RECRUITING

Selinexor and Backbone Treatments of Multiple Myeloma Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will independently assess the efficacy and safety of 11 combination therapies in 12 arms, in dose-escalation/-evaluation and expansion phases, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be evaluated are: * Arm 1: Selinexor + dexamethasone + pomalidomide (SPd); enrollment complete * Arm 2: Selinexor + dexamethasone + bortezomib (SVd); enrollment complete * Arm 3: Selinexor + dexamethasone + lenalidomide (SRd) in RRMM; enrollment complete * Arm 4: Selinexor + dexamethasone + pomalidomide + bortezomib (SPVd); enrollment complete * Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete * Arm 6: Selinexor + dexamethasone + carfilzomib (SKd); enrollment complete * Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM; enrollment complete * Arm 8: Selinexor + dexamethasone + ixazomib (SNd); enrollment complete * Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd); enrollment complete * Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd); enrollment complete * Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd); enrollment complete * Arm 12: Selinexor + dexamethasone + mezigdomide (SMd); actively recruiting Selinexor pharmacokinetics: * PK Run-in (Days 1-14): Starting in protocol version 8.0, patients enrolled to any arm in the Dose Escalation Phase (i.e., Arm 4 \[SPVd\], Arm 6 \[SKd\], Arm 8 \[SNd\], Arm 9 \[SPEd\], Arm 10 \[SBd\], and Arm 11 \[SDPd\]) will also first be enrolled to a pharmacokinetics (PK) Run-in period until 9 patients have been enrolled to this period to evaluate the PK of selinexor before and after co-administration with a strong CYP3A4 inhibitor. This run-in period does not apply to Arm 12 (SMd).

Official Title

A Phase 1b/2 Study of Selinexor (KPT-330) in Combination with Backbone Treatments for Relapsed/Refractory Multiple Myeloma and Newly Diagnosed Multiple Myeloma

