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Multiple Myeloma in RelapsePhase 2IPoD-790NCT04790474

Ixazomib-pomalidomide-dexamethasone as Second or Third-line Combination Treatment for Patients With Relapsed and Refractory Multiple Myeloma Previously Treated With Daratumumab, Lenalidomide and Bortezomib

A Phase 2 study testing ixazomib-pomalidomide-dexamethasone in people with Multiple Myeloma in Relapse and Refractory Multiple Myeloma, run by Tel-Aviv Sourasky Medical Center at 7 sites in Israel.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Adult patients with a confirmed diagnosis of symptomatic and relapsed and/or refractory MM, after receiving bortezomib, lenalidomide and daratumumab during first and second lines, will be eligible to be enrolled in this study. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ixazomib-pomalidomide-dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
7 sitesIsrael
Study dates
25 Mar 2021to 1 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 must meet all of the following inclusion criteria:
  • Male or female patients, 18 years of age or older.
  • Multiple myeloma diagnosed according to standard IMWG criteria
  • Patients must have measurable disease defined by at least one of the following five measurements:
  • Serum M-protein 1 g/dL (10 g/L).
  • Urine M-protein 200 mg/24 hours.
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  • Serum free light chain assay: involved free light chain level at least 100 mg/L), provided that the serum free light chain ratio is abnormal.
  • A biopsy proven evaluable plasmacytoma
  • Bone marrow plasmacytosis > 30% of total marrow cells
  • Patients received one or two prior lines of therapy which must have included bortezomib, lenalidomide-and daratumumab.
  • Patients must meet the following clinical laboratory criteria:
  • Absolute neutrophil count (ANC) ≥1,000/mm3 and platelet count≥75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days of enrollment.
  • Total bilirubin ≤1.5 the upper limit of the normal range (ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 ULN.
  • Calculated creatinine clearance ≥15 mL/min note: Patients with creatinine clearance of 15-50 mL/min will receive pomalidomide at a reduced dose (3 mg), which may subsequently be increased if well tolerated.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Female patients who:
  • Are postmenopausal for at least 24 months before the screening visit, OR
  • Are surgically sterile, OR
  • Who are of childbearing potential, and agree to practice two effective methods of contraception (1 highly effective method and 1 additional effective method) AT the same time, from the time of signing the informed consent through 90 days after the last dose of study treatment, OR agree to completely abstain from heterosexual intercourse, AND
  • Must also adhere to the guidelines of the pomalidomide pregnancy prevention program Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 milli International Units /mL (milli international units) within 10 to 14 days of initiation of Cycle 1 and again within 24 hours of starting Cycle 1. FCBP must also agree to ongoing pregnancy testing. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  • Male patients, even if surgically sterilized (i.e., status postvasectomy), who:
  • Agree to completely abstain from heterosexual intercourse, OR
  • Agree to practice effective barrier contraception (i.e., latex condom) during sexual contact with a FCBP, even if they have had a successful vasectomy, throughout the entire study treatment period and through 4 months after the last dose of study treatment AND
  • Must also adhere to the guidelines of the pomalidomide pregnancy prevention program.
  • Must be able to take concurrent aspirin 100mg daily (or enoxaparin 40 mg subcutaneously daily [or its equivalent] if allergic to aspirin) as prophylactic anticoagulation.
  • 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.
  • Patient is willing and able to adhere to the study visit schedule and other protocol requirements.

