Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Carcinoma

Prostatic Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Diseases

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.

Patients receive their genomics test results both from their clinician and from the HOPE-Genomics tool. Patients then view HOPE-Genomics tool over 15-20 minutes after their results are available.

Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool.

Best Practice

View HOPE-Genomics tool after genomic test results are available

Educational Intervention

View HOPE-Genomics before sequencing results are available

Genomic Profile

Survey Administration

Stacy W Gray

This clinical trial studies the effectiveness of a web-based cancer education tool called Helping Oncology Patients Explore Genomics (HOPE-Genomics) in improving patient knowledge of personal genomic testing results and cancer and genomics in general. HOPE-Genomics is a web-based education tool that teaches cancer/leukemia patients, and patients who may be at high-risk for developing cancer, about genomic testing and provide patients with information about their own genomic test results. The HOPE-Genomics tool may improve patient's genomic knowledge and quality of patient-centered care. In addition, it may also improve education and care quality for future patients.

PRIMARY OBJECTIVES:

I. Test the efficacy of the HOPE-Genomics intervention in improving patient knowledge of genomics.

II. Test the efficacy of the HOPE-Genomics intervention in improving patient receipt of guideline-concordant care.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I (USUAL CARE): Patients receive education pamphlet about whole-genome sequencing (WES) and have their genomics test results returned by their clinician in a typical manner.

ARM II (RETURN OF RESULTS ONLY): Patients receive their genomics test results both from their clinician and from the HOPE-Genomics tool. Patients then view HOPE-Genomics tool over 15-20 minutes after their results are available.

ARM III (RETURN OF RESULTS PLUS PRE-TEST EDUCATION): Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool.

After completion of study intervention, patients are followed up at 2 weeks, 3 and 9 months after receiving genomic test results.

HOPE-Genomics Intervention for the Improvement of Cancer Patient Knowledge of Genomics

Helping Oncology Patients Explore-Genomics (HOPE-Genomics) Web Tool Randomized Clinical Trial

Patients will be assessed at 3 post-disclosure time points (T1-T3) using the Psychological Adaptation to Genetic Information Scale Certainty Scale and the Feelings About genomiC Testing Results. Will summarize test-related distress at each time point, as well as change score. Will examine baseline characteristics to evaluate the potential for bias. In addition to complete case analysis, sensitivity analyses (e.g., using weighted methods) may occur to evaluate bias. Will use clustered Wilcoxon test for mean score comparison between groups at each time point. In addition, mean change in score from T1 to T3 will be modeled using generalized estimating equation model adjusting for patient characteristics.

Will compare the pre/post test scores between the intervention group (Arm 3) and the control groups (Arms 1/2) The pre/post test scores will be calculated by taking the difference in score between pre/post tests and then comparing the mean differences with an independent T-test between control groups (Arms 1/2) versus the exclusive exposure to the HOPE-Genomics tool educational content (Arm 3).

In exploratory analyses related to Aim 2 (i.e. receipt of contextual guideline-concordant care), will also operationalize the secondary outcome in an additional way: Categories of genetically-guided care: Will evaluate patients' receipt of 1) treatment recommended by provider based on sequencing (any/none), 2) patients' sharing of sequencing results with family members (any/none), and 3) patients' consultation with genetic counseling/ recommended specialist (any/none).

Will analyze the web-log of user visits (e.g., number of viewing sessions, page views and use of interactive elements).

Recall rates of personal genomic results for Arms 2 and 3 of the study will be pooled together so that the main comparison is a two-sample test of proportions between patients under usual care (Arm 1) versus (vs.) patients with any exposure to the Helping Oncology Patients Explore (HOPE)-Genomics tool (Arms 2/3).

In the primary analysis, we will assess the uptake of contextualized guideline-concordant care taking into account clinically relevant, patient specific circumstances. Will use clinical characteristics from the electronic health record (EHR) to assign each patient to clinical category for which there are discrete National Comprehensive Cancer Network (NCCN) recommendations. Using patient self-reported baseline/T1 and EHR data, following sequencing disclosure, we will create a summary genetically-guided care variable ranging from 0-100%. In the secondary analyses, will define guideline concordant as meeting \>= 75% of recommended guidelines.

