NCT02343042 · Karyopharm Therapeutics Inc
Selinexor and Backbone Treatments of Multiple Myeloma Patients
(STOMP)
What this study is about
This study will independently assess the effectiveness and safety of 11 combination therapies in 12 treatment group$1, in gradually increasing doses/-evaluation and expansion phases, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM).
View original scientific 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).
Interventions
DRUG
Selinexor
Oral tablets
DRUG
Dexamethasone
Oral tablets
DRUG
Lenalidomide
Oral capsule
DRUG
Pomalidomide
Oral tablets
DRUG
Bortezomib
Subcutaneous Injection (single use vial)
DRUG
Daratumumab
Intravenous Infusion
DRUG
Carfilzomib
Intravenous infusion
DRUG
Ixazomib
Oral capsule
DRUG
Elotuzumab
Intravenous infusion
DRUG
Clarithromycin
Tablets
DRUG
Belantamab Mafodotin
Intravenous infusion
DRUG
Mezigdomide
Oral Capsules
Primary outcome measures
Phase 1 (Dose-escalation): Maximum Tolerated Dose (MTD)
Time frame: 12 months
MTD for once weekly and twice weekly selinexor dose cohorts in the 11 Arms will be evaluated.
Phase 1 (Dose-escalation): Recommended Phase-2 dose (RP2D)
Time frame: 12 months
RP2D for each Arm will be determined.
Phase 1 (Dose-escalation): Maximum Plasma Concentration (Cmax) of Selinexor
Time frame: 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)
Cmax of selinexor over a dosing interval when given with and without clarithromycin.
Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor
Time frame: 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)
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.
Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf)
Time frame: 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)
Time frame: 12 months
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.
Phase 2 (Expansion): Duration of response (DOR)
Time frame: 12 months
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.
Phase 2 (Expansion): Clinical Benefit Rate (CBR)
Time frame: 12 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 neuropath
Where
- Gilbert, Arizona
- Los Angeles, California
- Denver, Colorado
- Boston, Massachusetts
- Omaha, Nebraska
- Hackensack, New Jersey
- New York, New York
- Rochester, New York
- Chapel Hill, North Carolina
- Durham, North Carolina
- Nashville, Tennessee
- Seattle, Washington
And 1 more location — see the full list below.
Collaborators
Bristol-Myers Squibb
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations