Relapsed Multiple MyelomaPhase 2ESdRRMMNCT05170789
Elotuzumab, Selinexor, and Dexamethasone for Relapsed Refractory Multiple Myeloma
A Phase 2 study testing Elotuzumab, Selinexor, and Dexamethasone (ESd) in people with Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by Tulane University School of Medicine.
Trial summary
The food and drug administration (FDA) has approved the use of Selinexor, an oral, first-in class, exportin 1 (XPO1) inhibitor, in combination with low-dose dexamethasone in patients with triple-refractory (disease refractory to proteasome inhibitors (PI), immunomodulatory imid agents (IMiD), and anti-Cluster of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- Elotuzumab, Selinexor, and Dexamethasone (ESd)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2022to 27 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
- Age ≥ 18 years
- Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 2
- Having measurable MM based on the modified International Myeloma Working Group (IMWG) guidelines, defined by at least one of the following: Serum M-protein
- ≥ 0.5 g/dL by serum electrophoresis (SPEP), urinary M-protein excretion ≥ 200 mg/24 hours by urine electrophoresis (UPEP), and free light chain (FLC) ≥ 100 mg/L, provided that the FLC ratio is abnormal.
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- Patients with non-secretory multiple myeloma will be included if they have 25% or more of plasmacytoma size progression or appearance of new plasmacytoma lesions.
- Must have at least previously received ≥ 1 anti-MM regimens
- More than 6 months have passed since an allogeneic transplant or 100 days since an autologous stem cell transplant, if patients had any
- Adequate hepatic function within 28 days prior to C1D1:
- Total bilirubin < 1.5 × upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 × ULN), and
- Aspartate aminotransferase (AST) and alanine aminotransferase (3) normal to<2 × ULN.
- Calculated creatinine clearance (CrCl) >15 mL/min based on the Cockcroft and Gault formula.
- Adequate hematopoietic function within 7 days prior to C1D1: total white blood cell (WBC) count ≥1500/mm3, absolute neutrophil count ≥1000/mm3, hemoglobin
- ≥8.5 g/dL and platelet count ≥75,000/mm3
- Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (eg, eltrombopag, romiplostim, or interleukin-11) must have at least a 2-week interval between growth factor support and the Screening assessments, but they may receive growth factor support during the study.
- Patients must have:
- At least a 2-week interval from the last red blood cell (RBC) transfusion prior to the Screening hemoglobin assessment, and
- At least a 1-week interval from the last platelet transfusion prior to the Screening platelet assessment.
- Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly
- Effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
Who cannot join
- Patients meeting any of the following exclusion criteria are not eligible to enroll in this study:
- Has received selinexor or another XPO1 inhibitor previously.
- Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
- Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
- Pregnant or breastfeeding females.
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- Life expectancy of <6 months
- Major surgery within 6 weeks prior to C1D1.
- Patients with active hepatitis B virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 IU/mL.
- Patients with untreated hepatitis C virus (HCV) are eligible if there is a documentation of negative viral load per institutional standard.
- Patients with history of human immunodeficiency virus (HIV) are eligible if they have cluster of differentiation 4 (CD4+ )T-cell counts ≥350 cells/µL, negative viral load per institutional standard, and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year.
- Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
- Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the National Cancer Comprehensive Network (NCCN) for antiemesis and anorexia/cachexia (palliative care).
- Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
- Contraindication to any of the required concomitant drugs or supportive treatments.
- Patients unwilling or unable to comply with the protocol including providing 24-hour urine samples for urine protein electrophoresis at the required time points.
About this study
Official title: A Phase II, Single-Arm, Study of Elotuzumab, Selinexor, and Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma
The food and drug administration (FDA) has approved the use of Selinexor, an oral, first-in class, exportin 1 (XPO1) inhibitor, in combination with low-dose dexamethasone in patients with triple-refractory (disease refractory to proteasome inhibitors (PI), immunomodulatory imid agents (IMiD), and anti-Cluster of Differentiation 38 (CD38) monoclonal antibodies (mAb)), or relapsed refractory multiple myeloma (RRMM). SLAMF7 (human Signaling Lymphocyte Activation Molecule Family 7) is a receptor that is present on immune cells, NK (Natural Killer) cells, and plasma cells. Elotuzumab, a mAb directed against the extracellular domain of SLAMF7, is used in combination with an IMiD and dexamethasone to treat RRMM. In this clinical trial, the investigators are proposing the addition of Elotuzumab to Selinexor and low-dose dexamethasone (ESd) in RRMM, previously treated with one or a combination of PI's, IMiD's, and anti-CD38 mAb.
