Plasma Cell MyelomaPhase 2NCT02389517
Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant
A Phase 2 study testing Ixazomib Citrate, Lenalidomide and Dexamethasone in people with Plasma Cell Myeloma and Residual Disease, run by University of Chicago at 1 site in United States.
Trial summary
This randomized phase II trial studies how well lenalidomide alone compared to lenalidomide, ixazomib citrate, and dexamethasone work in treating patients with multiple myeloma that remains (residual) after donor stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Myeloma, Residual Disease
- What is being tested?
- Ixazomib Citrate, Lenalidomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2015to Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 who completed induction treatment followed by autologous stem cell transplant as initial therapy for symptomatic myeloma as per IMWG criteria and initiated Revlimid (lenalidomide) maintenance
- Patients must have initiated lenalidomide maintenance at approximately 3 months post autologous stem transplant (preferably 70-90 but not more than 120 days)
- Patients must be receiving lenalidomide 10 mg or 15 mg and be able to tolerate dose escalation to 25 mg daily
- Patients must have received lenalidomide maintenance for 3 months (+1 month window for a maximum of 4 months lenalidomide prior to enrollment)
- No evidence of progressive disease on lenalidomide
- Any measurable residual disease at the time of screening for the study documented in at least one of the following ways:
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- Serum protein electrophoresis (SPEP)/immunofixation studies (IFIX) positive disease
- Freelite only positive disease
- SPEP/IFIX - negative and Freelite- negative but MRD-positive disease is allowed
- Evidence of MRD at the time of screening for this study by multi-color flow cytometry (bone marrow procedure at screening required)
- Bone marrow specimen will be required at study entry; available deoxyribonucleic acid (DNA) sample will be used for calibration step for MRD evaluation by gene sequencing
- Life expectancy of more than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Bilirubin =<1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN
- Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
- Hemoglobin >= 8 g/dL
- Platelet count >= 75 x 10^9/L
- Calculated creatinine clearance (by Cockroft-Gault) >= 50 ml/min or serum creatinine below 2 g/dL
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- 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)
- 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)
Who cannot join
- Evidence of progressive disease on lenalidomide maintenance as per IMWG criteria
- Patients who have already started or received multi-drug consolidation regimen post-transplant expect for lenalidomide maintenance
- Diarrhea > grade 1 in the absence of anti-diarrheals
- Central nervous system involvement
- Female patients who are lactating or have a positive serum pregnancy test during the screening period
- History of allergy to mannitol
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- Major surgery within 14 days before enrollment
- Radiotherapy within 14 days before randomization; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled cardiac conditions such as hypertension, or cardiac arrhythmias, or New York Heart Association stage III and IV congestive heart failure, or unstable angina or myocardial infarction within the past 6 months
- Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12-lead electrocardiogram (ECG) during screening
- Uncontrolled diabetes
- Acute infection requiring systemic anti-infectives, antivirals, or antifungals within two weeks prior to first dose
- Systemic treatment, within 14 days before the first dose of ixazomib, with strong inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 2 (CYP1A2) (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of cytochrome P450 family 3, subfamily A CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort
- Ongoing or active systemic infection, 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 gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
- Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
- Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
- Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomized Trial of Continuation of Post-Transplant Maintenance With Single-Agent Lenalidomide vs. Consolidation/Maintenance With Ixazomib-Lenalidomide-Dexamethasone in Patients With Residual Myeloma
This randomized phase II trial studies how well lenalidomide alone compared to lenalidomide, ixazomib citrate, and dexamethasone work in treating patients with multiple myeloma that remains (residual) after donor stem cell transplant. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells and may also prevent the growth of new blood vessels that are needed for cancer growth. Ixazomib citrate may stop the growth of cancer cells by interfering with proteins necessary for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide is more effective with or without ixazomib citrate and dexamethasone in treating residual multiple myeloma.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the rate of minimal residual disease (MRD)-negative disease by multiparameter-flow cytometry at 12 months after randomization.
SECONDARY OBJECTIVES:
- Evidence of response as demonstrated by the improvement of the depth of response by at least one category according to International Myeloma Working Group (IMWG) response criteria.
II. Progression free survival (PFS). III. Overall survival (OS). IV. Duration of MRD-negative disease. V. Safety and tolerability of experimental arm (ixazomib citrate, lenalidomide, and low dose dexamethasone [IRd]) vs. control arm (lenalidomide [Rd]).
