This study will independently assess the efficacy and safety of 8 combination therapies in 9 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:
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) 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.
|Trial Phase||Phase 1/2|
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
SPd (Arm 1) Only:
Relapsed and refractory MM with:
SVd (Arm 2) Only:
Relapsed or refractory MM with:
SRd in RRMM (Arm 3) Only:
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).
SPVd (Arm 4) Only:
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).
SDd (Arm 5) Only:
Patients must not have received prior anti-CD38 monoclonal antibodies (Cohort 5.3 ONLY - Dose Expansion at RP2D).
SKd (Arm 6) Only:
Patients may have received prior PIs; however, their MM must NOT be refractory to carfilzomib.
SRd in NDMM (Arm 7) Only:
Patients must have symptomatic myeloma per IMWG guidelines with either CRAB criteria 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.
SNd (Arm 8) Only:
Patients must have MM that relapsed after 1 - 3 prior lines of therapy (may not include those with MM refractory to bortezomib or carfilzomib and patients must be ixazomib-naïve).
SPEd (Arm 9) Only:
Patients meeting any of the following exclusion criteria are not eligible to enroll in this study:
In the 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).
Patients who are eligible for the selinexor PK Run-in only:
Not able to receive a strong CYP3A4 inhibitor due to concomitant medications
SKd Arm only:
The following is a listing of trial locations that are open and accepting patients.
The following is a listing of trial locations that are not currently open and accepting patients.
This trial has active trial locations in countries outside of the United States.
Our system currently only provides clinical trial matching services for myeloma patients in the United States.
You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.
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