Read the detailed description
Selinexor reversibly inhibits nuclear export of tumor suppressor proteins (TSPs) resulting in a pro-apoptotic effect. In addition, previous studies found that selinexor alone or in combination with anti-PD-L1 (Programmed Death-Ligand 1) antibody significantly increased the frequency of natural killer cells on immunophenotypic analysis of splenocytes by flow cytometry. Elotuzumab activates NK cells through SLAMF7 and results in NK cell-mediated antibody dependent cellular toxicity (ADCC.) This clinical trial is designed on the premise that these two medications could have a synergistic effect resulting in a better clinical response in the treatment of RRMM.
The investigators will evaluate the ORR (overall response rate), CR (Complete Response), VGPR (Very Good Partial Response), PR (Partial Response) rates and the duration of response. Special consideration will be given to multiple myeloma patients with t(11;14) (q13;q32), given it is the most common chromosome translocation in multiple myeloma with early reported activity of Selinexor on BCR (Breakpoint Cluster Region Protein) inhibition. Finally, the investigators will evaluate the correlation between NK function and the response rate to possibly develop a predictive model of response rate to the combination based on NK activity measurements, pre, during, and post treatment. Quantitative testing includes the number of NK (CD3-, CD56/16+) cells, NK subsets (CD56bright to CD56dim ratio) and qualitative testing includes chromium release assay (using 51Cr) for cytotoxicity testing. In addition, the investigators will follow the response of African American patients to this regimen in an ancillary, ad hoc study given the under representation in the STORM (Selinexor Treatment of Refractory Myeloma) trial.
- Being tested
- Elotuzumab, Selinexor, and Dexamethasone (ESd)
- Keywords
- Multiple myeloma, Relapsed, Refractory
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elotuzumab, Selinexor, and Dexamethasone (ESd)Drug
This is a single-arm, interventional, phase II clinical trial, in which the anticipated 18 enrolled patients will receive the trial drug, a combination of Elotuzumab, Selinexor, and Dexamethasone in monthly cycles. The study tests the theory of synergy between these drugs, as detailed in the study description above.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | This study employs a single, intervention arm or group, anticipated size of which is 18 patients, in which all enrolled subjects will receive the study drug, ESd. Receives: Drug: Elotuzumab, Selinexor, and Dexamethasone (ESd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of relapsed refractory multiple myeloma (RRMM) patient to elotuzumab, selinexor, and dexamethasone (ESd).
Calculate the Overall Response Rate (ORR) as the percentage of participants responding, as per the international working myeloma group (IMWG) criteria, mainly by following bone marrow plasma cell, serum, and urine monoclonal protein and free light chain production, by the date of study completion and on further, predetermined, follow up intervals of the study participants.
Measured: 18-24 months.
Secondary outcomes (3)
Incidence of adverse events in RRMM patients treated with ESd.
Will be assessed per the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 which is a standardized scale used to quantify the severity of chemotherapy-related adverse events, ranging from grade I, which is the mildest, to grade 4, which is the most severe, and grade 5, which is death.
Measured: 18-24 months.
Duration of Response (DOR) of RRMM patients to ESd.
DOR is determined by the length of time in months from when measurement criteria for response were first met until the date of first recurrence, progressive disease [PD] or death. The unit of measure is month.
Measured: 18-24 months.
Overall Survival (OS) of RRMM patients treated with ESd.
The investigators will determine the OS to ESd in patients with MM refractory to at least one prior line of treatment. The unit of measure is month.
Measured: 18-24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start27 Apr 2022
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Why it stopped: The study collaborator -Karyopharm- is not doing Myeloma studies funding, so they let the study investigators know they are not funding the study anymore.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Relapsed Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients enrolled in this clinical trial will receive the study drugs; elotuzumab, selinexor, and dexamethasone (ESd).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Karyopharm Therapeutics Inc
- Responsible party
- Sponsor
- Investigators
- Hana Safah, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170789
- Sponsor's protocol ID
- IST-342
- Acronym
- ESdRRMM
- Status last verified
- Apr 2022
- First submitted
- 11 Oct 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reversal of immune tolerance and increased anti tumoral immune response in a mouse model of CNS B cell lymphoma after combined XPO1 and BCR inhibition Marta Crespo, Isabel Jiménez, Júlia Carabia, Sabela Bobillo, Pau Abrisqueta, Carles Palacio, Juan Camilo Nieto, Joan Boix, Cecilia del Carmen Carpio, Josep Castellví, Joan Seoane and Francesc Bosch Cancer Res July 1 2018 (78) (13 Supplement) 4568; DOI: 10.1158/1538-7445.AM2018-4568
Farren MR, Hennessey RC, Shakya R, Elnaggar O, Young G, Kendra K, Landesman Y, Elloul S, Crochiere M, Klebanov B, Kashyap T, Burd CE, Lesinski GB. The Exportin-1 Inhibitor Selinexor Exerts Superior Antitumor Activity when Combined with T-Cell Checkpoint Inhibitors. Mol Cancer Ther. 2017 Mar;16(3):417-427. doi: 10.1158/1535-7163.MCT-16-0498. Epub 2017 Feb 1.
PubMed 28148715An G, Xu Y, Shi L, Zou D, Deng S, Sui W, Xie Z, Hao M, Chang H, Qiu L. t(11;14) multiple myeloma: a subtype associated with distinct immunological features, immunophenotypic characteristics but divergent outcome. Leuk Res. 2013 Oct;37(10):1251-7. doi: 10.1016/j.leukres.2013.06.020. Epub 2013 Aug 5.
PubMed 23927993Chari A, Vogl DT, Gavriatopoulou M, Nooka AK, Yee AJ, Huff CA, Moreau P, Dingli D, Cole C, Lonial S, Dimopoulos M, Stewart AK, Richter J, Vij R, Tuchman S, Raab MS, Weisel KC, Delforge M, Cornell RF, Kaminetzky D, Hoffman JE, Costa LJ, Parker TL, Levy M, Schreder M, Meuleman N, Frenzel L, Mohty M, Choquet S, Schiller G, Comenzo RL, Engelhardt M, Illmer T, Vlummens P, Doyen C, Facon T, Karlin L, Perrot A, Podar K, Kauffman MG, Shacham S, Li L, Tang S, Picklesimer C, Saint-Martin JR, Crochiere M, Chang H, Parekh S, Landesman Y, Shah J, Richardson PG, Jagannath S. Oral Selinexor-Dexamethasone for Triple-Class Refractory Multiple Myeloma. N Engl J Med. 2019 Aug 22;381(8):727-738. doi: 10.1056/NEJMoa1903455.
PubMed 31433920
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Arm, Study of Elotuzumab, Selinexor, and Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05170789
- Acronym / sponsor ID
- ESdRRMM / IST-342
- Keywords
- Multiple myeloma, Relapsed, Refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study collaborator -Karyopharm- is not doing Myeloma studies funding, so they let the study investigators know they are not funding the study anymore.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tulane University School of MedicineUniversity, hospital or other
- Collaborators
- Karyopharm Therapeutics Inc
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The food and drug administration (FDA) has approved the use of Selinexor, an oral, first-in class, exportin 1 (XPO1) inhibitor, in combination with low-dose dexamethasone in patients with triple-refractory (disease refractory to proteasome inhibitors (PI), immunomodulatory imid agents (IMiD), and anti-Cluster of Differentiation 38 (CD38) monoclonal antibodies (mAb)), or relapsed refractory multiple myeloma (RRMM). SLAMF7 (human Signaling Lymphocyte Activation Molecule Family 7) is a receptor that is present on immune cells, NK (Natural Killer) cells, and plasma cells. Elotuzumab, a mAb directed against the extracellular domain of SLAMF7, is used in combination with an IMiD and dexamethasone to treat RRMM. In this clinical trial, the investigators are proposing the addition of Elotuzumab to Selinexor and low-dose dexamethasone (ESd) in RRMM, previously treated with one or a combination of PI's, IMiD's, and anti-CD38 mAb.
Detailed description
Selinexor reversibly inhibits nuclear export of tumor suppressor proteins (TSPs) resulting in a pro-apoptotic effect. In addition, previous studies found that selinexor alone or in combination with anti-PD-L1 (Programmed Death-Ligand 1) antibody significantly increased the frequency of natural killer cells on immunophenotypic analysis of splenocytes by flow cytometry. Elotuzumab activates NK cells through SLAMF7 and results in NK cell-mediated antibody dependent cellular toxicity (ADCC.) This clinical trial is designed on the premise that these two medications could have a synergistic effect resulting in a better clinical response in the treatment of RRMM.
The investigators will evaluate the ORR (overall response rate), CR (Complete Response), VGPR (Very Good Partial Response), PR (Partial Response) rates and the duration of response. Special consideration will be given to multiple myeloma patients with t(11;14) (q13;q32), given it is the most common chromosome translocation in multiple myeloma with early reported activity of Selinexor on BCR (Breakpoint Cluster Region Protein) inhibition. Finally, the investigators will evaluate the correlation between NK function and the response rate to possibly develop a predictive model of response rate to the combination based on NK activity measurements, pre, during, and post treatment. Quantitative testing includes the number of NK (CD3-, CD56/16+) cells, NK subsets (CD56bright to CD56dim ratio) and qualitative testing includes chromium release assay (using 51Cr) for cytotoxicity testing. In addition, the investigators will follow the response of African American patients to this regimen in an ancillary, ad hoc study given the under representation in the STORM (Selinexor Treatment of Refractory Myeloma) trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients enrolled in this clinical trial will receive the study drugs; elotuzumab, selinexor, and dexamethasone (ESd).
