Selinexor and Backbone Treatments of Multiple Myeloma Patients

NCT02343042 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: KCP-330-017
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 24

Brief Summary

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).

Conditions

Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Phase 1 (Dose-escalation): Maximum Tolerated Dose (MTD)

  MTD for once weekly and twice weekly selinexor dose cohorts in the 11 Arms will be evaluated.

  12 months

• Phase 1 (Dose-escalation): Recommended Phase-2 dose (RP2D)

  RP2D for each Arm will be determined.

  12 months

• Phase 1 (Dose-escalation): Maximum Plasma Concentration (Cmax) of Selinexor

  Cmax of selinexor over a dosing interval when given with and without clarithromycin.

  Pre-dose, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin)

• Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor

  Total exposure of selinexor in the blood (AUC0-last) from the time of dosing to the last measurable concentration collected when given with and without clarithromycin.

  Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin)

• Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf)

  Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin)

• Phase 2 (Expansion): Overall response rate (ORR)

  ORR for each Arm independently. ORR to include stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to the International Myeloma Working Group (IMWG) criteria.

  12 months

• Phase 2 (Expansion): Duration of response (DOR)

  Duration of response for each Arm. DOR is defined as the number of days from the date of the first evidence of objective response until progression.

  12 months

• Phase 2 (Expansion): Clinical Benefit Rate (CBR)

  CBR is defined the point estimate of the percentage of patients in that arm who have a response of sCR, CR, VGPR, PR or Minimal response (MR), as assessed by IMWG criteria.

  12 months

Study Arms (12)

1: Selinexor, Low-dose Dexamethasone and Pomalidomide (SPd)

EXPERIMENTAL

Each cycle is of 28 days Cohort 1.1: Selinexor (SEL) 60/80/100 mg orally (PO) once weekly (QW); Dexamethasone (DEX) 40 mg PO once weekly; Pomalidomide (POM) 2/3/4 mg PO Days 1-21. Cohort 1.2: SEL 40/60/80 mg PO twice weekly (BIW); DEX 20 mg PO twice weekly; POM 3/4 mg PO Days 1-21. Cohort 1.3: Selinexor, Dexamethasone and Pomalidomide will be dosed at RP2D-1. Cohort 1.4: SEL 40 mg PO QW; DEX 40 mg PO QW; POM 4mg PO once daily (QD) Days 1-21.

Drug: Selinexor; Drug: Dexamethasone; Drug: Pomalidomide

2: Selinexor, Low-dose Dexamethasone and Bortezomib (SVd)

EXPERIMENTAL

Each cycle is of 35 days Cohort 2.1: SEL 60/80/100 mg PO once weekly; DEX 40 mg PO once weekly; Bortezomib (BOR) 1.3 milligram per meter square (mg/m\^2) subcutaneous (SC) once weekly. Cohort 2.2: SEL 40/60/80 mg PO twice weekly; DEX 20 mg PO twice weekly; BOR 1.3 mg/m\^2 subcutaneous (SC) once weekly. Cohort 2.3: Selinexor, Dexamethasone and Bortezomib will be dosed at RP2D-2.

Drug: Selinexor; Drug: Dexamethasone; Drug: Bortezomib

3: Selinexor, Low-dose DEX, and Lenalidomide (SRd) in RRMM

EXPERIMENTAL

Each cycle is of 28 days Cohort 3.1: SEL 40/60/80/100 mg PO once weekly; DEX 40 mg PO once weekly; Lenalidomide (LEN) 15/25 mg PO Days 1-21. Cohort 3.2: SEL 40/60/80 mg PO twice weekly; DEX 20 mg PO twice weekly; LEN 15/25 mg PO Days 1-21. Cohort 3.3: Selinexor, Dexamethasone and Lenalidomide will be dosed at RP2D-3.