National Cancer Institute (NCI)

City of Hope Medical Center

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling using FoundationOne and an actionable target has been identified and the patient/physician agree to receive the targeted therapy

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling using FoundationOne and an actionable target has been identified. However, the patient does not receive the targeted therapy.

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling using FoundationOne and no actionable target has been identified.

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling but NOT using FoundationOne and an actionable target has been identified and the patient/physician agrees to receive the targeted therapy.

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling but NOT using FoundationOne and an actionable target has been identified. However, the patient does not receive targeted therapy.

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling but NOT using FoundationOne and an actionable target NOT has been identified.

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has not been sent for genomic profiling.

Proprietary comprehensive genomic profile.

Genomic profile by FoundationOne

Genomic profiling by other testing methods.

Genomic profile by other methods

Martin Gutierez, MD

Overall survival rates for patients with metastatic NSCLC are poor utilizing conventional cytotoxic chemotherapy approaches. However, a subset of patients harbor genomic driver mutations, which when targeted with specific therapies, experience improved outcomes.

Unfortunately, identification of these mutations, although recommended in national guidelines, has been limited for a variety of factors including small biopsy samples. The broad application of a sensitive genomic profiling test, which simultaneously examines for multiple genomic alterations on limited biopsy material, could increase the identification of patients with actionable mutations and thereby improve survival in NSCLC. The FoundationOne test meets these requirements. A recent study using the FoundationOne assay identified a significant number of actionable mutations among NSCLC patients who were previously thought to be negative for mutations when tested using other approaches.

This is a non-randomized observational comparative study with various cohorts based on physician diagnostic patterns of care and biologic genomic profile status. Survival and cost information will be compared based on different use of genomic profiling.

The understanding of NSCLC is undergoing a rapid evolution from one disease treated with empirically chosen, costly cytotoxic chemotherapies, laden with adverse effects and benefits lasting only weeks or a few months, to a rapidly growing set of genomically defined diseases that can be matched to targeted therapies with markedly improved outcomes, including response rates of 70-80% and survivals often measured in years rather than months. The need for comprehensive genomic profiling tests able to accommodate the expanding list of genomic markers without necessitating new biopsies or rising cost is not just a convenience, but a medical necessity.

In October 2014, the National Comprehensive Cancer Network (NCCN) specifically recommended that patients with metastatic NSCLC undergo "broad molecular profiling" with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials, including not only EGFR and ALK, but also BRAF, ERBB2 (HER2), MET, RET and ROS1. For example, while ERBB2 alterations are certainly more common in breast cancer, these same alterations have also been found in NSCLC and thus would predict response to targeted therapy with anti-HER2 agents. Specifically, each of these additional targetable alterations indicate a greatly increased likelihood of response to a respective targeted treatment, even though some of the treatments would be considered 'off-label' for lung cancer (e.g. trastuzumab or afatinib targeting patients with ERBB2 alterations; crizotinib for MET amplification and ROS1 rearrangements), or on-label drugs approved for lung cancer (e.g. crizotinib targeting patients with ALK rearrangements).

Problems in Genomic Testing: The substantial increase in the number of recommended targetable alterations in NSCLC presents multiple clinical and logistic challenges to the current model of gene-by-gene testing. These include non-validated testing, missed alterations that could have been matched to targeted therapy, insufficient tissue due to sequential or parallel testing, unacceptably long turnaround times, and physician frustration and confusion related to delays in obtaining all needed results and complex interpretation of multiple reports. Based on recent publications, it is reasonable to anticipate the list of targetable alterations that should be evaluated as 'standard of care' will only continue to expand. This reality makes the current model of individual tests in a gene-by-gene model unsustainable. For example traditional testing would require multiple modalities, including polymerase chain reaction (PCR)-based tests, capillary sequencing, fluorescence in situ hybridization (FISH)-based testing, and mass spectrometry-based sizing assays. Insufficient tissue to supply all of these tests is a particular problem. Traditional pathologic evaluation, including testing for the seven targetable alterations in the NCCN guidelines, may require more than 26 slides -- a tissue requirement that is usually beyond the amount obtained from minimally invasive biopsies. Competing demands for scarce tissue may place clinicians in an uncomfortable position of having to guess which tests to run when slides are running out, or alternatively, to consider conducting additional biopsy procedures. These challenges will only grow in complexity as biopsies become less invasive, the number of molecular markers and targeted therapeutic options increase, and evidence for newer markers becomes stronger.

