Multiple MyelomaPhase 1NCT02831686

A Study to Test the Combination of Selinexor (KPT-330), Ixazomib, and Dexamethasone in Patients With Myeloma

A Phase 1 study testing Selinexor, Ixazomib and Dexamethasone in people with Multiple Myeloma and Relapsed and/or Refractory Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma, Relapsed and/or Refractory Multiple Myeloma
What is being tested?: Selinexor, Ixazomib and Dexamethasone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 7 sitesUnited States
Study dates: Jul 2016to 19 Nov 2020
Phase: Phase 1
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

MSKCC confirmed diagnosis of multiple myeloma that has relapsed or is resistant after therapy with at least one immunomodulatory drug (i.e. lenalidomide, thalidomide) and at least one proteasome inhibitor.
Measurable multiple myeloma disease, defined as meeting at least 1 of the following criteria within 14 days prior to registration:
A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 0.5 g/dL.
Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
Involved serum free light chain (FLC) level ≥ 10 mg/dL, provided the serum FLC ratio is abnormal.
Presence of extramedullary plasmacytomas.

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Patient must be ≥ 18 years of age at time of informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to registration.
Adequate hematology laboratory values within 14 days prior to registration:
Neutrophils ≥ 1.0 × 10^9/L (growth factor support is not allowed).
Platelet count ≥75x10^9/L. Platelet support is permitted within 14 days although platelet transfusions to help participants meet eligibility criteria are not allowed within 72 hours (3 days) prior to the blood sample to confirm protocol eligibility.
Adequate hepatic and renal function laboratory values within 14 days prior to registration:
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 3 × the upper limit of normal (ULN).
Total bilirubin ≤ 1.5 mg/dL except for patients with a history of elevated total bilirubin, such as in Gilbert's.
Calculated (Cockcroft and Gault formula) or measured creatinine clearance ≥ 30mL/min.
Left ventricular ejection fraction (LVEF) ≥ 40% within 28 days prior to registration, evaluated by 2-D transthoracic echocardiogram (ECHO) or, if ECHO is not available, by multi-gated acquisition (MUGA) scan.
Female patients who:
Are postmenopausal for at least 1 year before the screening visit, OR
Are surgically sterile, OR
If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)If patient is female and of childbearing potential, she must have a negative serum beta human chorionic gonadotropin (β-HCG) test within 14 days prior to registration and consent to ongoing pregnancy testing during the course of the study.
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment.
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Written informed consent in accordance with federal, local, and institutional guidelines. The patients must provide informed consent prior to the first screening procedure.

Who cannot join

Female patients who are lactating or have a positive serum pregnancy test during the screening period.
Failure to have fully recovered from the reversible effects of prior anti-cancer therapy.
Major surgery within 14 days prior to the first dose of study drug.
Radiotherapy within 14 days prior to the first dose of study drug. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the first dose of the study medications.
Disease-related central nervous system involvement.
The subject has uncontrolled significant intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris within 6 months, stroke within 6 months, myocardial infarction within 6 months, or uncontrolled cardiac arrhythmias, uncontrolled hypertension.

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Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Known GI disease or GI procedure that could interfere with the oral absorption of study medication including difficulty swallowing.
Concurrent malignancy except for treated non-melanoma skin cancer, cervical carcinoma in situ and low-risk prostate CA being monitored without treatment.
Patient has Grade 3 peripheral neuropathy or Grade 2 with pain on clinical examination during the screening period.
Chemotherapy within 14 days of the start of this trial.
Prior exposure to a SINE compound.
Patients unwilling to comply with the protocol.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553

Other trials in United States

About this study

Official title: An Investigator-Initiated Phase I Study of Selinexor (KPT-330), Ixazomib, and Low Dose Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to test the safety of a combination of study drugs called selinexor (KPT-330) and ixazomib (MLN9708) with a low dose of dexamethasone. This study tests different doses of the study drug, selinexor to see which dose is safer in people. Depending on which group (dose level) you are in, the dose of selinexor will vary, but the ixazomib and dexamethasone doses will be the same among the groups.