Who cannot join

  • Patients meeting any of the following exclusion criteria are not eligible to participate in the study:
  • Patient underwent an allogeneic transplantation
  • Female patients who are lactating or pregnant.
  • Major surgery within 14 days before enrollment.
  • Central nervous system involvement
  • Concomitant use of any other antineoplastic treatment with activity against MM (with the exception of ≤40 mg Dexamethasone per day or equivalent for no longer than 4 days).
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  • Infection requiring systemic antibiotic therapy or other serious infection within 14 days before enrollment
  • Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
  • Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
  • Anti-myeloma therapy as follows prior to screening bone marrow aspiration:
  • Targeted therapy, epigenetic therapy, within 14 days or at least 5 half-lives,whichever is less;
  • Monoclonal antibody treatment for multiple myeloma within 21 days;
  • Cytotoxic therapy within 14 days;
  • Proteasome inhibitor therapy within 14 days;
  • Immunomodulatory agent therapy within 7 days.
  • Radiotherapy within 14 days (with the exception of radiotherapy for spinal cord compression or for pain control that should be discussed and approved by the sponsor- investigator prior to study enrollment). However, if the radiation portal covered ≤5% of the bone marrow reserve, the subject is eligible irrespective of the end date of radiotherapy.
  • Systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of Cytochrome P450, family 3, subfamily A- clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole or strong Cytochrome P450, family 3, subfamily A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort within 14 days before enrollment in the study.
  • Ongoing or active systemic infection, active hepatitis B virus infection, active hepatitis C infection, or known human immunodeficiency virus (HIV) positive.
  • Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Psychiatric illness/social situation that would limit compliance with study requirements.
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
  • Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or known GI disease or planned gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment.
  • Diagnosed or treated for another malignancy within 2 years before 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.
  • Failure to have fully recovered (ie, Grade 1 toxicity) from the reversible effects of prior chemotherapy.
  • Patient has Grade 3 peripheral neuropathy 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.
  • Patients that have previously been treated with ixazomib or pomalidomide

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Israel7 sites
  • Emek Medical Center

    Afula, 18101

  • Rambam Medical Center

    Haifa

  • Hadassah Ein-Kerem Medical Center

    Jerusalem

  • Shearei Zedek Medical Center

    Jerusalem

  • Rabin Medical Center

    Petah Tikva

  • Sheba Tel Hashomer

    Ramat Gan

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

About this study

Official title: A Single-arm, Multisite, Prospective Study of Ixazomib-pomalidomide-dexamethasone as Second or Third-line Combination Treatment for Patients With Relapsed and Refractory Multiple Myeloma (RRMM) Previously Treated With Daratumumab, Lenalidomide and Bortezomib (IPoD-790 Study)

Adult patients with a confirmed diagnosis of symptomatic and relapsed and/or refractory MM, after receiving bortezomib, lenalidomide and daratumumab during first and second lines, will be eligible to be enrolled in this study.

During the first three treatment cycles, patients will be seen twice (Days 1 and 15 of the cycle). Starting from cycle 4 and on, patients will be assessed once per cycle (Day 1), until disease progression, for disease response and progression according to the International Myeloma Working Group (IMWG) criteria. After progression, all patients will be followed for survival; for this purpose, patients will be contacted every 12 weeks until death or termination of the study by the Sponsor.

Patients may continue to receive treatment for 24 months or until disease progression (PD) or unacceptable toxicity, the earlier of the three. Dose modifications may be made based on toxicities. Patients who complete study therapy will continue to receive treatment per standard of care.

Read the detailed description

This phase 2, open-label, single-arm, prospective, multicenter study will evaluate the safety, tolerability and efficacy of ixazomib-pomalidomide-dexamethasone (IPD) as a second or third-line combination treatment for patients with relapsed and/or refractory multiple myeloma (RRMM) who progressed after receiving bortezomib, lenalidomide and daratumumab during first and second lines. The patient population will consist of adult men and women who have a confirmed diagnosis of MM, who have received two prior lines of therapy, and who meet other outlined eligibility criteria. Following confirmation of eligibility, enrolled patients will be treated with pomalidomide plus dexamethasone as standard of care and will also receive ixazomib as a study drug.

The treatment regimen will involve administration of the following drugs:

Cycles 1-3: during each 21-day cycle:

  • ixazomib 3 mg on Days 1, 4, 8 and 11
  • pomalidomide 4 mg on Days 1 through 14
  • dexamethasone 20 mg on Days 1, 2, 8, 9, 15, 16

Cycle 4 and consequently: during each 28-day cycle:

  • ixazomib 4 mg on Days 1, 8 and 15
  • pomalidomide 4 mg on Days 1 through 21
  • dexamethasone 20 mg on Days 1, 2, 8, 9, 15, 16, 22 and 23 Patients may continue to receive treatment for 24 months or until disease progression (PD) or unacceptable toxicity, the earlier of the three. Dose modifications may be made based on toxicities. Patients who complete study therapy will continue to receive treatment per standard of care.

The main efficacy outcome- Progression Free Survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause. PFS will be determined by an investigator, based upon laboratory data, as defined by the IMWG criteria.

