Trial · NCT01109004
Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)
NCT01109004, Phase 3, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2018-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702). Trials, record NCT01109004. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01109004
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)
- NCT number
- NCT01109004
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 758 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Multiple Myeloma
- Interventions
- Lenalidomide, lenalidomide, bortezomib and dexamethasone, Lenalidomide
- First posted
- 2010-04-22
- Last updated
- 2021-12-09
- Results first posted
- 2018-06-11
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Progression-free Survival (PFS) | 38 months post-randomization | Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization. |
| Secondary | Percentage of Participants With Disease Progression | 38 months post-randomization | Disease Progression is defined as progression of multiple myeloma, including one or more of the following: * A reappearance of serum monoclonal paraprotein, with a level of at least 0.5 g/dL * 24-hour urine protein electrophoresis with at least 200 mg paraprotein/24 hours * Abnormal free light chain levels of \>10 mg/dl, only in patients without measurable paraprotein in the serum and urine * At least 10% plasma cells in a bone marrow aspirate or on trephine biopsy * Definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of new bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum Ca \>11.5 mg/dL or \>2.8 mmol/L) not attributable to any other cause To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating death prior to disease progression as a competing risk. |
| Secondary | Percentage of Participants With Overall Survival (OS) | 38 months post-randomization | Overall survival is defined as survival of death from any cause. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate overall survival at 38 months post-randomization. |
| Secondary | Percentage of Participants With Treatment-related Mortality (TRM) | Up to 38 months post-randomization | TRM is defined as death prior to progression of multiple myeloma. To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating disease progression as a competing risk. |
| Secondary | Number of Participants With Treatment Response | 1 and 2 years post-randomization | The number of participants with very good partial response (VGPR) or better \[complete response (CR), near CR (nCR), and stringent CR (sCR)\] according to the International Uniform Response Criteria will be calculated. The "Worse than VGPR" group includes PR, stable disease, and progressive disease. sCR requires, in addition to CR: Normal free light chain ratio (FLC), Absence of clonal cells in bone marrow CR requires, in addition to nCR: Absence of the original monoclonal paraprotein (PPN), Disappearance of soft tissue plasmacytomas nCR is defined as: \< 5% plasma cells in a bone marrow aspirate, No increase in lytic bone lesions VGPR requires: Serum or urine PPN not detectable on electrophoresis OR \>=90% reduction in serum PPN plus urine PPN \<100 mg/24hrs, \>= 50% reduction in the level of serum monoclonal PPN or reduction in 24 hour urinary monoclonal PPN either \>= 90% or to \<200 mg/24 hours in light chain disease, \>= 50% reduction in the size of soft tissue plasmacytomas |
| Secondary | FACT-G Total Score | Up to 3 years post-randomization | The Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life instrument that assesses the effects of cancer therapy on a patient's physical, social/family, emotional, and functional well-being. The assessment has 27 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-108, with higher scores indicating higher levels of overall well-being. |
| Secondary | FACT-BMT Score | Up to 3 years post-randomization | The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being. |
| Secondary | FACT-BMT Trial Outcome Index | Up to 3 years post-randomization | The Functional Assessment of Cancer Therapy (FACT) Trial Outcome Index is a quality of life instrument that assesses the impact of bone marrow transplantation (BMT) on a patient's physical and functional well-being while taking into consideration BMT-specific concerns. The assessment has 24 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-96, with higher scores indicating higher levels of overall well-being. |
| Secondary | MOS SF-36 Physical Component Summary | Up to 3 years post-randomization | The Medical Outcome Study (MOS) SF-36 Physical Component Summary is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being. |
| Secondary | MOS SF-36 Mental Component Summary | Up to 3 years post-randomization | The Medical Outcome Study (MOS) SF-36 Mental Component Summary is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being. |
Source ClinicalTrials.gov
Outcomes10
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 Progression-free Survival (PFS) | 38 months post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Disease Progression | 38 months post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Overall Survival (OS) | 38 months post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Treatment-related Mortality (TRM) | Up to 38 months post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Treatment Response | 1 and 2 years post-randomization | Only participants that were evaluable for disease response were analyzed at each time point. Those who had died or experienced disease progression were excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | FACT-G Total Score | Up to 3 years post-randomization | Outcomes are analyzed from participants that were alive, progression-free, and completed assessments. | score on a scale | MEAN |