Drug: Selinexor; Drug: Dexamethasone; Drug: Lenalidomide

4:Selinexor, Low-dose dexamethasone, Pomalidomide, Velcade (SPVd)

EXPERIMENTAL

PK Run-in Period: Selinexor and Clarithromycin: * For the first 9 patients enrolled into this dose escalation arm * 14 day run-in period after which patients will proceed to Dose-Escalation Phase C1D1 Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8. PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose. Dose-escalation Phase: * All patients enrolled into this Arm * Each cycle is of 28 days. Cohort 4.1: SEL 40/60 mg PO once weekly; DEX 40 mg PO once weekly; POM 4 mg PO Days 1-21; BOR 1.3 mg/m\^2 subcutaneous (SC) once weekly. Cohort 4.3: Selinexor, Dexamethasone, Pomalidomide, Velcade (Bortezomib) will be dosed at RP2D-4.

Drug: Selinexor; Drug: Dexamethasone; Drug: Pomalidomide; Drug: Bortezomib; Drug: Clarithromycin

5: Selinexor, Low-dose dexamethasone, and Daratumumab (SDd)

EXPERIMENTAL

Each cycle is of 28 days Cohort 5.1: SEL 80/100 mg PO once weekly; DEX 40 mg once weekly (IV or PO); DARA: 16 mg/kg IV infusion Cycle 1-2: Once weekly, Cycle 3-6: Every other week, Cycle 6 and greater: Once a month. Cohort 5.2: SEL: 60 mg PO twice weekly; DEX: 40 mg weekly (IV or PO); DARA: 16 milligram per kilogram (mg/kg) IV infusion Cycle 1-2: Once. weekly, Cycle 3-6: Every other week, Cycle 6 and greater: Once a month. Cohort 5.3: Selinexor, Dexamethasone and Daratumumab will be dosed at RP2D-5.

Drug: Selinexor; Drug: Dexamethasone; Drug: Daratumumab

6: Selinexor, Low-dose dexamethasone, and Carfilzomib (SKd)

EXPERIMENTAL

PK Run-in Period: Selinexor and Clarithromycin: * For the first 9 patients enrolled into this dose escalation arm * 14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1 Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8. PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose. Dose-Escalation Phase: * All patients enrolled into this Arm * Each cycle is of 28 days Cohort 6.1: SEL 40/60/80/100 mg PO once weekly on days 1, 8, 15, and 22; DEX 40 mg IV or PO once weekly; Carfilzomib (CAR) 56 or 70 mg/m\^2 IV infusion once weekly on days 1, 8, and 15. Cohort 6.2: SEL 60/80/100 mg PO once weekly on days 1, 8, and 15; DEX 40 mg IV or PO once weekly; CAR 56 or 70 mg/m\^2 IV infusion once weekly on days 1, 8, and 15. Cohort 6.3: Selinexor, Dexamethasone and Carfilzomib will be dosed at RP2D-6.

Drug: Selinexor; Drug: Dexamethasone; Drug: Carfilzomib; Drug: Clarithromycin

7: Selinexor, Low-dose DEX and Lenalidomide (SRd) in NDMM

EXPERIMENTAL

Each cycle is of 28 days Cohort 7.1: SEL 40/60/80 mg PO once weekly; DEX 40 mg PO once weekly; LEN 25 mg PO Days 1-21. Cohort 7.3: Selinexor, Dexamethasone and Lenalidomide will be dosed at RP2D-7.

Drug: Selinexor; Drug: Dexamethasone; Drug: Lenalidomide

8: Selinexor, Low-dose dexamethasone, and Ixazomib (SNd)

EXPERIMENTAL

PK Run-in Period: Selinexor \& Clarithromycin: * For the first 9 patients enrolled into this dose escalation arm * 14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1 Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8. PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose. Dose-Escalation Phase: * All patients enrolled into this Arm * Each cycle is of 28 days Cohort 8.1: SEL 40/60/80/100 mg PO once weekly; DEX 20 mg PO twice weekly; IXA 3/4 mg PO once weekly. Cohort 8.3: Selinexor, Dexamethasone and Ixazomib will be dosed at RP2D-8.