TERTIARY OBJECTIVES:
- Determination of markers of response based on pre-treatment characteristics using methods described in correlative research.
II. Evaluation of MRD by gene sequencing method using the Sequenta platform (LymphoSIGHT®) in parallel with multi-parameter flow cytometry (MFC).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15, lenalidomide PO once daily (QD) on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
ARM II: Patients receive lenalidomide PO as in Arm I.
In both arms, treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After the completion of treatment, patients are followed up at 30 days and then every 3 months for 2 years.
- Conditions
- Plasma Cell Myeloma, Residual Disease
- Being tested
- Ixazomib Citrate, Lenalidomide, Dexamethasone
- 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.
Ixazomib CitrateDrug
Also called MLN-9708, MLN9708, proteasome inhibitor MLN9708
Given PO
LenalidomideDrug
Also called CC-5013, CC5013, CDC 501, IMiD-1
Given PO
DexamethasoneDrug
Also called DM
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ixazomib citrate, lenalidomide, dexamethasone) | Experimental | Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only). Receives: Drug: Ixazomib Citrate; Drug: Lenalidomide; Drug: Dexamethasone |
| Arm II (lenalidomide) | Active comparator | Patients receive lenalidomide PO as in Arm I. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With MRD Negativity
Rate of MRD negativity after 12 months of treatment with Ixazomib in combination with lenalidomide and dexamethasone compared to MRD negativity rate after 12 months of lenalidomide alone. For the majority of patients, where MRD positivity at screening will be determined by Multi-parameter Flow Cytometry (MFC), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by MFC. Additionally, in the fraction of patients with MRD-negative disease by MFC at screening, who were MRD-positive by Next Generation Sequencing (NGS), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by NGS
Measured: At 12 months
Secondary outcomes (6)
Overall Response (Number of Participants With VGPR, CR, sCR)
Overall response was defined according to IMWG criteria as
- very good partial response (VGPR)
- complete response (CR)
- stringent complete response (sCR)
Measured: At 6 months
Duration of MRD-negative Disease
Duraion of MRD-negativie disease was defined as the duration from the date of MRD negative to the date of diseae progression or date of last clinical follow up.
Measured: every 28 days, up to 2 years
Progression Free Survival
Time to event will be estimated using the product-limit method of Kaplan and Meier.
Measured: up to 2 years
Overall Survival
OS is the time from randomization date to death date. Participants who have not died will be censored on the last date they are known to be alive.
Measured: Up to 2 years
Number of Patients With Adverse Events
Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Measured: Up to 30 days post-treatment, **up to 2 years**
Overall Response (Number of Participants With VGPR, CR, sCR)
Overall response was defined according to IMWG criteria as
- very good partial response (VGPR)
- complete response (CR)
- stringent complete response (sCR)
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start2 Mar 2015
- Primary completionFeb 2021
- Study completionJan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Multiple Myeloma Research Foundation
- Responsible party
- Sponsor
- Investigators
- Andrzej Jakubowiak, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389517
- Sponsor's protocol ID
- IRB14-0899
- Other IDs
- NCI-2015-00138, X16047, 14-0899, IRB14-0899, P30CA014599
- Status last verified
- Jan 2026
- First submitted
- 10 Mar 2015
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial of Continuation of Post-Transplant Maintenance With Single-Agent Lenalidomide vs. Consolidation/Maintenance With Ixazomib-Lenalidomide-Dexamethasone in Patients With Residual Myeloma
- ClinicalTrials.gov ID
- NCT02389517
- Acronym / sponsor ID
- IRB14-0899
- Conditions
- Plasma Cell Myeloma, Residual Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Multiple Myeloma Research Foundation
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Jan 2024 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well lenalidomide alone compared to lenalidomide, ixazomib citrate, and dexamethasone work in treating patients with multiple myeloma that remains (residual) after donor stem cell transplant. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells and may also prevent the growth of new blood vessels that are needed for cancer growth. Ixazomib citrate may stop the growth of cancer cells by interfering with proteins necessary for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide is more effective with or without ixazomib citrate and dexamethasone in treating residual multiple myeloma.