FoundationOne is a comprehensive genomic profile that applies next generation sequencing in a unique manner to identify all 4 types of genomic alterations across all genes known to be unambiguous drivers of solid tumors with high accuracy. The test simultaneously sequences the coding region of 315 cancer-related genes plus introns from 28 genes often rearranged or altered in cancer to a typical median depth of coverage of greater than 500X. Each covered read represents a unique DNA fragment to enable the highly sensitive and specific detection of genomic alterations that occur at low frequencies due to tumor heterogeneity, low tumor purity and small tissue samples. FoundationOne detects all classes of genomic alterations, including base substitutions, insertions and deletions (indels), copy number alterations (CNAs) and rearrangements using a small, routine FFPE sample (including core or fine needle biopsies).

Foundation Medicine recently collaborated with Memorial Sloan-Kettering Cancer Center (MSKCC) to evaluate the clinical utility of this approach. After appropriate institutional approvals, a group of patients with advanced NSCLC who had completed in-house clinical testing in the CLIA-accredited MSKCC lab and who tested negative for all using conventional diagnostics, and who were alive and receiving systemic cytotoxic chemotherapy were identified. Before they were tested using FoundationOne, 24 of the first 34 such patients had required additional biopsies to complete the initial requisite testing. In 9 of the 34 clinical cases, FoundationOne could not be performed due to lack of available tissue after the initial rounds of MSKCC testing. FoundationOne was successfully performed in 25 patients uncovering one or more genomic alterations linked to a targeted agent based on NCCN guidelines in 36% (9/25 cases) and a targeted agent available on an open clinical trial at MSKCC in 32% (8/25) of patients. This approach simultaneously analyzes the multiple genes and classes of genomic alteration required for clinical care and are readily adapted to efficiently incorporate a rapidly expanding landscape of targetable alterations.

Study Design: This is a non-randomized observational comparative study with various cohorts based on physician diagnostic patterns of care and biologic genomic profile status.

Treatment of Subjects

1. All eligible patients (consecutive) with stage IV non-small cell lung cancer treated at a COTA center will be enrolled and followed on this observational study.
2. All physicians at COTA centers will be reminded that genomic profiling of non-small cell lung cancer is technically possible and in some circumstances recommended per national guidelines. For those patients who have Horizon Blue Cross insurance the physician will also be informed that the FoundationOne genomic profile will be a financially covered test. It however will be the physician's independent choice whether to order diagnostic testing and/or where this testing will be performed, without influence of the protocol study team.
3. If performed, the results of genomic profiling of the lung cancer specimen will be recorded in the COTA database, regardless of type or site of testing.
4. Treatment of the patient will be at the sole discretion of the physician. Time to initiation of therapy from the first oncology visit, and from the time of biopsy will be recorded. Time from biopsy to receipt of genomic profiling will also be recorded.
5. If a mutation in EGFR or an ALK rearrangement is identified the physician will be encouraged to treat the patient with the approved targeted agent per current national guidelines. If a ROS fusion is identified the physician will also be encouraged to consider off label use of an approved targeted therapy (ie, crizotinib).

6 If an "actionable" mutation is identified that does not have an approved targeted therapy the physician will be notified of any available research trials that might be considered. However, the decision to utilize a specific agent will be at the sole discretion of the treating physician. To expand the opportunities to offer targeted therapies, participating COTA centers will be encouraged to open national trials in lung cancer. The COTA protocol team will meet with individual centers to assist in research start-up if desired. Eligibility and participation in targeted therapy trials will be per the individual protocols. Consent for study participation will be separate from this protocol.

7 At the sole discretion of the treating physician the patient may be treated with chemotherapy, radiotherapy, surgery or other means. Consent for these treatments will be obtained by the treatment team, separate from this observational study, in accordance with policies and procedures of the treating center.

8 Patients will be allocated into one of seven cohorts based on the physicians choice of genomic profiling use 9 All patients will be tracked using the COTA database using the standard collection fields for lung cancer, including but not limited to demographics, smoking history, treatments and toxicities, and survival outcomes.

