Multiple MyelomaPhase 2NCT05820763
Selinexor and Lenalidomide for Consolidation and Maintenance Treatment in Multiple Myeloma Post-transplant
A Phase 2 study testing Selinexor, Lenalidomide and Dexamethasone in people with Multiple Myeloma and Myeloma-Associated Amyloidosis, run by Washington University School of Medicine.
Trial summary
This phase II clinical trial studies the addition of selinexor to lenalidomide in patients with multiple myeloma following transplant. Selinexor is an oral medication approved for use in patients with multiple myeloma following failure of other regimens, and lenalidomide is an oral medication approved for use in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Myeloma-Associated Amyloidosis
- What is being tested?
- Selinexor, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2024to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age at time of enrollment.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- Histologically confirmed diagnosis of multiple myeloma that is symptomatic. Patients with multiple myeloma with local amyloid deposition in the bone marrow are eligible.
- Patients must have undergone lenalidomide-based induction regimen.
- Patient must have undergone AHCT within 80 to 140 days prior to C1D1 for MM.
- Patient must be MRD-positive (per 10^-5 threshold) using clonoSEQ MRD® assay on bone marrow biopsy prior to study enrollment.
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- Patient must have achieved very good partial response or better per IMWG response criteria prior to study enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
- Adequate organ function as defined below:
- Absolute neutrophil count (ANC) ≥ 1.5 K/cumm.
- Platelet count ≥ 100 K/cumm (patients for whom <50% of bone marrow nucleated cells are plasma cells) or ≥50 K/cumm (patients for whom ≥50% of bone marrow nucleated cells are plasma cells).; platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days before C1D1.
- Hemoglobin ≥ 8.5 g/dL without blood transfusion within 7 days before C1D1.
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN), patients with Gilbert's syndrome must have a total bilirubin of < 3 x ULN.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN.
- Calculated creatinine clearance ≥ 15 mL/min per Cockcroft and Gault formula.
- Women of childbearing potential must follow pregnancy testing requirements as outlined in the Revlimid REMS® program material. This is defined as either committing to continued abstinence from heterosexual intercourse or beginning TWO acceptable methods of contraception (one highly effective method and one additional effective method AT THE SAME TIME) at least 28 days prior to the start of lenalidomide, for the duration of study participation, and for 28 days following the last dose of lenalidomide. Women of childbearing potential must also agree to ongoing pregnancy testing.
- Men must agree to use a latex condom during sexual contact with a woman of childbearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- All study participants must be registered into the mandatory Revlimid REMS® program and be willing to comply with its requirements. Per standard Revlimid REMS® program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS® program.
Who cannot join
- Patients with lenalidomide-refractory disease during induction.
- Prior receipt of selinexor or another XPO1 inhibitor previously.
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Evidence of MM disease progression any time prior to enrollment. Progression from smoldering/asymptomatic MM to symptomatic MM is not exclusionary.
- Tandem autologous transplantation.
- History of plasma cell leukemia or MM CNS involvement.
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- Administration or planned administration of any other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy which would be considered a treatment of multiple myeloma from Day +28 post-transplant through discontinuation from study. Patients may be on corticosteroids if they are being given for disorders other than multiple myeloma (e.g., adrenal insufficiency, rheumatoid arthritis, etc.).
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Prior organ transplant requiring immunosuppressive therapy.
- Subjects with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 IU/ml prior to first dose of trial treatment. Subjects with untreated hepatitis C virus (HCV) are allowed. Subjects with Human Immunodeficiency Virus (HIV) who have CD4+ T-cell counts ≥ 350 cells/µL and no history of AIDS-defining opportunistic infections in the last year are allowed.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
- Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
- Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma with local amyloid deposition in the bone marrow).
- Active, unstable cardiovascular function, as indicated by the presence of:
- Symptomatic ischemia, or
- Uncontrolled clinically significant conduction abnormalities (e.g. patients with ventricular tachycardia on anti-arrhythmics are excluded; patients with first degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block will not be excluded), or
- Congestive heart failure of NYHA Class ≥3 or known left ventricular ejection fraction of <40%, or
- Myocardial infarction within 3 months prior to C1D1.
- Grade > 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
- Major surgery within 14 days prior to C1D1.
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1. Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
- Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days prior to C1D1 and throughout the duration of this trial.