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: Elotuzumab, Selinexor, and Dexamethasone (ESd)This study employs a single, intervention arm or group, anticipated size of which is 18 patients, in which all enrolled subjects will receive the study drug, ESd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
- Age ≥ 18 years
- Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 2
- Having measurable MM based on the modified International Myeloma Working Group (IMWG) guidelines, defined by at least one of the following: Serum M-protein
Key exclusion criteria (16 listed)
- Patients meeting any of the following exclusion criteria are not eligible to enroll in this study:
- Has received selinexor or another XPO1 inhibitor previously.
- Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
- Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elotuzumab, Selinexor, and Dexamethasone (ESd)This is a single-arm, interventional, phase II clinical trial, in which the anticipated 18 enrolled patients will receive the trial drug, a combination of Elotuzumab, Selinexor, and Dexamethasone in monthly cycles. The study tests the theory of synergy between these drugs, as detailed in the study description above. | Drug | Intervention arm |
Primary outcome
Response of relapsed refractory multiple myeloma (RRMM) patient to elotuzumab, selinexor, and dexamethasone (ESd).
Time frame: 18-24 months.
Calculate the Overall Response Rate (ORR) as the percentage of participants responding, as per the international working myeloma group (IMWG) criteria, mainly by following bone marrow plasma cell, serum, and urine monoclonal protein and free light chain production, by the date of study completion and on further, predetermined, follow up intervals of the study participants.
3 secondary outcomes
Incidence of adverse events in RRMM patients treated with ESd.
Time frame: 18-24 months.
Duration of Response (DOR) of RRMM patients to ESd.
Time frame: 18-24 months.
Overall Survival (OS) of RRMM patients treated with ESd.
Time frame: 18-24 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- BackgroundReversal of immune tolerance and increased anti tumoral immune response in a mouse model of CNS B cell lymphoma after combined XPO1 and BCR inhibition Marta Crespo, Isabel Jiménez, Júlia Carabia, Sabela Bobillo, Pau Abrisqueta, Carles Palacio, Juan Camilo Nieto, Joan Boix, Cecilia del Carmen Carpio, Josep Castellví, Joan Seoane and Francesc Bosch Cancer Res July 1 2018 (78) (13 Supplement) 4568; DOI: 10.1158/1538-7445.AM2018-4568
- Results publication: PubMed 28148715Farren MR, Hennessey RC, Shakya R, Elnaggar O, Young G, Kendra K, Landesman Y, Elloul S, Crochiere M, Klebanov B, Kashyap T, Burd CE, Lesinski GB. The Exportin-1 Inhibitor Selinexor Exerts Superior Antitumor Activity when Combined with T-Cell Checkpoint Inhibitors. Mol Cancer Ther. 2017 Mar;16(3):417-427. doi: 10.1158/1535-7163.MCT-16-0498. Epub 2017 Feb 1.
- Results publication: PubMed 23927993An G, Xu Y, Shi L, Zou D, Deng S, Sui W, Xie Z, Hao M, Chang H, Qiu L. t(11;14) multiple myeloma: a subtype associated with distinct immunological features, immunophenotypic characteristics but divergent outcome. Leuk Res. 2013 Oct;37(10):1251-7. doi: 10.1016/j.leukres.2013.06.020. Epub 2013 Aug 5.
- Results publication: PubMed 31433920Chari A, Vogl DT, Gavriatopoulou M, Nooka AK, Yee AJ, Huff CA, Moreau P, Dingli D, Cole C, Lonial S, Dimopoulos M, Stewart AK, Richter J, Vij R, Tuchman S, Raab MS, Weisel KC, Delforge M, Cornell RF, Kaminetzky D, Hoffman JE, Costa LJ, Parker TL, Levy M, Schreder M, Meuleman N, Frenzel L, Mohty M, Choquet S, Schiller G, Comenzo RL, Engelhardt M, Illmer T, Vlummens P, Doyen C, Facon T, Karlin L, Perrot A, Podar K, Kauffman MG, Shacham S, Li L, Tang S, Picklesimer C, Saint-Martin JR, Crochiere M, Chang H, Parekh S, Landesman Y, Shah J, Richardson PG, Jagannath S. Oral Selinexor-Dexamethasone for Triple-Class Refractory Multiple Myeloma. N Engl J Med. 2019 Aug 22;381(8):727-738. doi: 10.1056/NEJMoa1903455.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hana Safah, MD principal investigator
Tulane University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elotuzumab, Selinexor, and Dexamethasone (ESd) in people with Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by Tulane University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of relapsed refractory multiple myeloma (RRMM) patient to elotuzumab, selinexor, and dexamethasone (ESd). (time frame: 18-24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05170789, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.