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Multiple MyelomaPhase 1NCT04405167

Tasquinimod for the Treatment of Relapsed or Refractory Myeloma

A Phase 1 study testing Tasquinimod and IRd chemotherapy in people with Multiple Myeloma, run by University of Pennsylvania at 1 site 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

This study is the first study of tasquinimod, an inhibitor of S100A9, in patients with multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Tasquinimod and IRd chemotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
10 Jul 2020to 1 Jul 2025
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

  • Signed informed consent
  • 18 years of age or older
  • Multiple myeloma (MM) diagnosed according to IMWG criteria
  • Measurable disease (this is defined differently in different arms)
  • Multiple myeloma relapsed or refractory to treatment (this is defined differently in different arms)
  • Meet certain clinical laboratory criteria
Show all 11Show fewer
  • ECOG performance status ≤2
  • Life expectancy of at least 3 months
  • For women of childbearing potential, a negative serum or urine pregnancy test prior to study treatment.
  • For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two methods of contraception one of which must be highly effective
  • For men: agreement to use a barrier method of contraception for 1 month before start of study treatment, during the treatment period and for 6 months after the last dose of study treatment.

Who cannot join

  • Failure to have fully recovered (i.e. ≤ Grade 1 toxicity) from the effects of prior chemotherapy (except for alopecia)
  • Active graft versus host disease
  • Treatment with any of the following:
  • Cytotoxic chemotherapy within 3 weeks prior to the initiation of study treatment
  • Proteasome inhibitors, Imids, or monoclonal antibodies within 2 weeks prior to the initiation of study treatment
  • Experimental therapy within 4 weeks or 5 half-lives, whichever is shorter
Show all 33Show fewer
  • Systemic corticosteroids >=10 mg prednisone or equivalent within 7 days prior to the initiation of study treatment
  • Radiotherapy within 7 days prior to initiating study treatment
  • Plasmapheresis within 4 weeks prior to the initiation of study treatment
  • Tasquinimod at any time
  • Known central nervous system involvement by myeloma
  • Diagnosis of smoldering multiple myeloma
  • Diagnosis of POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Active plasma cell leukemia
  • Symptomatic primary (AL) amyloidosis
  • Diagnosis of myelodysplastic syndrome or myeloproliferative syndrome
  • Active other malignancy
  • Major surgery within 4 weeks prior to initiating study treatment
  • Evidence of severe or currently uncontrolled cardiovascular condition
  • Ongoing or active systemic infection that requires systemic antibiotic or parenteral anti-infective therapy
  • Active tuberculosis, active hepatitis A, B or C virus infection, or known human immunodeficiency virus (HIV) positive
  • History of pancreatitis
  • History of malabsorption or other condition that would interfere with absorption of study drugs
  • Systemic treatment within 14 days prior to the initiation of study treatment with moderate or strong inhibitor or moderate or strong inducer of cytochrome P-3A4 (CYP3A4)
  • Need for ongoing therapy drug substances of narrow therapeutic range that are metabolized mainly by CYP3A4 (alfentanil, fentanyl, quinidine, astemizole, terfenadine, sirolimus, tacrolimus, cyclosporine, cisapride, ergotamine)
  • Need for ongoing therapy with drug substances of narrow therapeutic range metabolized mainly by CYP1A2 (duloxetine, alosetron, theophylline, tizanidine, ondansetron)
  • Ongoing treatment with warfarin, unless the INR is <=3.0.
  • For subjects enrolled on the IRd combination arms, prior dose-limiting toxicity with lenalidomide or ixazomib or absolute contraindication to concomitant thrombosis prophylaxis
  • Peripheral neuropathy grade ≥2 (NCI-CTCAE)
  • Known hypersensitivity to tasquinimod or any excipients in the study treatments
  • Pregnant or nursing (lactating) women
  • Any other condition that would, in the Investigator's judgment, contraindicate subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures
  • Prior inclusion in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase 1 Study of Tasquinimod Alone and in Combination With Standard Therapy for Relapsed or Refractory Myeloma

This study is the first study of tasquinimod, an inhibitor of S100A9, in patients with multiple myeloma.

Read the detailed description

Tasquinimod has previously been studied as an anti-cancer agent in patients with other cancers, including a phase 3 randomized trial in patients with metastatic prostate cancer that showed an improvement in radiographic progression-free survival. The side effect profile of tasquinimod is well-characterized based on this previous experience. This trial will establish a maximum tolerated dose and optimal schedule for administration of tasquinimod in patients with multiple myeloma and then investigate the maximum tolerated dose of tasquinimod in combination with a standard myeloma regimen of ixazomib, lenalidomide, and dexamethasone (IRd). For both single agent tasquinimod and the combination of tasquinimod with IRd, exploratory expansion cohorts will be enrolled to preliminarily characterize the antimyeloma activity of each regimen.

Being tested
Tasquinimod, IRd chemotherapy
Medical subject headings
Multiple Myeloma

What participants receive

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

  • TasquinimodDrug

    Tasquinimod will be supplied as oral capsules.