Quick Facts

Study Start:2015-10

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02343042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Written informed consent signed in accordance with federal, local, and institutional guidelines. 2. Age greater than or equal to (≥) 18 years at the time of informed consent. 3. Histologically confirmed diagnosis with measurable disease for relapsed/refractory myeloma. 4. Symptomatic MM, based on IMWG guidelines. 5. Patients must have measurable disease as defined by at least one of the following: 1. Serum M-protein ≥ 0.5 gram per deciliter (g/dL) by serum protein electrophoresis (SPEP) or, for immunoglobulin A (IgA) myeloma, by quantitative IgA 2. Urinary M-protein excretion at least 200 mg/24 hours 3. Serum free light chain (FLC) ≥ 100 milligram per liter (mg/L), provided that FLC ratio is abnormal 4. If SPEP is felt to be unreliable for routine M-protein measurement (example, for IgA MM), then quantitative immunoglobulin (Ig) levels by nephelometry or turbidometry are acceptable 6. Any non-hematological toxicities (except for peripheral neuropathy as described in exclusion criterion #22) that patients had from treatments in previous clinical studies must have resolved to less than or equal (≤) Grade 2 by C1D1. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2. 8. Adequate hepatic function within 28 days prior to C1D1: * For SPd, SRd, and SPEd: Total bilirubin \< 2\* upper limit of normal (ULN) (except patients with Gilbert's syndrome \[hereditary indirect hyperbilirubinemia\] who must have a total bilirubin of ≤ 3\* ULN) and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5\* ULN * For SVd, SPVd, SDd, SNd, SBd and SDPd: Total bilirubin of \< 1.5\* ULN (except patients with Gilbert's syndrome \[hereditary indirect hyperbilirubinemia\] who must have a total bilirubin of ≤ 3\* ULN) and both AST and ALT \< 2.0\* ULN * For SKd and SMd: Total bilirubin \< 2x ULN (except patients with Gilbert's syndrome \[hereditary indirect hyperbilirubinemia\] who must have a total bilirubin of ≤ 3x ULN) and both AST and ALT \< 3.0x ULN 9. Adequate renal function within 28 days prior to C1D1. For Arms 1-11, estimated creatinine clearance (CrCl) calculated using the formula of Cockroft and Gault (1976). * ≥ 20 milliliter per minute (mL/min) for SVd, SDd, and SKd arms * ≥ 30 mL/min for SNd, SBd, and SMd arms * ≥ 45 mL/min for SPd, SPVd, SPEd and SDPd arms * \> 60 mL/min for SRd arm 10. Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count (ANC) ≥ 1,000/mm\^3, hemoglobin (Hb) ≥ 8.0 g/dL, and platelet count ≥ 100,000/mm\^3. * SPVd (Arm 4) and SKd (Arm 6) only: platelet count ≥150,000. * SMd (Arm 12) only: platelet count ≥75,000 for subjects in whom \<50% of bone marrow nucleated cells are plasma cells; or platelet count \<50,000 for subjects in whom ≥50% of bone marrow nucleated cells are plasma cells. 11. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients must use highly effective methods of contraception throughout the study and for 90 days following the last dose of study treatment. For Arm 12 (SMd), all study subjects must agree and adhere to all testing and contraception requirements as specified in the mezigdomide Global Pregnancy Prevention Plan (PPP) 12. Relapsed or refractory MM with: 1. Documented evidence of progressive disease (PD) after achieving at least stable disease (SD) for ≥ 1 cycle during a previous MM regimen (i.e., relapsed MM) 2. ≤ 25 percent (%) response (i.e., patients never achieved ≥ MR) or PD during or within 60 days from the end of the most recent MM regimen (i.e., refractory MM) 3. Previously undergone ≥ 2 cycles of lenalidomide and a PI (in separate therapeutic regimens \[not for maintenance\] or in combination) 4. In the expansion arm at RP2D, patients must not be pomalidomide refractory 13. Relapsed or refractory MM with: 1. Documented evidence of relapse after ≥ 1 previous line of therapy 2. Not refractory to bortezomib in their most recent line of therapy 14. Patients who received ≥ 1 prior therapeutic regimen (prior lenalidomide is allowed as long as patient's MM was not refractory to prior lenalidomide; patients whose MM was refractory to lenalidomide maintenance regimens will be allowed in this cohort). 15. Patients who received 1- 3 prior lines of therapy, including ≥ 2 cycles of lenalidomide and have demonstrated disease progression on their last therapy (may include prior bortezomib, as long as the patient's MM was not refractory to bortezomib therapy), but patients must be pomalidomide-naïve in the Dose Expansion at RP2D (Cohort 4.3 ONLY). 16. Patients who received ≥ 3 prior lines of therapy, including a PI and an immunomodulatory agent (IMiD), or patients with MM refractory to both a PI and an IMiD. 17. Patients must not have received prior anti-cluster of differentiation 38 (anti-CD38) monoclonal antibodies (Cohort 5.3 ONLY - Dose Expansion at RP2D). 18. Patients may have received prior PIs; however, their MM must NOT be refractory to carfilzomib. 19. Patients must have symptomatic myeloma per IMWG guidelines with either CRAB criteria (calcium elevation, renal failure, anemia, lytic bone lesions) or myeloma-defining events and need systemic therapy. No prior systemic therapy for NDMM is permitted other than pulse dose dexamethasone (maximum dose of 160 mg) or corticosteroid equivalent. 20. Patients must have MM that relapsed after 1 - 3 prior lines of therapy (may not include those with MM refractory to bortezomib or carfilzomib but patients must be ixazomib-naïve). 