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Relapsed/Refractory Multiple MyelomaPhase 2NCT03590652

Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma

A Phase 2 study testing Ixazomib, Pomalidomide and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by University of California, San Diego at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
Ixazomib, Pomalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
4 sitesUnited States
Study dates
17 Oct 2018to 2 Jul 2025
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

  • All participants must be registered into the mandatory POMALYST REMS program and be willing and able to comply with the requirements of the POMALYST REMS program.
  • Confirmed diagnosis of Multiple Myeloma having received 1 and 3 prior lines of treatment
  • Relapsed and/or refractory disease
  • Measurable disease
  • Life expectancy of more than 3 months
  • ECOG performance status of 0, 1, or 2
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  • No prior progression on pomalidomide
  • All pts must have received prior lenalidomide therapy and been determined to be relapsed and/or refractory.
  • Adequate hepatic function
  • Adequate renal function
  • Additional Laboratory Requirements
  • ANC ≥1.0 x 10^9/L, Hgb ≥8 g/dL (transfusion permitted)
  • Platelet count ≥75 x 10^9/L (≥ 50x10^9/L if bone marrow plasma cells are ≥50% of cellularity)
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity from the time of signing the informed consent for through 120 days after the last dose of study medication.
  • Women of childbearing potential have negative pregnancy test within 72 hours of initiating study drug dosing.
  • Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study therapy through 120 days after the last dose of study therapy.
  • All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS program.
  • Subjects must agree to take enteric-coated aspirin 81 mg orally daily, or if history of prior thrombotic disease, must be fully anticoagulated with warfarin (INR 2-3) or be treated with full-dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism (PE) at the investigator's discretion.

Who cannot join

  • Current or anticipated use of other investigational agents.
  • Prior daratumumab or ixazomib use
  • Patients who are refractory to pomalidom
  • Non-secretory or hyposecretory multiple myeloma defined as:
  • Plasma cell leukemia (>2.0 x 10 9/L circulating plasma cells by standard differential)
  • Waldenström's macroglobulinemia or IgM myeloma
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  • Known central nervous system involvement by multiple myeloma
  • Radiotherapy to multiple sites or immunotherapy within 2 weeks before enrollment (localized radiotherapy to a single site at least 1 week before start is permissible)
  • Participation in an investigational therapeutic study within 3 weeks or within 5 drug half-lives (t1/2) prior to first dose, whichever time is greater. Non-interventional trials (i.e. observational trials) are permitted at any time point
  • Female patients who are lactating or have a positive serum pregnancy test during the screening period.
  • Major surgery within 3 weeks prior to first dose
  • Myocardial infarction within 6 months prior to enrollment, NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
  • Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort.
  • Known or suspected HIV infection, known HIV seropositivity
  • Active hepatitis infection
  • 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.
  • Subjects with known or suspected light chain amyloidosis of any organ.
  • Known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, Daratumumab, or its excipients. or known sensitivity to mammalian-derived products.
  • Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal
  • Has known moderate or severe persistent asthma within the past 2 years per asthma guidelines
  • Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance of ixazomib or pomalidomide, including difficulty swallowing

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

  • University of California, Los Angeles

    Los Angeles, California, 90024

  • University of California, Davis

    Sacramento, California, 95817

  • University of California, San Francisco

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: Phase II Study of the Combination of Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma A University of California Hematologic Malignancies Consortium Protocol (UCHMC1809)

The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone.

Read the detailed description

The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone.

The drugs being used in this study are daratumumab ixazomib, pomalidomide, and dexamethasone. Ixazomib may stop the growth of cancer by interfering with proteasomes (the protein breakdown mechanism in the cells). Pomalidomide, and dexamethasone are standard drugs that can change and regulate the immune system and may stop cancer cells from growing. Both Ixazomib and Daratumumab are approved for use in Multiple Myeloma, but not in this combination.

Being tested
Ixazomib, Pomalidomide, Dexamethasone, Daratumumab-Hyaluronidase-Fihj@1,800 Mg-30,000 Unit/15 mL@SUBCUT@VIAL (ML)
Keywords
multiple myeloma, relapsed/refractory multiple myeloma, Daratumumab, Pomalidomide, Ixazomib, Dexamethasone, cancer, Phase 2, Darzalex, Pomalyst, Ninlaro, Decadron
Medical subject headings
Multiple Myeloma, Neoplasms

What participants receive

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

  • IxazomibDrug

    Also called Ninlaro

    4mg PO days 1,8,15 on 28-day cycle

  • PomalidomideDrug

    Also called Pomalyst

    4mg days PO 1-21/28 days

  • DexamethasoneDrug

    Also called Decadron

    40mg** PO weekly

    ** starting dose for age >75 may be 20mg

  • Daratumumab-Hyaluronidase-Fihj@1,800 Mg-30,000 Unit/15 mL@SUBCUT@VIAL (ML)Drug

    Also called Darzalex Faspro

    1800mg SQ weekly x 8 weeks, biweekly x 8 doses, then monthly

Study groups in NCT03590652
Study groupRoleWhat they receive
ixazomib, daratumumab, pomalidomide and dexamethasoneExperimentalDaratumumab will be administered at 16mg/kg IV weekly x 8 weeks, biweekly x 8 weeks, then monthly. Pomalidomide 4mg will be administered orally daily for days 1-21. Patients ≤ age 75 will receive a 40mg dose of dexamethasone, and those over the age of 75 may receive a 20mg dose of dexamethasone orally on days 1, 8, 15, and 22 (weekly). Ixazomib will be administered 4mg orally on days 1, 8 and 15.
Receives: Drug: Ixazomib; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Daratumumab-Hyaluronidase-Fihj@1,800 Mg-30,000 Unit/15 mL@SUBCUT@VIAL (ML)

What is being measured

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

  1. Overall Response Rate

    Anti-cancer response as defined by the International Uniform Response Criteria Consensus Recommendations

    Measured: 2 years

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Treatment-emergent Grade 2-5 adverse events (AEs) will be assessed using NCI CTCAE v4.03 toxicity criteria

    Measured: 2 years

Secondary outcomes (6)

  1. Clinical benefit rate

    CBR: minimal response +ORR

    Measured: 2 years

  2. Progression free survival (PFS)

    Progression-free survival (PFS) is defined as the duration of time from start of treatment until objective tumor progression or death

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  3. Time to progression

    Time to progression is defined as the duration of time from start of treatment until objective tumor progression.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  4. Overall survival (OS)

    Overall survival is defined as the duration of time from start of treatment to death

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  5. Minimal Residual Disease (MRD)

    Assessment on the presence of minimal residual disease for those in stringent complete response

    Measured: 1 year

  6. Quality of life (QOL) scores

    Cancer Therapy Satisfaction Questionnaire and EORTC QLQ-MY20

    Measured: 2 years

Timeline

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

  1. First posted18 Jul 2018
  2. Study start17 Oct 2018
  3. Primary completion2 Jul 2025
  4. Study completion2 Jul 2025

Why it stopped: The trial met its primary endpoint.

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03590652
Sponsor's protocol ID
180638
Status last verified
Oct 2025
First submitted
21 Jun 2018
Last updated
21 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixazomib, Pomalidomide and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by University of California, San Diego at 4 sites 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 19 inclusion and 22 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: stopped early, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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 stopped early (reason given: The trial met its primary endpoint.). Results are not available in the source record.

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?

Overall Response Rate (time frame: 2 years). 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?

On the ClinicalTrials.gov record for NCT03590652.

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 21 Oct 2025.

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