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Strategic considerations
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Celgene Corporation | INDUSTRY |
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This study will evaluate the safety and preliminary efficacy of venetoclax when combined with lenalidomide and dexamethasone for participants with newly diagnosed, active t(11;14) positive multiple myeloma (MM).
This study will consist of 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax + Lenalidomide + Dexamethasone | Experimental | Venetoclax up to 800 mg orally every day (QD) QD on Days 1 - 28 plus lenalidomide up to 25 mg orally QD on Days 1 - 21 (28 day cycle) plus dexamethasone up to 40 mg orally once weekly (QW). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venetoclax | Drug | tablet; oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participates Who Achieve CR | Complete response (CR) is defined as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow. | From baseline up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Achieve MRD Negativity | Minimal residual disease (MRD) negative after treatment is described as less than one myeloma cell per 100,000 bone marrow cells. | From baseline up to approximately 24 months |
| Percent of Participants Who Achieve VGPR or Better |
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Inclusion Criteria:
Must have documented, confirmed active multiple myeloma (MM) with greater than or equal to 10% clonal bone marrow plasma cells or biopsy-proven bone or extramedullary plasmacytoma and any one or more of the following myeloma-defining events:
Must have MM positive for the t(11;14) translocation, as determined by methods described in the protocol.
Must have measurable disease defined by at least one of the following criteria:
Newly diagnosed and not considered a candidate for high-dose therapy and hematopoietic stem cell transplantation (HSCT)
Must have Eastern Cooperative Oncology Group performance status less than or equal to 2.
Exclusion Criteria:
Has a co-existing condition as specified in the protocol.
Has history of other active malignancies, including myelodysplastic syndromes (MDS) within the past 3 years with specific exceptions detailed in the protocol.
Has been treated with or received any of the following:
Has a contraindication or inability to comply with antithrombotic prophylaxis.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope /ID# 212211 | Duarte | California | 91010 | United States | ||
| Marin Cancer Care /ID# 208476 |
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| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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| lenalidomide | Drug | capsule; oral |
|
|
| dexamethasone | Drug | tablet; oral |
|
Very Good Partial Response (VGPR) per international myeloma working group (IMWG) criteria is defined as serum or urine myeloma protein (m-protein) detectable by immunofixation but not on electrophoresis, or greater than or equal to 90% reduction in serum m-protein and urine m-protein less than 100 mg/24 hours. |
| From baseline up to approximately 24 months |
| Overall Response Rate (ORR) | ORR is described as the percentage of participants who experience partial response (PR) or better; PR per IMWG is described as follows:
| From baseline up to approximately 24 months |
| Time to Response (TTR) | Time to response is defined as the time from randomization to the first response (CR, stringent complete response [sCR], VGPR, PR). | From baseline up to approximately 24 months |
| Duration of response (DOR) | DOR is defined as the time from first observation of PR to the time of disease progression, with deaths from causes other than progression censored. | Approximately 7 years |
| Progression-free Survival (PFS) | PFS is defined as time from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first. | Approximately 7 years |
| Minimal Residual Disease (MRD) Negativity Rate at 12 Months | Percent of participants meeting the MRD Negative criteria at 12 months after initial dose; MRD Negative defined as less than one myeloma cell per 100,000 bone marrow cells. | Approximately 12 months after initial dose of study drug |
| Time to Disease Progression (TTP) | TTP is defined as the time from start of treatment to disease progression, with deaths from causes other than progression censored. | Approximately 7 years |
| Time to Next Treatment (TTNT) | The time to next treatment is defined as the time between the date of the first study drug intake and the date of the first next treatment intake after study drug discontinuation. | Approximately 7 years |
| Overall Survival (OS) Rate | OS was defined as the time from the date the participant was randomized to the date of death. | Approximately 7 years |
| Greenbrae |
| California |
| 94904 |
| United States |
| University of California, Los Angeles /ID# 208516 | Los Angeles | California | 90095 | United States |
| Karmanos Cancer Institute /ID# 208805 | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital /ID# 208481 | Detroit | Michigan | 48202 | United States |
| Duke University Hospital /ID# 208306 | Durham | North Carolina | 27710 | United States |
| UPMC Hillman Cancer Ctr /ID# 208121 | Pittsburgh | Pennsylvania | 15232 | United States |
| Westmead Hospital /ID# 210267 | Westmead | New South Wales | 2145 | Australia |
| Flinders Centre for Innovation /ID# 210697 | Bedford Park | South Australia | 5042 | Australia |
| St. Vincents Hosp Melbourne /ID# 210266 | Fitzroy | Victoria | 3065 | Australia |
| Austin Hospital /ID# 210268 | Heidelberg | Victoria | 3084 | Australia |
| Monash Medical Centre /ID# 210269 | Melbourne | Victoria | 3168 | Australia |
| Tom Baker Cancer Centre /ID# 208549 | Calgary | Alberta | T2N 4N2 | Canada |
| Princess Margaret Cancer Centr /ID# 208923 | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Maisonneuver-Rosemont /ID# 208550 | Montreal | Quebec | H1T 2M4 | Canada |
| McGill Univ HC /ID# 208486 | Montreal | Quebec | H3G 1A4 | Canada |
| Clinica Universitar de Navarra - Pamplona /ID# 209883 | Pamplona | Navarra, Comunidad | 31008 | Spain |
| Hospital Clinic de Barcelona /ID# 209888 | Barcelona | 08036 | Spain |
| Hspital Universitario Gregorio Maranon /ID# 209926 | Madrid | 28009 | Spain |
| Clinica Universitar de Navarra - Madrid /ID# 210131 | Madrid | 28021 | Spain |
| Hosp Univ 12 de Octubre /ID# 209887 | Madrid | 28041 | Spain |
| Hospital Univ Dr. Peset /ID# 209884 | Valencia | 46017 | Spain |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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