21. Patients who received ≥ 2 prior therapies, including lenalidomide and a proteasome inhibitor (in separate or the same regimens), but patients must be pomalidomide-naive and elotuzumab-naive in the Dose Expansion at RP2D (Cohort 9.3 ONLY). 22. Patients who have MM that was refractory to an IMiD, a proteasome inhibitor, and refractory or intolerant (or both) to an anti-CD38 monoclonal antibody. Patients must be belantamab mafodotin-naive in the Dose Expansion cohort at RP2D (Cohort 10.3 ONLY). 23. Patients who received 1-3 prior therapies, including lenalidomide and a proteasome inhibitor (in separate or the same regimen), but patients must be pomalidomide-naive and daratumumab-naive in the Dose Expansion cohort at RP2D (Cohort 11.3 ONLY). 24. Patients with RRMM who have received at least 2 prior lines of therapy, including an IMiD, a PI, and an anti-CD38 monoclonal antibody. Patients must have either failed a T-cell redirecting treatment (eg, CAR-T or bispecific antibody) or otherwise cannot receive such therapy due to either medical or logistic reasons.	1. Smoldering MM. 2. MM that does not express M-protein or FLC (i.e., non-secretory MM is excluded), and quantitative immunoglobulin levels cannot be used instead. 3. Documented active systemic amyloid light chain amyloidosis. 4. Active plasma cell leukemia. 5. Red Blood Cell (RBC) and platelet transfusions and blood growth factors within 14 days of C1D1 (Arms 1-11 only). Red blood cells and platelet transfusions and blood growth factors within 7 days of C1D1 (Arm 12). 6. Platelet transfusion or G-CSF within 7 days or pegfilgastrim within 14 days prior to the complete blood count (CBC) used to determine eligibility. 7. Radiation, chemotherapy, or immunotherapy or any other tumor-directed therapy ≤ 2 weeks prior to C1D1, and radio-immunotherapy within 6 weeks prior to C1D1. Patients on long-term glucocorticoids during Screening do not require a washout period. Spot radiation is permitted at any time for treatment of fractures or to prevent fractures as well as for pain management. 8. Patients with history of spinal cord compression with residual paraplegia (Dose Escalation Phase only). 9. Treatment with an investigational anti-cancer therapy within 3 weeks prior to C1D1. 10. Prior autologous stem cell transplantation \< 1 month, or allogeneic stem cell transplantation \< 3 months prior to C1D1. 11. Active graft versus host disease after allogeneic stem cell transplantation. 12. Life expectancy \< 3 months. 13. Major surgery within 4 weeks prior to C1D1. 14. Active, unstable cardiovascular function: 1. Symptomatic ischemia, or 2. Uncontrolled clinically-significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics are excluded; patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded), or 3. Congestive heart failure (CHF) of New York Heart Association (NYHA) Class ≥ 3, or 4. Myocardial infarction (MI) within 3 months prior to C1D1 5. Ejection fraction (EF) \< 50% at Screening (Arms 1-11 only, screening echocardiogram not required for Arm 12, SMd) 15. Uncontrolled active hypertension (Arms 1-11 only). 16. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose. 17. Known active hepatitis A, B or C. 18. Known human immunodeficiency virus (HIV) infection or HIV seropositivity. 19. Any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment. 20. Currently pregnant or breastfeeding. 21. A serious active psychiatric or active medical condition which, in the opinion of the Investigator, could interfere with treatment. 22. Hypersensitivity to any of the treatments for the arm in which the patient is enrolled. 23. SVd Arm (Arm 2), SPVd (Arm 4), and SNd Arm (Arm 8) only: Prior history of neuropathy Grade \> 2, or Grade ≥ 2 neuropathy with pain at Screening (within 28 days prior to C1D1). 24. Patients who are eligible for the selinexor PK Run-in only: Treatment with moderate or strong inhibitors/inducers of CYP3A within 7 days prior to Day 1 of the PK Run-in period. 25. Patients who are eligible for the selinexor PK Run-in only: Not able to receive a strong CYP3A4 inhibitor due to concomitant medications. 26. SKd arm only: HBs Ag + plus HBc Ab + even though no active hepatitis B virus (HBV) hepatitis. If HBs Ag - plus HBc Ab +, treating physician needs to contact the medical monitor. 27. Prior exposure to a selective inhibitor of nuclear export (SINE) compound, including selinexor. 28. Current corneal epithelial disease except mild punctate keratopathy. 29. History of allogeneic stem cell or solid organ transplant at any time. 30. History of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide (including ≥Grade 3 rash during prior thalidomide, lenalidomide, or pomalidomide therapy), carfilzomib or dexamethasone, any CELMoD agents, or the excipients contained in the formulations, or subject has any contraindications per local prescribing information. 31. Subject is unable or unwilling to agree to refrain from donating blood while on study intervention, during dose interruptions, and for at least 28 days following the last dose of study intervention. 32. Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis. 33. Use of strong CYP3A4 modulator or proton-pump inhibitors (eg, omeprazole, lansoprazole), within 2 weeks of starting study intervention. 34. Active concomitant malignancies or history of another malignancy within 3 years prior to C1D1 except for adequately treated early-stage basal cell or squamous cell carcinoma of skin, adequately treated carcinoma in situ of breast or cervix, or organ confined prostate cancer. 35. History of chronic hepatitis B with detectable viral load. 36. Subject is unable or unwilling to receive protocol-required dual antiemetic prophylaxis