10 All patients will complete ECOG performance scores at a minimum of monthly per usual protocols at each center.

11 All patients will complete the patient reported Living with Cancer (LWC) instrument at the time of diagnosis and monthly thereafter .

Response Assessments and Planned Analyses

1. The primary endpoint is related to overall survival. All subjects will be followed for overall survival. Date of death will be recorded in the COTA database.
2. The primary endpoints will be the overall survival duration (median) and the 2 year survival rates for patients within the following cohorts: Cohorts A+B+C versus Cohorts D+E+F+G (patients undergoing FoundationOne assay testing vs not undergoing testing) The analysis will be performed for the entire study population and separately for the non-squamous cell lung cancer histologies.
3. The key secondary endpoints will be the overall survival duration (median) and the 2 year survival rates for patients within the following cohorts (additional comparisons may be performed including repeat analysis in the non-squamous histologies): Cohorts A vs B vs C vs D vs E vs F vs G Cohorts A+D versus Cohorts B+C+E+F+G (patients with actionable mutations receiving targeted therapies vs those not) Cohorts A+B+D+E versus Cohorts C+F+G (patients with actionable mutations regardless of treatment vs those without targets) Cohorts A+B+C+D+E+F versus Cohort G (patients undergoing testing vs not undergoing testing) Cohort A versus Cohorts B+C+D+E+F+G (patients receiving targeted therapy based on FoundationOne assay testing vs not)
4. Frequency of genomic mutations as documented by FoundationOne assay or any other molecular profiling will be recorded
5. A secondary endpoint will be to determine whether the identification of actionable genomic mutations is increased with the FoundationOne assay versus other methodologies. The retrospective RCCA rate of mutational identification was 22% using non-Foundation Medicine testing. In addition to this (and other historical comparisons) a comparison of the identified mutation rate in Cohorts A+B+C vs Cohorts D+E+F will be performed. The analysis will be performed in the entire cohort and the non-squamous histologies.
6. Total cost of care will be obtained via COTA sources as available.
7. A secondary endpoint will be to determine whether the use of the FoundationOne test impacts total costs. Several comparisons will be performed including a comparison of Cohorts A+B+C vs D+E+F+G (FM vs not), a comparison of A+B+C vs D+E+F (FM vs other genomic testing), a comparison of A+D vs B+C+E+F+G (targeted therapy used vs not)
8. Dosing of medications and toxicities will be recorded as per COTA standards
9. Quality of Life Analyses will be performed

Genomic Profiling in Previously Untreated Metastatic Non-small Cell Lung Cancer

A Prospective Observational Study of Comprehensive Genomic Profiling in Previously Untreated Metastatic Non-small Cell Lung Cancer

Comparison by cohorts. The "LWC" Metric has been established and validated by COTA

Regional Cancer Care Associates LLC

Foundation Medicine

Horizon Blue Cross Blue Shield of New Jersey

Cota Inc.

Symptoms and General Pathology

Recurrence

Participants receive usual care. This consists of physicians ordering GTT for patients and reviewing the results without the GTB being involved.

Patients and physicians receive the EGTB intervention. This is comprised of 2 components: the structured GTB and the supporting education. Physicians submit cases for discussion to the GTB within 2 weeks of GTT results. The GTB sessions are held weekly and conducted virtually over a video-conferencing platform. Each case presentation is 10 to 15 minutes long, and 4 to 6 cases are discussed during each 60 minute GTB session. GTT results and clinical data are presented and expert interpretation of genomic test results is provided to help prioritize potential treatment options and provide a framework for interpretation. Supporting education materials are also available online to participants to support GTT decision making.

