OncoMatch/Clinical Trials/NCT02343042
Selinexor and Backbone Treatments of Multiple Myeloma Patients
Is NCT02343042 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for multiple myeloma.
Treatment: Selinexor · Dexamethasone · Lenalidomide · Pomalidomide · Bortezomib · Daratumumab · Carfilzomib · Ixazomib · Elotuzumab · Clarithromycin · Belantamab Mafodotin · Mezigdomide — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: selective inhibitor of nuclear export (sine) compound (selinexor)
Lab requirements
Blood counts
ANC ≥ 1,000/mm^3, hemoglobin ≥ 8.0 g/dL, platelet count ≥ 100,000/mm^3 (with arm-specific exceptions).
Kidney function
Estimated creatinine clearance (CrCl) thresholds vary by arm; see protocol for details.
Liver function
Total bilirubin and AST/ALT thresholds vary by arm; see protocol for details.
Cardiac function
No symptomatic ischemia, uncontrolled conduction abnormalities, CHF NYHA Class ≥ 3, MI within 3 months, or EF < 50% (Arms 1-11 only).
Adequate hepatic, renal, and hematopoietic function within 28 days prior to C1D1; cardiac function as specified.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- Jonnsson Comprehensive Cancer Center / University of Los Angeles · Los Angeles, California
- Sarah Cannon-Colorado Blood Cancer Institute · Denver, Colorado
- Massachusetts General Hospital · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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