Drug: Selinexor; Drug: Dexamethasone; Drug: Ixazomib; Drug: Clarithromycin

9: Selinexor, Low-dose DEX, Pomalidomide and Elotuzumab (SPEd)

EXPERIMENTAL

PK Run-in Period: Selinexor and Clarithromycin: * For the first 9 patients enrolled into this dose escalation arm * 14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1 Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8. PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose. Dose-Escalation Phase: * All patients enrolled into this Arm * Each cycle is of 28 days Cohort 9.1: SEL 20/40/60 mg PO once weekly; DEX 28/20 mg PO twice weekly; POM 4 mg PO QD Days 1-21; Elotuzumab (ELO) 10/20 mg/kg IV will be given once weekly on Days 1,8, 15 and 22 of Cycles 1-2. Starting on Cycle 3 and continuing for future cycles, elotuzumab will be dosed at 20 mg/kg on Day 1 of each cycle only. Cohort 9.3: Selinexor, Dexamethasone, Pomalidomide and Elotuzumab will be dosed at RP2D-9.

Drug: Selinexor; Drug: Dexamethasone; Drug: Pomalidomide; Drug: Elotuzumab

10. Selinexor, Dexamethasone, and Belantamab Mafodotin (SBd)

EXPERIMENTAL

Each cycle is of 21 days Cohort 10.1: SEL 40/60/80 mg PO once weekly on Days 1, 8, and 15; DEX 40 mg PO QW on Days 1, 8, and 15; Belantamab Mafodotin (BEL) 2.5 mg/kg IV infusion every 3 weeks (Q3W) Day 1 of each cycle. Cohort 10.3: Selinexor, Dexamethasone, and Belantamab Mafodotin will be dosed at RP2D-10.

Drug: Selinexor; Drug: Dexamethasone; Drug: Belantamab Mafodotin

11. Selinexor, Dexamethasone, Pomalidomide, and Daratumumab (SDPd)

EXPERIMENTAL

Each Cycle is of 28 days Cohort 11.1 SEL 40/60 mg PO once weekly on Days 1, 8, and 15; DEX total 40 mg weekly (IV or PO) single or divided doses on Days 1, 8, 15, and 22; POM 4 mg PO QW Days 1-21; DARA 16 mg/kg IV or SC QW on Days 1, 8, 15 and 22 of Cycles 1-2 and on Days 1 and 15 of Cycles 3-6, Day 1 of every Cycle greater than (\>6). Cohort 11.3 Selinexor, Dexamethasone, Pomalidomide, and Daratumumab will be dosed at RP2D-11.

Drug: Selinexor; Drug: Dexamethasone; Drug: Pomalidomide; Drug: Daratumumab

12. Selinexor + dexamethasone + mezigdomide (SMd)

EXPERIMENTAL

The dose of selinexor will be formally escalated from 40 mg QW to 60 mg QW in combination with mezigdomide 0.6 mg daily. Mezigdomide dosing may be de-escalated as per 3+3 criteria to 0.3 mg or escalated to 1.0 mg. The dose level that passes DLT evaluation will be considered the MTD for the cohort.

Drug: Selinexor; Drug: Dexamethasone; Drug: Mezigdomide

Interventions

Selinexor DRUG

Oral tablets

Also known as: KPT-330, XPOVIO®

10. Selinexor, Dexamethasone, and Belantamab Mafodotin (SBd); 11. Selinexor, Dexamethasone, Pomalidomide, and Daratumumab (SDPd); 12. Selinexor + dexamethasone + mezigdomide (SMd); 1: Selinexor, Low-dose Dexamethasone and Pomalidomide (SPd); 2: Selinexor, Low-dose Dexamethasone and Bortezomib (SVd); 3: Selinexor, Low-dose DEX, and Lenalidomide (SRd) in RRMM; 4:Selinexor, Low-dose dexamethasone, Pomalidomide, Velcade (SPVd); 5: Selinexor, Low-dose dexamethasone, and Daratumumab (SDd); 6: Selinexor, Low-dose dexamethasone, and Carfilzomib (SKd); 7: Selinexor, Low-dose DEX and Lenalidomide (SRd) in NDMM; 8: Selinexor, Low-dose dexamethasone, and Ixazomib (SNd); 9: Selinexor, Low-dose DEX, Pomalidomide and Elotuzumab (SPEd)