Chart Abstraction

Physicians access genomic testing education materials

Interview

Questionnaire Administration

Patients undergo genomic tumor board review

Tumor Board Review

Patricia O'Kane

Dana Sparks

Site Public Contact

Shahzad Siddique

Catherine A. Ronaghan

Jami A. Fukui

John M. Schallenkamp

Bryan A. Faller

Vamsi K. Vasireddy

Joshua Lukenbill

Gary C. Doolittle

Rose A. Juhasz

Bret E. Friday

Pamala A. Pawloski

Jay W. Carlson

Charles S. Kuzma

Michael Humeniuk

Francis J. Cuevas

Luis J. Santos Reyes

Jens Rueter

This clinical trial studies how well an educationally enhanced genomic tumor board (EGTB) intervention works to increase the number of patients with solid tumors that have come back (recurrent), do not respond to treatment (refractory), have spread to other parts of the body (metastatic), or are newly diagnosed and spread to other parts of the body (advanced) who receive genome-informed treatment. Genome-informed treatment refers to treatment based on the information found in genomic tumor test results. This study compares the usual approach to reviewing genomic tumor test results with the approach of having a genomic tumor board (GTB) review the test results. A GTB is team of doctors and scientists that have experience in understanding genomic changes and review genomic tumor test results. The tumor board helps to suggest whether there are other cancer treatment options based on patient genetic test results. The usual approach is to review genomic tumor test results without the GTB being involved. This study may help researchers learn if using a GTB enhances the treatment decision making process within 6 months of joining the study. This study may also help researchers learn if using the GTB increases doctors' understanding of genomic tumor test results and increases doctors' comfort level with genomic tumor tests.

PRIMARY OBJECTIVE:

I. To determine whether an EGTB intervention compared to usual practice increases the proportion of patients who receive evidence-based genome-informed therapy within 6 months after registration to the study.

SECONDARY OBJECTIVES:

I. To compare physician genomic confidence and physician experience with genomic tumor testing (GTT) between arms at baseline and end of study.

II. To compare clinical outcomes between arms by assessing patient survival and time to treatment discontinuation.

III. To compare physician assessment of evidence-based genome-informed therapy to the central study team determination of evidence-based genome-informed therapy, both overall and separately by arm.

IMPLEMENTATION OBJECTIVES:

I. To assess the utilization of GTT and implementation of the EGTB intervention into clinic workflow in order to better understand barriers and facilitators at Recruitment Centers assigned to the active intervention arm using a mixed-methods approach.

II. To assess the evolution of GTT utilization within clinic workflows at recruitment centers assigned to the usual practice (control) arm using a mixed-methods approach.

OUTLINE: Study clinics are randomized to 1 of 2 arms. Participants receive interventions based on this randomization.

ARM 1: Participants receive usual care. This consists of physicians ordering GTT for patients and reviewing the results without the GTB being involved.

ARM 2: Patients and physicians receive the EGTB intervention. This is comprised of 2 components: the structured GTB and the supporting education. Physicians submit cases for discussion to the GTB within 2 weeks of GTT results. The GTB sessions are held weekly and conducted virtually over a video-conferencing platform. Each case presentation is 10 to 15 minutes long, and 4 to 6 cases are discussed during each 60 minute GTB session. GTT results and clinical data are presented and expert interpretation of genomic test results is provided to help prioritize potential treatment options and provide a framework for interpretation. Supporting education materials are also available online to participants to support GTT decision making.

Physicians are followed until the end of the study or through 6 months after their last patient was registered to the study, whichever is later. Patients are followed for 24 months after registration or until a criterion for removal from protocol participation is met, whichever comes first.

Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment

A Cluster Randomized Trial Comparing an Educationally Enhanced Genomic Tumor Board (EGTB) Intervention to Usual Practice to Increase Evidence-Based Genome-Informed Therapy

Evidence-based genome-informed therapy is defined as the use of a treatment that targets a genomic variant for which there is sufficient data to support actionability. This is a patient-specific measure determined through blinded central review of patient data, following the schemas in the protocol. An independent panel of investigators blinded to the study arm assignment of the study participant will evaluate redacted data from each subject for determination of the primary endpoint. Data supporting the primary endpoint are obtained from the genomic tumor test results PDF, pathology report, primary tumor type, and the S2108CD Treatment Form as well as curated evidence plus evidence level (tier) designation from the Jackson Labs Clinical Knowledge Base.

Measured by 3-item scale assessing physician confidence in genomic knowledge and ability to explain genomic concepts/make treatment recommendations. This assessment is on the S2108CD Genomic Testing Questionnaire.

