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Multiple MyelomaPhase 1/2COMMANDERNCT05434689

COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide

A Phase 1/2 study testing Iberdomide, Daratumumab and Dexamethasone in people with Multiple Myeloma, run by University of Alabama at Birmingham at 4 sites in United States.

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

Similar to the paradigm established in other hematologic malignancies that are considered curable, the achievement of MRD(-) status is necessary for long term disease control in MM. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Iberdomide, Daratumumab and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
4 sitesUnited States
Study dates
18 Jan 2023to Aug 2028
Phase
Phase 1/2
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >18 years with no upper age limit
  • Confirmation of newly diagnosed multiple myeloma (MM) with 1-2 prior regimens utilized in induction that included an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI) combined or in different regimens
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Prior AHCT 100-180 days prior to initiation of protocol-directed therapy
  • MRD ≥ 10^-5 by clonoSEQ® NGS platform, determined 60-120 days after AHCT as part of the usual care.
  • No prior disease progression (either before or since AHCT)
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  • Overall response (i.e post-AHCT compared to historical baseline prior to initiation of any therapy for MM) ≥ PR.
  • Measurable disease at the time of the initial diagnosis (i.e. prior to starting any therapy for MM) meeting at least one of the following criteria:
  • Serum monoclonal (M) protein ≥1.0 g/dl
  • 200 mg of M protein/24h in the urine
  • Difference between involved and uninvolved free light chain ≥10 mg/dL and abnormal kappa to lambda ratio.
  • Adequate hepatic function evidenced by AST and ALT ≤ 3 x ULN and bilirubin ≤ 1.5 ULN.
  • Adequate bone marrow function evidenced by platelets ≥ 75,000 /mm3 (without transfusion of platelets in the prior 7 days) and absolute neutrophil count ≥ 1,000/mm3.
  • Creatinine clearance (CrCl) ≥ 40 mL/minute within 28 days prior to start of therapy either measured or calculated using standard Cockcroft and Gault formula (available in https://www.kidney.org/professionals/KDOQI/gfr_calculatorCoc ).
  • Females of childbearing potential (FCBP) must have two negative pregnancy tests as verified by the investigator and agree to ongoing pregnancy testing and to practice contraception during treatment. Male subjects must agree to practice contraception and refrain from donating sperm during treatment.
  • In line with the higher incidence of MM in Blacks, and to address the historical underrepresentation of ethnical minorities in MM trials, at least 25% of the enrolled patients will be of ethnical minorities.
  • Written informed consent in accordance with federal, local, and institutional guidelines.

Who cannot join

  • Diagnosis of amyloidosis, POEMS, Waldenstrom's macroglobulinemia, plasma cell leukemia or smoldering multiple myeloma (i.e. never evolved to active myeloma).
  • Major surgery or radiotherapy within 28 days of starting protocol-directed treatment.
  • Acute active infection requiring treatment within 14 days of starting protocol-directed treatment.
  • Current or prior involvement of central nervous system by multiple myeloma.
  • MM refractory to prior CD38 monoclonal antibody therapy and/or to carfilzomib (prior exposure allowed). Refractoriness here is defined as not achieving at least a PR in a regimen containing the agent or disease progression < 60 days from last dose of the agent.
  • Pregnant or lactating females.
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  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
  • Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
  • Unstable angina or myocardial infarction within 4 months prior to starting protocol-directed treatment, NYHA Class II, III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker.
  • A prolongation of QT interval on screening electrocardiogram (ECG) as defined by corrected QT interval (QTc) > 480 ms using Fridericia's QT correction formula.
  • Cerebrovascular disease manifested as prior stroke at any time or TIA in the 12 months prior to initiation of therapy.
  • Uncontrolled hypertension (per investigator assessment, despite optimal medical management)
  • Diagnosis of interstitial lung disease
  • Nonhematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or localized thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas.
  • Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 28 days prior to starting protocol-directed treatment.
  • For regimen B - Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib).
  • Contra indication or intolerance to required supportive care medications (Aspirin and Acyclovir)
  • Concomitant use of strong inhibitors or inducers of CYP3A4, P-gp, or BCRP, or BCRP substrate with a narrow therapeutic index, for at least 14 days or 5 half-lives (whichever is shorter). (consult https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers )
  • Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent Diagnosis of amyloidosis, POEMS, Waldenstrom's macroglobulinemia.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Ohio State University Medical College