  • IRd chemotherapyDrug

    Also called Ixazomib, Lenalidomide, Dexamethasone

    IRd chemotherapy with ixazomib, lenalidomide, and dexamethasone

Study groups in NCT04405167
Study groupRoleWhat they receive
A1: Tasquinimod single agent dose escalationExperimentalThere are up to 5 planned dose levels, with 3 de-escalation dose levels available in case dose level 1 is determined to exceed the MTD. This arm will enroll 15-30 subjects if all dose levels are explored.
Receives: Drug: Tasquinimod
A2: Tasquinimod single agent expansionExperimentalAdditional subjects will enroll in arm A2 at the MTD and optimal schedule, so that 12 subjects total who are evaluable for response will have received the MTD/optimal schedule of single agent tasquinimod. Enrollment in arm A2 will not begin until enrollment in arm A1 has been completed and a single agent MTD/optimal schedule has been established.
Receives: Drug: Tasquinimod
B1: Tasquinimod+IRd dose escalationExperimentalDose levels will be defined according to the same tasquinimod doses as in the single agent (Arm A1) dose escalation. Enrollment in arm B1 will not begin until enrollment in arm A1 has been completed and an MTD/optimal schedule has been established for single agent tasquinimod. Initial subjects in arm B1 will be enrolled at the lower of dose level 1 or one dose level below the single agent MTD . If this initial dose level is determined to exceed the combination MTD, further subjects will be enrolled at one dose level lower. Enrollment is not planned in arm B1 at doses higher than the single agent MTD. There are 9-12 planned subjects if all dose levels are explored.
Receives: Drug: Tasquinimod; Drug: IRd chemotherapy
B2: Tasquinimod+IRd expansionExperimentalAdditional subjects will enroll in arm B2 at the MTD and optimal schedule, so that 12 subjects total who are both evaluable for response and previously refractory to their most recent Imid/PI combination will have received the MTD/optimal schedule of tasquinimod in combination with ixazomib, lenalidomide, and dexamethasone. To facilitate rapid enrollment and gain more experience with the combination therapy, up to 12 additional subjects with triple-class refractory myeloma (who are not previously refractory to their most recent Imid/PI combination) may be enrolled in cohort B2. Enrollment in arm B2 will not begin until enrollment in arm B1 has been completed and a combination MTD/optimal schedule has been established.
Receives: Drug: Tasquinimod; Drug: IRd chemotherapy

What is being measured

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

  1. Optimal Dose

    Maximum tolerated dose of single agent tasquinimod (mg).

    Measured: approximately 3 years

Secondary outcomes (4)

  1. Preliminary Single-Agent Toxicity Profile

    Percentage of subjects experiencing treatment-emergent grade 3/4 adverse events during therapy with single-agent tasquinimod (using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 5)

    Measured: approximately 3 years

  2. Preliminary Combination Therapy Toxicity Profile

    Percentage of subjects experiencing treatment-emergent grade 3/4 adverse events during therapy with tasquinimod, ixazomib, lenalidomide, and dexamethasone (using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 5)

    Measured: approximately 3 years

  3. Preliminary Single-Agent Response

    Percentage of subjects achieving a partial response or better with single-agent tasquinimod (using the response criteria of the International Myeloma Working Group)

    Measured: approximately 3 years

  4. Preliminary Assessment of Clinical Response Combination Therapy

    Percentage of subjects achieving a partial response or better with tasquinimod, ixazomib, lenalidomide, and dexamethasone (using the response criteria of the International Myeloma Working Group)

    Measured: approximately 3 years

Timeline

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

  1. First posted28 May 2020
  2. Study start10 Jul 2020
  3. Primary completion19 May 2025
  4. Study completion1 Jul 2025

Why it stopped: Slow accrual at the time when sufficient participants were already enrolled to answer the scientific question posed by the study.

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Open label phase 1 study with pilot expansion cohorts at the maximum tolerated dose
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04405167
Sponsor's protocol ID
842603, UPCC 45419
Other IDs
UPCC 45419
Status last verified
Oct 2025
First submitted
11 Mar 2020
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fan R, Satilmis H, Vandewalle N, Verheye E, Vlummens P, Maes A, Muylaert C, De Bruyne E, Menu E, Evans H, Chantry A, De Beule N, Hose D, Torngren M, Eriksson H, Vanderkerken K, Maes K, Breckpot K, De Veirman K. Tasquinimod suppresses tumor cell growth and bone resorption by targeting immunosuppressive myeloid cells and inhibiting c-MYC expression in multiple myeloma. J Immunother Cancer. 2023 Jan;11(1):e005319. doi: 10.1136/jitc-2022-005319.

    PubMed 36650020

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tasquinimod and IRd chemotherapy in people with Multiple Myeloma, run by University of Pennsylvania 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 11 inclusion and 33 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 7 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 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 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 was stopped early (reason given: Slow accrual at the time when sufficient participants were already enrolled to answer the scientific question posed by the study.). 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?

Optimal Dose (time frame: approximately 3 years). 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 NCT04405167, 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 7 Oct 2025.

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