Secondary Endpoints:Objective response rate (ORR)is defined as the proportion of patients who achieve a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as defined using the IMWG criteria.

Overall Survival (OS) OS is defined as the time between the date of first dose and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive.

Time to Response (TTR) Time to Response is defined as the time from the first dose to the date of the first sCR, CR, VGPR, or PR. TTR will be evaluated for responders Duration of Response (DOR) Duration of Response is defined as the time between the date of first response to the date of the first objectively documented tumor progression as assessed by study steering committee according to modified IMWG criteria or death due to any cause prior to subsequent anti-cancer therapy.

Optional Exploratory Analysis RNA sequencing (by Massive Parallel (MARS)-seq method) of fresh or frozen cluster of differentiation 38+ (CD38+)/CD138+ plasma cells (normal and malignant) in the bone marrow of patients

Being tested
ixazomib-pomalidomide-dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

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

  • ixazomib-pomalidomide-dexamethasoneDrug

    Cycles 1-3: during each 21-day cycle:

    • ixazomib 3 mg on Days 1, 4, 8 and 11
    • pomalidomide 4 mg on Days 1 through 14
    • dexamethasone 20 mg on Days 1, 2, 8, 9, 15, 16

    Cycle 4 and consequently: during each 28-day cycle:

    • ixazomib 4 mg on Days 1, 8 and 15
    • pomalidomide 4 mg on Days 1 through 21
    • dexamethasone 20 mg on Days 1, 2, 8, 9, 15, 16, 22 and 23
Study groups in NCT04790474
Study groupRoleWhat they receive
ixazomib-pomalidomide-dexamethasone as second or third-line combination treatmentExperimentalProspective study of ixazomib-pomalidomide-dexamethasone as second or third-line combination treatment for patients with relapsed and refractory multiple myeloma (RRMM) previously treated with daratumumab, lenalidomide and bortezomib
Receives: Drug: ixazomib-pomalidomide-dexamethasone

What is being measured

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

  1. Progression-Free Survival-PFS

    The time from first dose to the date of the first documented tumor progression or death due to any cause

    Measured: Up to 2 years from last patient enrollment

Secondary outcomes (4)
  1. Objective Response Rate-ORR

    Proportion of patients who achieve a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as defined using the IMWG criteria.

    Measured: Up to 2 years from last patient enrollment

  2. Overall Survival-OS

    The time between the date of first dose and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive.

    Measured: Up to 2 years from last patient enrollment

  3. Time To Response-TTR

    The time from the first dose to the date of the first sCR, CR, VGPR, or PR. TTR will be evaluated for responders (BOR is either sCR, CR, VGPR, or PR) only.

    Measured: Up to 2 years from last patient enrollment

  4. Duration of Response-DOR-

    The time between the date of first response to the date of the first objectively documented tumor progression as assessed by study steering committee according to modified IMWG criteria or death due to any cause prior to subsequent anti-cancer therapy

    Measured: Up to 2 years from last patient enrollment

Timeline

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

  1. First posted10 Mar 2021
  2. Study start25 Mar 2021
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04790474
Sponsor's protocol ID
0776-19-TLV
Acronym
IPoD-790
Status last verified
Aug 2026
First submitted
7 Mar 2021
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shragai T, Lavi N, Vaxman I, Gatt ME, Chubar E, Ganzel C, Magen H, Luttwak E, Mittelman M, Trestman S, Lebel E, Saban R, Vainstein V, Zuckerman T, Horowitz N, Tzoran I, Horesh N, Lowenton-Spier N, Melamed N, Pereg I, Avivi I, Cohen YC. Ixazomib, pomalidomide and dexamethasone in triple-class exposed multiple myeloma patients - a phase II study. Haematologica. 2026 Sep 10. doi: 10.3324/haematol.2026.301067. Online ahead of print.

    PubMed 42719971

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ixazomib-pomalidomide-dexamethasone in people with Multiple Myeloma in Relapse and Refractory Multiple Myeloma, run by Tel-Aviv Sourasky Medical Center at 7 sites in Israel.

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 27 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. 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 Israel. 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?

This study is still under way. Results are not available in the source record yet.

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?

Progression-Free Survival-PFS (time frame: Up to 2 years from last patient enrollment). 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 NCT04790474, which also lists 1 linked publication.

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 11 Aug 2026.

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