About this study
Official title: A Phase II Study of Selinexor In Addition to Lenalidomide for Consolidation and Maintenance Treatment After Autologous Hematopoietic Cell Transplant in Multiple Myeloma
This phase II clinical trial studies the addition of selinexor to lenalidomide in patients with multiple myeloma following transplant. Selinexor is an oral medication approved for use in patients with multiple myeloma following failure of other regimens, and lenalidomide is an oral medication approved for use in patients with multiple myeloma following transplant. This study is testing if the combination of selinexor and lenalidomide is more effective than lenalidomide alone in this setting.
- Conditions
- Multiple Myeloma, Myeloma-Associated Amyloidosis
- Being tested
- Selinexor, Lenalidomide, Dexamethasone
- Keywords
- symptomatic multiple myeloma, myeloma post-AHCT, myeloma post-transplant, Multiple myeloma with amyloid deposition, Multiple Myeloma, post-transplant maintenance, Minimal residual disease
- Medical subject headings
- Multiple Myeloma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called EXPOVIO, KPT-330
Selinexor is administered by mouth on Days 1, 8, 15, and 22 at a dose of 60 mg during the four cycles of consolidation. Selinexor is then decreased to 40 mg and administered by mouth on Days 1, 8, 15, and 22 for up to 8 cycles of maintenance therapy.
LenalidomideDrug
Also called Revlimid
Lenalidomide is administered by mouth daily on Days 1 to 21 at a dose of 10 mg during the first three cycles of consolidation, and then titrated up to 15 mg on Days 1 to 21 for the fourth cycle of consolidation. Lenalidomide 15 mg by mouth daily on Days 1 to 21 can be continued for up to 8 cycles of maintenance therapy.
For patients with baseline renal dysfunction, the starting dose of lenalidomide will be 2.5 mg or 5 mg by mouth daily on Days 1 to 21. Patients may titrate up per physician discretion.
DexamethasoneDrug
Also called Decadron
Dexamethasone is administered by mouth on Days 1, 8, 15, and 22 at a dose of 20 mg during all four cycles of consolidation only.
| Study group | Role | What they receive |
|---|---|---|
| Consolidation: Selinexor, Lenalidomide, and Dexamethasone | Experimental | Consolidation will begin between Days 80 and 140 following standard of care autologous hematopoietic stem cell transplant and the treatment will consist of selinexor, lenalidomide, and dexamethasone for 4 28-day cycles. Receives: Drug: Selinexor; Drug: Lenalidomide; Drug: Dexamethasone |
| Maintenance: Selinexor and Lenalidomide | Experimental | Maintenance will consist of selinexor and lenalidomide for a maximum of 8 28-day cycles. Receives: Drug: Selinexor; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Minimal Residual Disease (MRD) negativity
Defined by rate of MRD negativity using clonoSEQ MRD® assay at a sensitivity of 10^-5. MRD negativity is defined as 0 residual clonal cells in a bone marrow biopsy sample.
Measured: At the end of consolidation treatment (at the end of 4 cycles (each cycle is 28 days)
Rate of Minimal Residual Disease (MRD) negativity
Defined by rate of MRD negativity using clonoSEQ MRD® assay at a sensitivity of 10^-5. MRD negativity is defined as 0 residual clonal cells in a bone marrow biopsy sample.
Measured: 12 months from study treatment initiation
Secondary outcomes (2)
Rate of partial response or better
Defined as the rate of patients achieving a partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR), as defined by standard IMWG response criteria.
Measured: 12 months from study treatment initiation
Progression-free survival (PFS)
PFS will be defined as time from AHCT to progression, relapse, or death, whichever occurs first, and those event-free survivors will be censored at withdrawal or study closeout
Measured: 12 months from study treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start5 Jan 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Why it stopped: Study sponsor decided to close study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Patients will initially receive 4 cycles of consolidation triplet therapy followed by 8 cycles of maintenance doublet therapy.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Karyopharm Therapeutics Inc
- Responsible party
- Sponsor
- Investigators
- Mark Schroeder, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820763
- Sponsor's protocol ID
- 202306068
- Status last verified
- Jul 2024
- First submitted
- 6 Apr 2023
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results of the publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Selinexor In Addition to Lenalidomide for Consolidation and Maintenance Treatment After Autologous Hematopoietic Cell Transplant in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05820763
- Acronym / sponsor ID
- 202306068
- Conditions
- Multiple Myeloma, Myeloma-Associated Amyloidosis
- Keywords
- symptomatic multiple myeloma, myeloma post-AHCT, myeloma post-transplant, Multiple myeloma with amyloid deposition, Multiple Myeloma, post-transplant maintenance, Minimal residual disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study sponsor decided to close study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Karyopharm Therapeutics Inc
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II clinical trial studies the addition of selinexor to lenalidomide in patients with multiple myeloma following transplant. Selinexor is an oral medication approved for use in patients with multiple myeloma following failure of other regimens, and lenalidomide is an oral medication approved for use in patients with multiple myeloma following transplant. This study is testing if the combination of selinexor and lenalidomide is more effective than lenalidomide alone in this setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will initially receive 4 cycles of consolidation triplet therapy followed by 8 cycles of maintenance doublet therapy.