    Columbus, Ohio, 43210

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Oregon Health and Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Phase Ib/II Trial Of Iberdomide-Combinations In Patients With Positive Minimal Residual Disease (>10-5) After Autologous Hematopoietic Cell Transplantation In The Upfront Management Of Patients With Multiple Myeloma

Similar to the paradigm established in other hematologic malignancies that are considered curable, the achievement of MRD(-) status is necessary for long term disease control in MM. The fact that the majority of patients remain MRD (+) after induction therapy and AHCT points to the opportunity to deploy novel agents with complementary mechanism of action and favorable toxicity profile to reach and maintain MRD (-) status.

Given its favorable toxicity profile, the convenience of oral administration, and compelling single agent activity even in heavily pretreated MM, iberdomide is likely amenable to long term therapy in patients with high-risk of relapse/progression identified by the persistence of MRD(+). The investigators intend to develop combination(s) of iberdomide with other agents with complementary mechanism of action in the consolidation setting post AHCT in order to achieve and sustain MRD (-).

Being tested
Iberdomide, Daratumumab, Dexamethasone, Carfilzomib
Medical subject headings
Multiple Myeloma

What participants receive

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

  • IberdomideDrug

    Iberdomide (Iber, CC-220) is a novel cereblon E3 ligase modulator (CELMoD) in development for treatment of multiple myeloma and other conditions.

  • DaratumumabDrug

    Anti-CD 38 monoclonal antibody established in the treatment of multiple myeloma

  • DexamethasoneDrug

    Corticosteroid active against multiple myeloma in combination with other agents

  • CarfilzomibDrug

    Second generation proteasome inhibitor with activity in multiple myeloma

Study groups in NCT05434689
Study groupRoleWhat they receive
Iberdomide, Daratumumab and Dexamethasone (Regimen A)ExperimentalIberdomide dosed according to cohort assignment days 1-21. Dexamethasone 40 mg oral or intravenously (20 mg for participants 70 or older) on days 1,8,15 and 22 Darartumumab and hyalurnonidase-fihj 1,800mg/30,000 units subcutaneously on days 1,8,15,22 (cycles 1,2) or on days 1,15 (cycles 3-6)
Receives: Drug: Iberdomide; Drug: Daratumumab; Drug: Dexamethasone
Iberdomide, Carfilzomib, Daratumumab and Dexamethasone (Regimen B)ExperimentalIberdomide dosed according to cohort assignment days 1-21. Dexamethasone 40 mg oral or intravenously (20 mg for participants 70 or older) on days 1,8,15 and 22 Darartumumab and hyalurnonidase-fihj 1,800mg/30,000 units subcutaneously on days 1,8,15,22 (cycles 1,2) or on days 1,15 (cycles 3-6) Carfilzomib dosed intravenously dosed according to cohort assignment on days 1, 8, 15 (Consistent with standard practice, the very first dose of carfilzomib (cycle 1 day 1) must be 20 mg/m^2).
Receives: Drug: Iberdomide; Drug: Daratumumab; Drug: Dexamethasone; Drug: Carfilzomib

What is being measured

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

  1. Dose limiting toxicity

    Proportion of patients in each regimen who develop dose limiting toxicity

    Measured: One year

  2. MRD conversion ( to < 10-5 MM-associated molecules)

    Rate MRD conversion ( to <10-5 MM-associated molecules) at completion of consolidation therapy. Patients who are not assessed for MRD at the completion of consolidation (due to any reason, including death, withdrawal from study, loss to follow-up, missed assessment, etc) will be considered as not having achieved MRD conversion.

    Measured: Four 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 Jun 2022
  2. Study start18 Jan 2023
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05434689
Sponsor's protocol ID
IRB-300008590
Other IDs
Amgen, Inc, BMS
Acronym
COMMANDER
Status last verified
May 2026
First submitted
10 Jun 2022
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Iberdomide, Daratumumab and Dexamethasone in people with Multiple Myeloma, run by University of Alabama at Birmingham 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 17 inclusion and 19 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 1 Jun 2026. 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 combined 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.

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?

Dose limiting toxicity (time frame: One year). 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 NCT05434689.

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 1 Jun 2026.

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