The physician experience using genomic tumor testing in practice will be assessed using selected items from the National Survey of Precision Medicine in Cancer Treatment, included on the S2108CD Genomic Testing Questionnaire.

Overall survival on study will be measured from registration until death due to any cause.

Overall survival on new anticancer therapy will be measured from the time new anticancer therapy is initiated on study until death due to any cause.

Time to treatment discontinuation on study will be measured as the time from registration until the last dose recorded or death.

time to treatment discontinuation on new anticancer therapy will be measured as the time from registration until the last dose recorded or death.

SWOG Cancer Research Network

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Amino Acids

Dexamethasone

Venetoclax

Daratumumab

Pomalidomide

Dexamethasone acetate

Ixazomib

Thalidomide

BB 1101

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Glycine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Immunosuppressive Agents

Anti-Bacterial Agents

Neurotransmitter Agents

Patients with CDK activating alteration receive Abemaciclib in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Patients with IDH2 activating mutation receive Enasidenib in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Patients with the presence of RAF/RAS mutation receive Cobimetinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Patients with presence of FGFR3 activating mutations receive Erdafitinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Patients with t(11;14) translocation will be enrolled in arm E1 and randomized to the venetoclax or the IPd control arm. Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.

Patients with Non-Actionable Genetic Abnormality receive Daratumumab in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Patients with Non-Actionable Genetic Abnormality receive Belantamab mafodotin in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Patients with Non-Actionable Genetic Abnormality receive Selinexor in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Patients with relapsed Multiple Myeloma will receive Abemaciclib and Dexamethasone for the first 2 cycles. Abemaciclib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.

Abemaciclib, dexamethasone, ixazomib, pomalidomide

Patients with relapsed Multiple Myeloma will receive Enasidenib and Dexamethasone for the first 2 cycles. Enasidenib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.

Enasidenib, dexamethasone, ixazomib, pomalidomide

Patients with relapsed Multiple Myeloma will receive Cobimetinib and Dexamethasone for the first 2 cycles. Cobimetinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.

Cobimetinib, dexamethasone, ixazomib, pomalidomide

Patients with relapsed Multiple Myeloma will receive Erdafitinib and Dexamethasone for the first 2 cycles. Erdafitinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.

Erdafitinib, dexamethasone, ixazomib, pomalidomide

Venetoclax, dexamethasone, ixazomib, pomalidomide

Patients with relapsed Multiple Myeloma will receive Daratumumab, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.

Daratumumab, dexamethasone, ixazomib, pomalidomide

Patients with relapsed Multiple Myeloma will receive Belantamab mafodotin, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.

Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide

Patients with relapsed Multiple Myeloma will receive Selinexor, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HOPE-Genomics Intervention for the Improvement of Cancer Patient Knowledge of Genomics	NCT04905082	Breast Carcinom... Colorectal Carc... Lung Carcinoma Malignant Solid... Ovarian Carcino... Pancreatic Carc... Prostate Carcin...	Best Practice Educational Int... Educational Int... Genomic Profile Survey Administ...	18 Years -	City of Hope Medical Center
Genomic Profiling in Previously Untreated Metastatic Non-small Cell Lung Cancer	NCT02671045	Carcinoma, Non-...	Genomic profile... Genomic profile...	18 Years -	Cota Inc.
Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment	NCT05455606	Advanced Malign... Metastatic Mali... Recurrent Malig... Refractory Mali...	Best Practice Chart Abstracti... Educational Int... Genomic Profile Interview Questionnaire A... Tumor Board Rev...	18 Years -	SWOG Cancer Research Network
Myeloma-Developing Regimens Using Genomics (MyDRUG)	NCT03732703	Relapsed Refrac...	Abemaciclib, de... Enasidenib, dex... Cobimetinib, de... Erdafitinib, de... Venetoclax, dex... Daratumumab, de... Belantamab mafo... Selinexor, dexa...	18 Years -	Multiple Myeloma Research Consortium
Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment	NCT05455606	Advanced Malign... Metastatic Mali... Recurrent Malig... Refractory Mali...	Best Practice Chart Abstracti... Educational Int... Genomic Profile Interview Questionnaire A... Tumor Board Rev...	18 Years -	SWOG Cancer Research Network

Spots Global Cancer Trial Database for genomic profile