| SECONDARY | FACT-BMT Score | Up to 3 years post-randomization | Outcomes are analyzed from participants that were alive, progression-free, and completed assessments. | score on a scale | MEAN |
| SECONDARY | FACT-BMT Trial Outcome Index | Up to 3 years post-randomization | Outcomes are analyzed from participants that were alive, progression-free, and completed assessments. | score on a scale | MEAN |
| SECONDARY | MOS SF-36 Physical Component Summary | Up to 3 years post-randomization | Outcomes are analyzed from participants that were alive, progression-free, and completed assessments. | score on a scale | MEAN |
| SECONDARY | MOS SF-36 Mental Component Summary | Up to 3 years post-randomization | Outcomes are analyzed from participants that were alive, progression-free, and completed assessments. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group90
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 Progression-free Survival (PFS) | Tandem Auto Transplant | 58.5 | 95% Confidence Interval 51.7 to 64.6 | percentage of participants | |
| Percentage of Participants With Progression-free Survival (PFS) | RVD Consolidation | 57.8 | 95% Confidence Interval 51.4 to 63.7 | percentage of participants | |
| Percentage of Participants With Progression-free Survival (PFS) | Lenalidomide Maintenance | 53.9 | 95% Confidence Interval 47.4 to 60.0 | percentage of participants | |
| Percentage of Participants With Disease Progression | Tandem Auto Transplant | 39.8 | 95% Confidence Interval 33.4 to 46.1 | percentage of participants | |
| Percentage of Participants With Disease Progression | RVD Consolidation | 41.0 | 95% Confidence Interval 34.7 to 47.0 | percentage of participants | |
| Percentage of Participants With Disease Progression | Lenalidomide Maintenance | 45.6 | 95% Confidence Interval 39.2 to 51.8 | percentage of participants | |
| Percentage of Participants With Overall Survival (OS) | Tandem Auto Transplant | 81.8 | 95% Confidence Interval 76.2 to 86.2 | percentage of participants | |
| Percentage of Participants With Overall Survival (OS) | RVD Consolidation | 85.4 | 95% Confidence Interval 80.4 to 89.3 | percentage of participants | |
| Percentage of Participants With Overall Survival (OS) | Lenalidomide Maintenance | 83.7 | 95% Confidence Interval 78.4 to 87.8 | percentage of participants | |
| Percentage of Participants With Treatment-related Mortality (TRM) | Tandem Auto Transplant | 1.7 | 95% Confidence Interval 0.6 to 4.2 | percentage of participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tandem Auto Transplant | 247 | |
| Overall Study | STARTED | RVD Consolidation | 254 | |
| Overall Study | STARTED | Lenalidomide Maintenance | 257 | |
| Overall Study | COMPLETED | Tandem Auto Transplant | 247 | |
| Overall Study | COMPLETED | RVD Consolidation | 254 | |
| Overall Study | COMPLETED | Lenalidomide Maintenance | 257 | |
| Overall Study | NOT COMPLETED | Tandem Auto Transplant | 0 | |
| Overall Study | NOT COMPLETED | RVD Consolidation | 0 | |
| Overall Study | NOT COMPLETED | Lenalidomide Maintenance | 0 |
Source ClinicalTrials.gov
Adverse events273
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 |
|---|---|---|---|---|---|---|
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | Tandem Auto Transplant | 0 | 247 | 0 |
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | RVD Consolidation | 0 | 254 | 0 |
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | Lenalidomide Maintenance | 1 | 257 | 1 |
| serious | Splenic infarction | Blood and lymphatic system disorders | Tandem Auto Transplant | 0 | 247 | 0 |
| serious | Splenic infarction | Blood and lymphatic system disorders | RVD Consolidation | 0 | 254 | 0 |
| serious | Splenic infarction | Blood and lymphatic system disorders | Lenalidomide Maintenance | 1 | 257 | 1 |
| serious | Acute myocardial infarction | Cardiac disorders | Tandem Auto Transplant | 0 | 247 | 0 |
| serious | Acute myocardial infarction | Cardiac disorders | RVD Consolidation | 0 | 254 | 0 |
| serious | Acute myocardial infarction | Cardiac disorders | Lenalidomide Maintenance | 1 | 257 | 1 |
| serious | Atrial fibrillation | Cardiac disorders | Tandem Auto Transplant | 0 | 247 | 0 |
1 to 10 of 273Source ClinicalTrials.gov
See all 273 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tandem Auto Transplant | ||
| Total, all-cause mortality | RVD Consolidation | ||
| Total, all-cause mortality | Lenalidomide Maintenance | ||
| Total, other adverse events | Tandem Auto Transplant | 0 | 247 |
| Total, other adverse events | RVD Consolidation | 0 | 254 |
| Total, other adverse events | Lenalidomide Maintenance | 0 | 257 |
| Total, serious adverse events | Tandem Auto Transplant | 42 | 247 |
| Total, serious adverse events | RVD Consolidation | 45 | 254 |
| Total, serious adverse events | Lenalidomide Maintenance | 53 | 257 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL069294 | BMT Clinical Research Network Data Coordinating Center | HOROWITZ, MARY MARESCA | MEDICAL COLLEGE OF WISCONSIN | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01109004
GET https://conductscience.org/api/trials/v1/NCT01109004/results?page=2