) | Multiple Myeloma (MM) | Other Nonserious Adverse Events | 12 | Participants | |
| Number of Participants With Adverse Events (Safety and Adverse Events) | Waldenstrom's Macroglobulinemia (WM) | Other Nonserious Adverse Events | 42 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Multiple Myeloma (MM) | 14 | |
| Overall Study | STARTED | Waldenstrom's Macroglobulinemia (WM) | 42 | |
| Overall Study | Received at Least One Dose of Study Drug | Multiple Myeloma (MM) | 14 | |
| Overall Study | Received at Least One Dose of Study Drug | Waldenstrom's Macroglobulinemia (WM) | 42 | |
| Overall Study | COMPLETED | Multiple Myeloma (MM) | 1 | |
| Overall Study | COMPLETED | Waldenstrom's Macroglobulinemia (WM) | 3 | |
| Overall Study | NOT COMPLETED | Multiple Myeloma (MM) | 13 | |
| Overall Study | NOT COMPLETED | Waldenstrom's Macroglobulinemia (WM) | 39 |
Source ClinicalTrials.gov
Adverse events198
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Multiple Myeloma (MM) | 6 | 14 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Waldenstrom's Macroglobulinemia (WM) | 14 | 42 | 15 |
| other | Leukopenia | Blood and lymphatic system disorders | Multiple Myeloma (MM) | 0 | 14 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Waldenstrom's Macroglobulinemia (WM) | 8 | 42 | 8 |
| other | Neutropenia | Blood and lymphatic system disorders | Multiple Myeloma (MM) | 1 | 14 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Waldenstrom's Macroglobulinemia (WM) | 6 | 42 | 6 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Multiple Myeloma (MM) | 2 | 14 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Waldenstrom's Macroglobulinemia (WM) | 6 | 42 | 7 |
| other | Vertigo | Ear and labyrinth disorders | Multiple Myeloma (MM) | 2 | 14 | 6 |
| other | Vertigo | Ear and labyrinth disorders | Waldenstrom's Macroglobulinemia (WM) | 0 | 42 | 0 |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Multiple Myeloma (MM) | ||
| Total, all-cause mortality | Waldenstrom's Macroglobulinemia (WM) | ||
| Total, other adverse events | Multiple Myeloma (MM) | 12 | 14 |
| Total, other adverse events | Waldenstrom's Macroglobulinemia (WM) | 42 | 42 |
| Total, serious adverse events | Multiple Myeloma (MM) | 4 | 14 |
| Total, serious adverse events | Waldenstrom's Macroglobulinemia (WM) | 9 | 42 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Multiple Myeloma (MM) vs Waldenstrom's Macroglobulinemia (WM): Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment | Trial comparisons |
| Multiple Myeloma (MM) vs Waldenstrom's Macroglobulinemia (WM): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00718419
GET https://conductscience.org/api/trials/v1/NCT00718419/events?page=2