Dexamethasone DRUG

Oral tablets

Also known as: Decadron®

10. Selinexor, Dexamethasone, and Belantamab Mafodotin (SBd); 11. Selinexor, Dexamethasone, Pomalidomide, and Daratumumab (SDPd); 12. Selinexor + dexamethasone + mezigdomide (SMd); 1: Selinexor, Low-dose Dexamethasone and Pomalidomide (SPd); 2: Selinexor, Low-dose Dexamethasone and Bortezomib (SVd); 3: Selinexor, Low-dose DEX, and Lenalidomide (SRd) in RRMM; 4:Selinexor, Low-dose dexamethasone, Pomalidomide, Velcade (SPVd); 5: Selinexor, Low-dose dexamethasone, and Daratumumab (SDd); 6: Selinexor, Low-dose dexamethasone, and Carfilzomib (SKd); 7: Selinexor, Low-dose DEX and Lenalidomide (SRd) in NDMM; 8: Selinexor, Low-dose dexamethasone, and Ixazomib (SNd); 9: Selinexor, Low-dose DEX, Pomalidomide and Elotuzumab (SPEd)

Lenalidomide DRUG

Oral capsule

Also known as: Revlimid®

3: Selinexor, Low-dose DEX, and Lenalidomide (SRd) in RRMM; 7: Selinexor, Low-dose DEX and Lenalidomide (SRd) in NDMM

Pomalidomide DRUG

Oral tablets

Also known as: Pomalyst®

11. Selinexor, Dexamethasone, Pomalidomide, and Daratumumab (SDPd); 1: Selinexor, Low-dose Dexamethasone and Pomalidomide (SPd); 4:Selinexor, Low-dose dexamethasone, Pomalidomide, Velcade (SPVd); 9: Selinexor, Low-dose DEX, Pomalidomide and Elotuzumab (SPEd)

Bortezomib DRUG

Subcutaneous Injection (single use vial)

Also known as: Velcade®

2: Selinexor, Low-dose Dexamethasone and Bortezomib (SVd); 4:Selinexor, Low-dose dexamethasone, Pomalidomide, Velcade (SPVd)

Daratumumab DRUG

Intravenous Infusion

Also known as: Darzalex®

11. Selinexor, Dexamethasone, Pomalidomide, and Daratumumab (SDPd); 5: Selinexor, Low-dose dexamethasone, and Daratumumab (SDd)

Carfilzomib DRUG

Intravenous infusion

Also known as: Kyprolis®

6: Selinexor, Low-dose dexamethasone, and Carfilzomib (SKd)

Ixazomib DRUG

Oral capsule

Also known as: Ninlaro®

8: Selinexor, Low-dose dexamethasone, and Ixazomib (SNd)

Elotuzumab DRUG

Intravenous infusion

Also known as: Empliciti®

9: Selinexor, Low-dose DEX, Pomalidomide and Elotuzumab (SPEd)

Clarithromycin DRUG

Tablets

Also known as: Biaxin

4:Selinexor, Low-dose dexamethasone, Pomalidomide, Velcade (SPVd); 6: Selinexor, Low-dose dexamethasone, and Carfilzomib (SKd); 8: Selinexor, Low-dose dexamethasone, and Ixazomib (SNd)

Belantamab Mafodotin DRUG

Intravenous infusion

Also known as: BLENREP

10. Selinexor, Dexamethasone, and Belantamab Mafodotin (SBd)

Mezigdomide DRUG

Oral Capsules

Also known as: BMS-986348, CC-92480

12. Selinexor + dexamethasone + mezigdomide (SMd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent signed in accordance with federal, local, and institutional guidelines.
• Age greater than or equal to (≥) 18 years at the time of informed consent.
• Histologically confirmed diagnosis with measurable disease for relapsed/refractory myeloma.
• Symptomatic MM, based on IMWG guidelines.
• Patients must have measurable disease as defined by at least one of the following:
• Serum M-protein ≥ 0.5 gram per deciliter (g/dL) by serum protein electrophoresis (SPEP) or, for immunoglobulin A (IgA) myeloma, by quantitative IgA
• Urinary M-protein excretion at least 200 mg/24 hours
• Serum free light chain (FLC) ≥ 100 milligram per liter (mg/L), provided that FLC ratio is abnormal
• 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
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
• 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
• 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).