Conditions: Multiple Myeloma, Relapsed and/or Refractory Multiple Myeloma
Being tested: Selinexor, Ixazomib, Dexamethasone
Keywords: Selinexor (KPT-330), Ixazomib, dexamethasone, 15-310
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SelinexorDrug
Also called (KPT-330)
IxazomibDrug
DexamethasoneDrug

Study groups in NCT02831686
Study group	Role	What they receive
Selinexor (KPT-330), Ixazomib, and Dexamethasone	Experimental	Patients with relapsed and/or refractory MM will be treated with ixazomib, selinexor, and dexamethasone, all of which will be administered orally.Ixazomib will be given on Days 1, 8, and 15 on a 28 day cycle. Selinexor will be given twice weekly for three weeks, then there will be 1 week off (Days 1,3, 8,10, 15, 17) This study will follow a 3-by-3 dose escalation design. Dexamethasone will be given on all days of Selinexor but will also be given on the week off from Selinexor (Days 1, 3, 8, 10,15, 17, 22, 24). Receives: Drug: Selinexor; Drug: Ixazomib; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

maximum tolerated dose (MTD)
This study will follow a 3-by-3 dose escalation design.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201619 Nov 2020

First posted13 Jul 2016 (estimated)
Study startJul 2016
Primary completion19 Nov 2020
Study completion19 Nov 2020

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 Memorial Sloan Kettering Cancer CenterThe 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02831686
Sponsor's protocol ID: 15-310
Status last verified: Nov 2020
First submitted: 11 Jul 2016
Last updated: 24 Nov 2020
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Investigator-Initiated Phase I Study of Selinexor (KPT-330), Ixazomib, and Low Dose Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT02831686
Acronym / sponsor ID: 15-310
Conditions: Multiple Myeloma, Relapsed and/or Refractory Multiple Myeloma
Keywords: Selinexor (KPT-330), Ixazomib, dexamethasone, 15-310
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
Collaborators: Karyopharm Therapeutics Inc, Millennium Pharmaceuticals, Inc.
Study start: Jul 2016 (actual)
Primary completion: 19 Nov 2020 (actual)
Study completion: 19 Nov 2020 (actual)
First posted: 13 Jul 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Selinexor (KPT-330), Ixazomib, and Dexamethasone	Experimental	Drug: Selinexor, Drug: Ixazomib, Drug: DexamethasonePatients with relapsed and/or refractory MM will be treated with ixazomib, selinexor, and dexamethasone, all of which will be administered orally.Ixazomib will be given on Days 1, 8, and 15 on a 28 day cycle. Selinexor will be given twice weekly for three weeks, then there will be 1 week off (Days 1,3, 8,10, 15, 17) This study will follow a 3-by-3 dose escalation design. Dexamethasone will be given on all days of Selinexor but will also be given on the week off from Selinexor (Days 1, 3, 8, 10,15, 17, 22, 24).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (27 listed)

MSKCC confirmed diagnosis of multiple myeloma that has relapsed or is resistant after therapy with at least one immunomodulatory drug (i.e. lenalidomide, thalidomide) and at least one proteasome inhibitor.
Measurable multiple myeloma disease, defined as meeting at least 1 of the following criteria within 14 days prior to registration:
Patient must be ≥ 18 years of age at time of informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to registration.
Adequate hematology laboratory values within 14 days prior to registration:

Key exclusion criteria (15 listed)

Female patients who are lactating or have a positive serum pregnancy test during the screening period.
Failure to have fully recovered from the reversible effects of prior anti-cancer therapy.
Major surgery within 14 days prior to the first dose of study drug.
Radiotherapy within 14 days prior to the first dose of study drug. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the first dose of the study medications.
Disease-related central nervous system involvement.

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: (KPT-330)	Drug	Selinexor (KPT-330), Ixazomib, and Dexamethasone
Ixazomib	Drug	Selinexor (KPT-330), Ixazomib, and Dexamethasone
Dexamethasone	Drug	Selinexor (KPT-330), Ixazomib, and Dexamethasone

Primary outcome

maximum tolerated dose (MTD)
Time frame: 1 year
This study will follow a 3-by-3 dose escalation design.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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.

Malin Hultcrantz, MD, PhD principal investigator

Memorial Sloan Kettering Cancer Center

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 27 inclusion and 15 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: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

maximum tolerated dose (MTD) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02831686.

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 24 Nov 2020.