Inclusion Criteria

Exclusion Criteria

1. Written informed consent signed in accordance with federal, local, and institutional guidelines.
2. Age greater than or equal to (≥) 18 years at the time of informed consent.
3. Histologically confirmed diagnosis with measurable disease for relapsed/refractory myeloma.
4. Symptomatic MM, based on IMWG guidelines.
5. Patients must have measurable disease as defined by at least one of the following:
1. Serum M-protein ≥ 0.5 gram per deciliter (g/dL) by serum protein electrophoresis (SPEP) or, for immunoglobulin A (IgA) myeloma, by quantitative IgA
2. Urinary M-protein excretion at least 200 mg/24 hours
3. Serum free light chain (FLC) ≥ 100 milligram per liter (mg/L), provided that FLC ratio is abnormal
4. If SPEP is felt to be unreliable for routine M-protein measurement (example, for IgA MM), then quantitative immunoglobulin (Ig) levels by nephelometry or turbidometry are acceptable
6. Any non-hematological toxicities (except for peripheral neuropathy as described in exclusion criterion #22) that patients had from treatments in previous clinical studies must have resolved to less than or equal (≤) Grade 2 by C1D1.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
8. Adequate hepatic function within 28 days prior to C1D1:
* For SPd, SRd, and SPEd: Total bilirubin \< 2\* upper limit of normal (ULN) (except patients with Gilbert's syndrome \[hereditary indirect hyperbilirubinemia\] who must have a total bilirubin of ≤ 3\* ULN) and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5\* ULN
* For SVd, SPVd, SDd, SNd, SBd and SDPd: Total bilirubin of \< 1.5\* ULN (except patients with Gilbert's syndrome \[hereditary indirect hyperbilirubinemia\] who must have a total bilirubin of ≤ 3\* ULN) and both AST and ALT \< 2.0\* ULN
* For SKd and SMd: Total bilirubin \< 2x ULN (except patients with Gilbert's syndrome \[hereditary indirect hyperbilirubinemia\] who must have a total bilirubin of ≤ 3x ULN) and both AST and ALT \< 3.0x ULN
9. Adequate renal function within 28 days prior to C1D1. For Arms 1-11, estimated creatinine clearance (CrCl) calculated using the formula of Cockroft and Gault (1976).
* ≥ 20 milliliter per minute (mL/min) for SVd, SDd, and SKd arms
* ≥ 30 mL/min for SNd, SBd, and SMd arms
* ≥ 45 mL/min for SPd, SPVd, SPEd and SDPd arms
* \> 60 mL/min for SRd arm
10. Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count (ANC) ≥ 1,000/mm\^3, hemoglobin (Hb) ≥ 8.0 g/dL, and platelet count ≥ 100,000/mm\^3.
* SPVd (Arm 4) and SKd (Arm 6) only: platelet count ≥150,000.
* SMd (Arm 12) only: platelet count ≥75,000 for subjects in whom \<50% of bone marrow nucleated cells are plasma cells; or platelet count \<50,000 for subjects in whom ≥50% of bone marrow nucleated cells are plasma cells.
11. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients must use highly effective methods of contraception throughout the study and for 90 days following the last dose of study treatment. For Arm 12 (SMd), all study subjects must agree and adhere to all testing and contraception requirements as specified in the mezigdomide Global Pregnancy Prevention Plan (PPP)
12. Relapsed or refractory MM with:
1. Documented evidence of progressive disease (PD) after achieving at least stable disease (SD) for ≥ 1 cycle during a previous MM regimen (i.e., relapsed MM)
2. ≤ 25 percent (%) response (i.e., patients never achieved ≥ MR) or PD during or within 60 days from the end of the most recent MM regimen (i.e., refractory MM)
3. Previously undergone ≥ 2 cycles of lenalidomide and a PI (in separate therapeutic regimens \[not for maintenance\] or in combination)
4. In the expansion arm at RP2D, patients must not be pomalidomide refractory
13. Relapsed or refractory MM with:
1. Documented evidence of relapse after ≥ 1 previous line of therapy
2. Not refractory to bortezomib in their most recent line of therapy
14. Patients who received ≥ 1 prior therapeutic regimen (prior lenalidomide is allowed as long as patient's MM was not refractory to prior lenalidomide; patients whose MM was refractory to lenalidomide maintenance regimens will be allowed in this cohort).
15. Patients who received 1- 3 prior lines of therapy, including ≥ 2 cycles of lenalidomide and have demonstrated disease progression on their last therapy (may include prior bortezomib, as long as the patient's MM was not refractory to bortezomib therapy), but patients must be pomalidomide-naïve in the Dose Expansion at RP2D (Cohort 4.3 ONLY).
16. Patients who received ≥ 3 prior lines of therapy, including a PI and an immunomodulatory agent (IMiD), or patients with MM refractory to both a PI and an IMiD.
17. Patients must not have received prior anti-cluster of differentiation 38 (anti-CD38) monoclonal antibodies (Cohort 5.3 ONLY - Dose Expansion at RP2D).
18. Patients may have received prior PIs; however, their MM must NOT be refractory to carfilzomib.
19. Patients must have symptomatic myeloma per IMWG guidelines with either CRAB criteria (calcium elevation, renal failure, anemia, lytic bone lesions) or myeloma-defining events and need systemic therapy. No prior systemic therapy for NDMM is permitted other than pulse dose dexamethasone (maximum dose of 160 mg) or corticosteroid equivalent.
20. Patients must have MM that relapsed after 1 - 3 prior lines of therapy (may not include those with MM refractory to bortezomib or carfilzomib but patients must be ixazomib-naïve).
21. Patients who received ≥ 2 prior therapies, including lenalidomide and a proteasome inhibitor (in separate or the same regimens), but patients must be pomalidomide-naive and elotuzumab-naive in the Dose Expansion at RP2D (Cohort 9.3 ONLY).
22. Patients who have MM that was refractory to an IMiD, a proteasome inhibitor, and refractory or intolerant (or both) to an anti-CD38 monoclonal antibody. Patients must be belantamab mafodotin-naive in the Dose Expansion cohort at RP2D (Cohort 10.3 ONLY).
23. Patients who received 1-3 prior therapies, including lenalidomide and a proteasome inhibitor (in separate or the same regimen), but patients must be pomalidomide-naive and daratumumab-naive in the Dose Expansion cohort at RP2D (Cohort 11.3 ONLY).
24. Patients with RRMM who have received at least 2 prior lines of therapy, including an IMiD, a PI, and an anti-CD38 monoclonal antibody. Patients must have either failed a T-cell redirecting treatment (eg, CAR-T or bispecific antibody) or otherwise cannot receive such therapy due to either medical or logistic reasons.