Detailed description
PRIMARY OBJECTIVES:
- To determine the rate of minimal residual disease (MRD)-negative disease by multiparameter-flow cytometry at 12 months after randomization.
SECONDARY OBJECTIVES:
- Evidence of response as demonstrated by the improvement of the depth of response by at least one category according to International Myeloma Working Group (IMWG) response criteria.
II. Progression free survival (PFS). III. Overall survival (OS). IV. Duration of MRD-negative disease. V. Safety and tolerability of experimental arm (ixazomib citrate, lenalidomide, and low dose dexamethasone [IRd]) vs. control arm (lenalidomide [Rd]).
TERTIARY OBJECTIVES:
- Determination of markers of response based on pre-treatment characteristics using methods described in correlative research.
II. Evaluation of MRD by gene sequencing method using the Sequenta platform (LymphoSIGHT®) in parallel with multi-parameter flow cytometry (MFC).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15, lenalidomide PO once daily (QD) on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
ARM II: Patients receive lenalidomide PO as in Arm I.
In both arms, treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After the completion of treatment, patients are followed up at 30 days and then every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ixazomib citrate, lenalidomide, dexamethasone) | Experimental | Drug: Ixazomib Citrate, Drug: Lenalidomide, Drug: DexamethasonePatients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only). |
| Arm II (lenalidomide) | Active comparator | Drug: LenalidomidePatients receive lenalidomide PO as in Arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Patients who completed induction treatment followed by autologous stem cell transplant as initial therapy for symptomatic myeloma as per IMWG criteria and initiated Revlimid (lenalidomide) maintenance
- No evidence of progressive disease on lenalidomide
- Any measurable residual disease at the time of screening for the study documented in at least one of the following ways:
- Evidence of MRD at the time of screening for this study by multi-color flow cytometry (bone marrow procedure at screening required)
- Bone marrow specimen will be required at study entry; available deoxyribonucleic acid (DNA) sample will be used for calibration step for MRD evaluation by gene sequencing
Key exclusion criteria (20 listed)
- Evidence of progressive disease on lenalidomide maintenance as per IMWG criteria
- Patients who have already started or received multi-drug consolidation regimen post-transplant expect for lenalidomide maintenance
- Diarrhea > grade 1 in the absence of anti-diarrheals
- Central nervous system involvement
- Female patients who are lactating or have a positive serum pregnancy test during the screening period
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 |
|---|---|---|
| Ixazomib CitrateAlso: MLN-9708, MLN9708, proteasome inhibitor MLN9708Given PO | Drug | Arm I (ixazomib citrate, lenalidomide, dexamethasone) |
| LenalidomideAlso: CC-5013, CC5013, CDC 501, IMiD-1Given PO | Drug | Arm I (ixazomib citrate, lenalidomide, dexamethasone), Arm II (lenalidomide) |
| DexamethasoneAlso: DMGiven PO | Drug | Arm I (ixazomib citrate, lenalidomide, dexamethasone) |
Primary outcome
Percentage of Participants With MRD Negativity
Time frame: At 12 months
Rate of MRD negativity after 12 months of treatment with Ixazomib in combination with lenalidomide and dexamethasone compared to MRD negativity rate after 12 months of lenalidomide alone. For the majority of patients, where MRD positivity at screening will be determined by Multi-parameter Flow Cytometry (MFC), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by MFC. Additionally, in the fraction of patients with MRD-negative disease by MFC at screening, who were MRD-positive by Next Generation Sequencing (NGS), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by NGS
6 secondary outcomes
Overall Response (Number of Participants With VGPR, CR, sCR)
Time frame: At 6 months
Duration of MRD-negative Disease
Time frame: every 28 days, up to 2 years
Progression Free Survival
Time frame: up to 2 years
Overall Survival
Time frame: Up to 2 years
Number of Patients With Adverse Events
Time frame: Up to 30 days post-treatment, **up to 2 years**
Overall Response (Number of Participants With VGPR, CR, sCR)
Time frame: At 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrzej Jakubowiak principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixazomib Citrate, Lenalidomide and Dexamethasone in people with Plasma Cell Myeloma and Residual Disease, run by University of Chicago at 1 site in United States.
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 28 inclusion and 20 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With MRD Negativity (time frame: At 12 months). 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 22 Jan 2026.