You may not qualify if:

• Smoldering MM.
• MM that does not express M-protein or FLC (i.e., non-secretory MM is excluded), and quantitative immunoglobulin levels cannot be used instead.
• Documented active systemic amyloid light chain amyloidosis.
• Active plasma cell leukemia.
• 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).
• Platelet transfusion or G-CSF within 7 days or pegfilgastrim within 14 days prior to the complete blood count (CBC) used to determine eligibility.
• 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.
• Patients with history of spinal cord compression with residual paraplegia (Dose Escalation Phase only).
• Treatment with an investigational anti-cancer therapy within 3 weeks prior to C1D1.
• Prior autologous stem cell transplantation \< 1 month, or allogeneic stem cell transplantation \< 3 months prior to C1D1.
• Active graft versus host disease after allogeneic stem cell transplantation.
• Life expectancy \< 3 months.
• Major surgery within 4 weeks prior to C1D1.
• Active, unstable cardiovascular function:
• Symptomatic ischemia, or

Sponsors & Collaborators

• Karyopharm Therapeutics Inc: lead
• Bristol-Myers Squibb: collaborator

Study Sites (24)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Jonnsson Comprehensive Cancer Center / University of Los Angeles

Los Angeles, California, 0095, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Wilmot Cancer Center/ University of Rochester

Rochester, New York, United States

Location

University of North Carolina - Chapel Hill Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Duke Institute of Cancer/ Duke University

Durham, North Carolina, 27710, United States

Location

Sarah Cannon- Tennessee Oncology Nashville

Nashville, Tennessee, 37203, United States

Location

Fred Hutch Cancer Center

Seattle, Washington, 98109, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98109, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Tom Baker Cancer Center/Alberta Health Services

Calgary, Alberta, T2N 4Z6, Canada

Location

Cross Cancer Institute / University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Memorial Hospital of Newfoundland

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Royal Victoria Hospital / McGill University

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (3)

• White D, Schiller GJ, Madan S, Lentzsch S, Chubar E, Lavi N, Van Domelen DR, Bentur OS, Baljevic M. Efficacy and safety of once weekly selinexor 40 mg versus 60 mg with pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Front Oncol. 2024 May 17;14:1352281. doi: 10.3389/fonc.2024.1352281. eCollection 2024.

  PMID: 38826786 DERIVED

• Schiller GJ, Lipe BC, Bahlis NJ, Tuchman SA, Bensinger WI, Sutherland HJ, Lentzsch S, Baljevic M, White D, Kotb R, Chen CI, Rossi A, Biran N, LeBlanc R, Grosicki S, Martelli M, Gunsilius E, Spicka I, Stevens DA, Facon T, Mesa MG, Zhang C, Van Domelen DR, Bentur OS, Gasparetto C. Selinexor-Based Triplet Regimens in Patients With Multiple Myeloma Previously Treated With Anti-CD38 Monoclonal Antibodies. Clin Lymphoma Myeloma Leuk. 2023 Sep;23(9):e286-e296.e4. doi: 10.1016/j.clml.2023.06.001. Epub 2023 Jun 5.

  PMID: 37393120 DERIVED

• Bahlis NJ, Sutherland H, White D, Sebag M, Lentzsch S, Kotb R, Venner CP, Gasparetto C, Del Col A, Neri P, Reece D, Kauffman M, Shacham S, Unger TJ, Jeha J, Saint-Martin JR, Shah J, Chen C. Selinexor plus low-dose bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma. Blood. 2018 Dec 13;132(24):2546-2554. doi: 10.1182/blood-2018-06-858852. Epub 2018 Oct 23.

  PMID: 30352784 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

selinexor; Dexamethasone; Calcium Dobesilate; Lenalidomide; pomalidomide; Bortezomib; daratumumab; carfilzomib; ixazomib; elotuzumab; Clarithromycin; belantamab mafodotin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Erythromycin; Macrolides; Polyketides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 21, 2015
• Study Start: October 1, 2015
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (15); CA (9)