1. Smoldering MM.
2. MM that does not express M-protein or FLC (i.e., non-secretory MM is excluded), and quantitative immunoglobulin levels cannot be used instead.
3. Documented active systemic amyloid light chain amyloidosis.
4. Active plasma cell leukemia.
5. Red Blood Cell (RBC) and platelet transfusions and blood growth factors within 14 days of C1D1 (Arms 1-11 only). Red blood cells and platelet transfusions and blood growth factors within 7 days of C1D1 (Arm 12).
6. Platelet transfusion or G-CSF within 7 days or pegfilgastrim within 14 days prior to the complete blood count (CBC) used to determine eligibility.
7. Radiation, chemotherapy, or immunotherapy or any other tumor-directed therapy ≤ 2 weeks prior to C1D1, and radio-immunotherapy within 6 weeks prior to C1D1. Patients on long-term glucocorticoids during Screening do not require a washout period. Spot radiation is permitted at any time for treatment of fractures or to prevent fractures as well as for pain management.
8. Patients with history of spinal cord compression with residual paraplegia (Dose Escalation Phase only).
9. Treatment with an investigational anti-cancer therapy within 3 weeks prior to C1D1.
10. Prior autologous stem cell transplantation \< 1 month, or allogeneic stem cell transplantation \< 3 months prior to C1D1.
11. Active graft versus host disease after allogeneic stem cell transplantation.
12. Life expectancy \< 3 months.
13. Major surgery within 4 weeks prior to C1D1.
14. Active, unstable cardiovascular function:
1. Symptomatic ischemia, or
2. Uncontrolled clinically-significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics are excluded; patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded), or
3. Congestive heart failure (CHF) of New York Heart Association (NYHA) Class ≥ 3, or
4. Myocardial infarction (MI) within 3 months prior to C1D1
5. Ejection fraction (EF) \< 50% at Screening (Arms 1-11 only, screening echocardiogram not required for Arm 12, SMd)
15. Uncontrolled active hypertension (Arms 1-11 only).
16. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose.
17. Known active hepatitis A, B or C.
18. Known human immunodeficiency virus (HIV) infection or HIV seropositivity.
19. Any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment.
20. Currently pregnant or breastfeeding.
21. A serious active psychiatric or active medical condition which, in the opinion of the Investigator, could interfere with treatment.
22. Hypersensitivity to any of the treatments for the arm in which the patient is enrolled.
23. SVd Arm (Arm 2), SPVd (Arm 4), and SNd Arm (Arm 8) only: Prior history of neuropathy Grade \> 2, or Grade ≥ 2 neuropathy with pain at Screening (within 28 days prior to C1D1).
24. Patients who are eligible for the selinexor PK Run-in only: Treatment with moderate or strong inhibitors/inducers of CYP3A within 7 days prior to Day 1 of the PK Run-in period.
25. Patients who are eligible for the selinexor PK Run-in only: Not able to receive a strong CYP3A4 inhibitor due to concomitant medications.
26. SKd arm only: HBs Ag + plus HBc Ab + even though no active hepatitis B virus (HBV) hepatitis. If HBs Ag - plus HBc Ab +, treating physician needs to contact the medical monitor.
27. Prior exposure to a selective inhibitor of nuclear export (SINE) compound, including selinexor.
28. Current corneal epithelial disease except mild punctate keratopathy.
29. History of allogeneic stem cell or solid organ transplant at any time.
30. History of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide (including ≥Grade 3 rash during prior thalidomide, lenalidomide, or pomalidomide therapy), carfilzomib or dexamethasone, any CELMoD agents, or the excipients contained in the formulations, or subject has any contraindications per local prescribing information.
31. Subject is unable or unwilling to agree to refrain from donating blood while on study intervention, during dose interruptions, and for at least 28 days following the last dose of study intervention.
32. Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis.
33. Use of strong CYP3A4 modulator or proton-pump inhibitors (eg, omeprazole, lansoprazole), within 2 weeks of starting study intervention.
34. Active concomitant malignancies or history of another malignancy within 3 years prior to C1D1 except for adequately treated early-stage basal cell or squamous cell carcinoma of skin, adequately treated carcinoma in situ of breast or cervix, or organ confined prostate cancer.
35. History of chronic hepatitis B with detectable viral load.
36. Subject is unable or unwilling to receive protocol-required dual antiemetic prophylaxis