| Arm | Type | Receives |
|---|---|---|
| Consolidation: Selinexor, Lenalidomide, and Dexamethasone | Experimental | Drug: Selinexor, Drug: Lenalidomide, Drug: DexamethasoneConsolidation will begin between Days 80 and 140 following standard of care autologous hematopoietic stem cell transplant and the treatment will consist of selinexor, lenalidomide, and dexamethasone for 4 28-day cycles. |
| Maintenance: Selinexor and Lenalidomide | Experimental | Drug: Selinexor, Drug: LenalidomideMaintenance will consist of selinexor and lenalidomide for a maximum of 8 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients ≥18 years of age at time of enrollment.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- Histologically confirmed diagnosis of multiple myeloma that is symptomatic. Patients with multiple myeloma with local amyloid deposition in the bone marrow are eligible.
- Patients must have undergone lenalidomide-based induction regimen.
- Patient must have undergone AHCT within 80 to 140 days prior to C1D1 for MM.
Key exclusion criteria (23 listed)
- Patients with lenalidomide-refractory disease during induction.
- Prior receipt of selinexor or another XPO1 inhibitor previously.
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Evidence of MM disease progression any time prior to enrollment. Progression from smoldering/asymptomatic MM to symptomatic MM is not exclusionary.
- Tandem autologous transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelinexorAlso: EXPOVIO, KPT-330Selinexor is administered by mouth on Days 1, 8, 15, and 22 at a dose of 60 mg during the four cycles of consolidation. Selinexor is then decreased to 40 mg and administered by mouth on Days 1, 8, 15, and 22 for up to 8 cycles of maintenance therapy. | Drug | Consolidation: Selinexor, Lenalidomide, and Dexamethasone, Maintenance: Selinexor and Lenalidomide |
| LenalidomideAlso: RevlimidLenalidomide is administered by mouth daily on Days 1 to 21 at a dose of 10 mg during the first three cycles of consolidation, and then titrated up to 15 mg on Days 1 to 21 for the fourth cycle of consolidation. Lenalidomide 15 mg by mouth daily on Days 1 to 21 can be continued for up to 8 cycles of maintenance therapy. For patients with baseline renal dysfunction, the starting dose of lenalidomide will be 2.5 mg or 5 mg by mouth daily on Days 1 to 21. Patients may titrate up per physician discretion. | Drug | Consolidation: Selinexor, Lenalidomide, and Dexamethasone, Maintenance: Selinexor and Lenalidomide |
| DexamethasoneAlso: DecadronDexamethasone is administered by mouth on Days 1, 8, 15, and 22 at a dose of 20 mg during all four cycles of consolidation only. | Drug | Consolidation: Selinexor, Lenalidomide, and Dexamethasone |
Primary outcome
Rate of Minimal Residual Disease (MRD) negativity
Time frame: At the end of consolidation treatment (at the end of 4 cycles (each cycle is 28 days)
Defined by rate of MRD negativity using clonoSEQ MRD® assay at a sensitivity of 10^-5. MRD negativity is defined as 0 residual clonal cells in a bone marrow biopsy sample.
Rate of Minimal Residual Disease (MRD) negativity
Time frame: 12 months from study treatment initiation
Defined by rate of MRD negativity using clonoSEQ MRD® assay at a sensitivity of 10^-5. MRD negativity is defined as 0 residual clonal cells in a bone marrow biopsy sample.
2 secondary outcomes
Rate of partial response or better
Time frame: 12 months from study treatment initiation
Progression-free survival (PFS)
Time frame: 12 months from study treatment initiation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results of the publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Schroeder, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selinexor, Lenalidomide and Dexamethasone in people with Multiple Myeloma and Myeloma-Associated Amyloidosis, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Minimal Residual Disease (MRD) negativity (time frame: At the end of consolidation treatment (at the end of 4 cycles (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.