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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL069294-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Blood and Marrow Transplant Clinical Trials Network | NETWORK |
| National Cancer Institute (NCI) | NIH |
| National Marrow Donor Program | OTHER |
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This study is designed to compare long-term outcomes among patients randomized on the BMT CTN 0702 protocol (NCT01109004), "A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma". It is hypothesized that use of novel anti-myeloma agents will improve long-term progression-free survival (PFS) after high-dose melphalan followed by autologous hematopoietic cell transplantation (HCT) as compared to a second autologous transplantation.
This study is designed to compare long-term outcomes among patients randomized on the BMT CTN 0702 protocol (NCT01109004). All patients who consent will be followed for death, progression, Second Primary Malignancies (SPMs), and Quality of Life (QOL). Patients who do not consent to the long-term follow-up mechanism or who have experienced progression on the BMT CTN 0702 study will be followed through the standard Center for International Blood and Marrow Transplant Research (CIBMTR) long-term follow-up mechanism. Additionally, patients who are eligible and are willing to continue with lenalidomide as maintenance therapy will be provided lenalidomide free of charge. These patients will continue to receive lenalidomide as maintenance therapy until disease progression or discontinuation due to toxicity, death, or withdrawal from the study. The endpoints assessed will include progression-free survival (PFS), overall survival (OS), event-free survival (EFS), incidence of second primary malignancies (SPM) and health quality of life (QOL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tandem Auto Transplant | Active Comparator | Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance |
|
| RVD Consolidation | Active Comparator | Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance |
|
| Lenalidomide Maintenance | Active Comparator | Initial autologous transplant followed by lenalidomide maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression-free Survival (PFS) | This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). 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, the Kaplan-Meier estimator was used to estimate progression-free survival during the 5 year post-randomization follow-up period. | 5 years post-randomization in BMT CTN 0702 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Survival (OS) | This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Overall survival is defined as survival of death from any cause. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate overall survival during the 5 year post-randomization follow-up period. |
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Inclusion Criteria:
Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:
Inclusion Criteria for Optional Long-term Lenalidomide Maintenance Therapy:
Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data AND receive long-term lenalidomide maintenance therapy as part of this study:
Exclusion Criteria:
Patients who meet any of the following criteria will be ineligible to receive long-term lenalidomide maintenance therapy as part of this study:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Horowitz, MD | Center for International Blood and Marrow Transplant Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States | ||
| City of Hope National Medical Center |
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| Label | URL |
|---|---|
| National Marrow Donor Program | View source |
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Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).
Within 6 months of official study closure at participating sites.
Available to the public
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| ID | Title | Description |
|---|---|---|
| FG000 | Tandem Auto Transplant | Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2016 | Feb 12, 2020 |
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|
|
| 5 years post-randomization in BMT CTN 0702 |
| Percentage of Participants With Event-free Survival (EFS) | This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Event-free survival is defined as survival without disease progression, second primary malignancy, and death. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate event-free survival during the 5 year post-randomization follow-up period. | 5 years post-randomization in BMT CTN 0702 |
| Percentage of Participants With Secondary Primary Malignancies (SPM) | This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). SPM is defined as development of any second malignancy, excluding non-melanoma skin cancers. To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of SPM during the 5 year post-randomization follow-up period. The development of any SPMs excludes non-melanoma skin cancers. Death without SPMs will be considered a competing risk for this event. The cumulative incidence of SPMs will be compared between treatment arms. | 5 years post-randomization in BMT CTN 0702 |
| Percentage of Participants With Disease Progression | This analysis includes all randomized subjects from BMT CTN 0702, classified by their treatment assignment (intention-to-treat). Disease progression is defined as progression of multiple myeloma, including one or more of the following:
To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of progression during the follow-up period. | 5 years post-randomization in BMT CTN 0702 |
| Duarte |
| California |
| 91010-3000 |
| United States |
| University of California, San Diego Medical Center | La Jolla | California | 92093 | United States |
| Stanford Hospital and Clinics | Stanford | California | 94305 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
| University of Miami | Miami | Florida | 33624 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33624 | United States |
| BMT Group of Georgia (Northside Hospital) | Atlanta | Georgia | 30342 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Louisiana State University Health Sciences Center | Shreveport | Louisiana | 71130 | United States |
| DFCI, Brigham and Womens Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48105-2967 | United States |
| Karmanos Cancer Institute/BMT | Detroit | Michigan | 48201 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Washington University, Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Roswell Park Cancer Center | Buffalo | New York | 14263 | United States |
| North Shore University Hospital | Lake Success | New York | 11042 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10174 | United States |
| University of North Carolina Hospital at Chapel Hill | Chapel Hill | North Carolina | 27599-7305 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Jewish Hospital BMT Program | Cincinnati | Ohio | 45236 | United States |
| University Hospitals of Cleveland/Case Western | Cleveland | Ohio | 44106-5061 | United States |
| Ohio State/Arthur G. James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| University of Oklahoma Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239-3098 | United States |
| Penn State College of Medicine, The Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Blood & Marrow Transplant Program | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-8210 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Texas/MD Anderson CRC | Houston | Texas | 77030 | United States |
| Texas Transplant Institute | San Antonio | Texas | 78229 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | United States |
| University of Wisconsin Hospital & Clinics | Madison | Wisconsin | 53792-5156 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53211 | United States |
| FG001 | RVD Consolidation | Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
| FG002 | Lenalidomide Maintenance | Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tandem Auto Transplant | Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
| BG001 | RVD Consolidation | Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
| BG002 | Lenalidomide Maintenance | Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Karnofsky Performance Score (KPS) | KPS describes patient-perceived global quality of life and functioning on a scale of 0-100. 100: No evidence of disease; 90: Normal activity. Minor signs or symptoms of disease; 80: Normal activity with effort. Some signs or symptoms of disease; 70: Cares for self. Unable to continue normal activity; 60: Needs occasional assistance, but cares for most personal needs; 50: Needs considerable assistance and medical care; 40: Disabled. Needs special care and assistance; 30: Severely disabled. Hospital admission indicated; 20: Very sick. Active supportive therapy needed; 10: Moribund; 0: Dead | Count of Participants | Participants |
| |||||||||||||||
| Diseae Risk at BMT CTN 0702 Enrollment | Participants on this study will be stratified for the purposes of statistical analysis into high-risk and standard risk-groups. High-risk multiple myeloma is defined by the presence of high beta-2 microglobulin (> 5.5mg/L) or the presence of cytogenetic abnormalities including t(4;14), t(14;20), t(14;16), deletion (17p) detected by FISH or standard cytogenetics, deletion 13 detected by standard cytogenetics only or aneuploidy. Participants without cytogenetic analysis available and beta-2 microglobulin ≤ 5.5mg/L or with deletion 13 detected by FISH will be classified as standard-risk disease. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Progression-free Survival (PFS) | This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). 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, the Kaplan-Meier estimator was used to estimate progression-free survival during the 5 year post-randomization follow-up period. | All 754 randomized BMT CTN 0702 participants are included in this analysis | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post-randomization in BMT CTN 0702 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Survival (OS) | This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Overall survival is defined as survival of death from any cause. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate overall survival during the 5 year post-randomization follow-up period. | All 754 randomized BMT CTN 0702 participants are included in this analysis | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post-randomization in BMT CTN 0702 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Event-free Survival (EFS) | This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Event-free survival is defined as survival without disease progression, second primary malignancy, and death. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate event-free survival during the 5 year post-randomization follow-up period. | All 754 randomized BMT CTN 0702 participants are included in this analysis | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post-randomization in BMT CTN 0702 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Secondary Primary Malignancies (SPM) | This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). SPM is defined as development of any second malignancy, excluding non-melanoma skin cancers. To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of SPM during the 5 year post-randomization follow-up period. The development of any SPMs excludes non-melanoma skin cancers. Death without SPMs will be considered a competing risk for this event. The cumulative incidence of SPMs will be compared between treatment arms. | All 754 randomized BMT CTN 0702 participants are included in this analysis | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post-randomization in BMT CTN 0702 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Disease Progression | This analysis includes all randomized subjects from BMT CTN 0702, classified by their treatment assignment (intention-to-treat). Disease progression is defined as progression of multiple myeloma, including one or more of the following:
To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of progression during the follow-up period. | All 754 randomized BMT CTN 0702 participants are included in this analysis | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post-randomization in BMT CTN 0702 |
|
22 months post-enrollment to BMT CTN 07LT
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tandem Auto Transplant | Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. | 4 | 98 | 6 | 98 | 0 | 98 |
| EG001 | RVD Consolidation | Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. | 4 | 86 | 10 | 86 | 0 | 86 |
| EG002 | Lenalidomide Maintenance | Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. | 2 | 89 | 6 | 89 | 0 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Acute promyelocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| B precursor type acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| B-cell type acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Mendizabal, PhD | The Emmes Company | 301-251-1161 | amendizabal@emmes.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2019 | Feb 12, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D018450 | Disease Progression |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| White |
|
| Multiracial |
|
| Other |
|
| Unknown or Not Reported |
|
| 70-80 |
|
| High |
|
| The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy. | Log Rank | The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk) | 0.35 | The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3. | Superiority |
| The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy. | Log Rank | The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk) | 0.68 | The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3. | Superiority |
| OG002 | Lenalidomide Maintenance | Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
|
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| OG002 | Lenalidomide Maintenance | Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
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| RVD Consolidation |
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
| OG002 | Lenalidomide Maintenance | Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
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| OG001 | RVD Consolidation | Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
| OG002 | Lenalidomide Maintenance | Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study. |
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