Contacts and Locations

Study Contact

Karyopharm Medical Information

CONTACT

(888) 209-9326

clinicaltrials@karyopharm.com

Study Locations (Sites)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234

United States

Jonnsson Comprehensive Cancer Center / University of Los Angeles

Los Angeles, California, 0095

United States

Sarah Cannon-Colorado Blood Cancer Institute

Denver, Colorado, 80218

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, 07601

United States

Columbia University

New York, New York, 10032

United States

Weill Cornell Medicine

New York, New York, 10065

United States

Wilmot Cancer Center/ University of Rochester

Rochester, New York

United States

University of North Carolina - Chapel Hill Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Duke Institute of Cancer/ Duke University

Durham, North Carolina, 27710

United States

Sarah Cannon- Tennessee Oncology Nashville

Nashville, Tennessee, 37203

United States

Swedish Cancer Institute

Seattle, Washington, 98109

United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: Karyopharm Therapeutics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-10

Study Completion Date2027-04

Study Record Updates

Study Start Date2015-10

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

Selinexor
KCP-330
STOMP
Multiple Myeloma
Relapsed/Refractory
Dexamethasone
Pomalidomide
Bortezomib
Karyopharm
Lenalidomide
Daratumumab
Newly Diagnosed
Carfilzomib
Ixazomib
Elotuzumab
Clarithromycin
Belantamab mafodotin
Mezigdomide
CC-92480
BMS-986348

Additional Relevant MeSH Terms

Multiple Myeloma

Selinexor and Backbone Treatments of Multiple Myeloma Patients

Conditions

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Study Overview

Description

Official Title

Quick Facts

Study ID

Participation Criteria

Contacts and Locations

Study Contact

Study Locations (Sites)

Collaborators and Investigators

Study Record Dates

Study Registration Dates

Study Record Updates

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms