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Multiple MyelomaPhase 2IBEXNCT06107738

Iberdomide and Daratumumab as Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma

A Phase 2 study testing Iberdomide and Daratumumab/rHuPH20 Co-formulation in people with Multiple Myeloma, run by Barbara Ann Karmanos Cancer Institute at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this phase 2 clinical trial is to learn if patients with Multiple Myeloma who are minimal residual disease positive after initial therapy (including an autologous stem cell transplant [ASCT]) will benefit from maintenance therapy with Iberdomide and subcutaneous (SC) Daratumumab. 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?
Iberdomide and Daratumumab/rHuPH20 Co-formulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
21 Dec 2023to 31 Dec 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

  • Multiple Myeloma patients who have received prior DARA-containing induction therapy and have attained at least a partial response.
  • Patients who have completed Autologous Stem Cell Transplant (ASCT) 90-150 days prior to registration, without any post-ASCT therapy and without post-ASCT disease progression (according to IMWG criteria)
  • Patients who are Minimal Residual Disease positive (MRD (+)) as measured by the ClonoSEQ assay using a sensitivity of 10-5, measured 90-150 days following ASCT.
  • Prior DARA-containing induction therapy (at least 3 cycles), attaining at least a partial response.
  • Completed ASCT within 90-150 days prior to registration, without any post-ASCT therapy and without evidence of post-ASCT disease progression (according to IMWG criteria)
  • MRD (+) at the time of study enrollment using the clonoSEQ NGS (next-generation sequencing) assay. Patients with an M-spike of ≥ 0.5 g/dL and/or an abnormal free light chain ratio (with an involved serum free light chain of ≥ 10 mg/dL) at enrollment are considered MRD (+) and do not require baseline MRD testing if they have previously had this testing done with successful clonality assessment.
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  • ECOG (Eastern Cooperative Oncology Group) Performance Status </= 2
  • Adequate bone marrow function as evidenced by platelets >/= 75,000/mm3, hemoglobin >/= 8 g/dL, and ANC (absolute neutrophil count) >/= 1,000/mm3 within 28 days prior to registration. NOTE: transfusion to achieve the hemoglobin threshold IS permissible.
  • Adequate hepatic function defined by the following within 28 days prior to registration: total bilirubin </=1.5 x IULN (institutional upper limit of the norm, except in case of Gilbert's syndrome) AND AST (aspartate aminotransferase and ALT (aspartate transaminase) </=3.0 x IULN
  • Adequate renal function, as defined by creatinine clearance (CrCl) >/= 30 mL/min., as measured by a 24-hour urine collection or estimated by the Cockcroft and Gault formula within 28 days prior to registration.
  • All ASCT-related toxicities must have recovered to </=Grade 1 (except for alopecia, fatigue and amenorrhea) prior to registration
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU (milli-International unit)/mL within 10-14 days prior to registration. FCBP must agree to have a second pregnancy test within 24 hours prior to starting Cycle 1. Further, FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 7 days before starting IBER, during therapy, during dose interruptions and continuing for 28 days following discontinuation of Iberdomide and for 90 days following the discontinuation of daratumumab. FCBP must also agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 28 days after the last dose of iberdomide and for 90 days after the last dose of daratumumab. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. Females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed.
  • Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy, during the study treatment and for 90 days after the last dose of study treatment. They must also agree to not donate sperm during the study and for 90 days after either the last dose of iberdomide or the last dose of daratumumab.
  • Must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • Age 18 yrs. old or greater

Who cannot join

  • Active HIV, or HCV (defined as detectable viremia for any of these conditions).
  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen[HBsAg]). Patients with resolved infection (i.e., patients 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 PCR (polymerase chain reaction) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded.
  • EXCEPTION: Patients 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
  • Unable to assess MRD status at entry or is MRD(-) at 10-5 threshold at entry
  • Heart attack or stroke within 90 days of study enrollment
  • Unable to tolerate required anti-thrombotic or anti-viral prophylaxis
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  • Major surgery within 28 days of enrollment
  • Medical, neurologic, or psychiatric condition which renders patient unable to safely comply with study therapy and schedule requirements (including, but not limited to, unstable angina, New York Heart Association Class III-IV congestive heart failure, or uncontrolled cardiac arrhythmia)
  • Intolerance of prior DARA therapy (requiring discontinuation of DARA previously due to toxicity)
  • A history of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease before the date of enrollment. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years.
  • Be exhibiting clinical signs of meningeal or central nervous system involvement due to multiple myeloma.
  • Have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal.
  • Have known moderate or severe persistent asthma within the past 2 years (see Section 9.2.4), or current uncontrolled asthma of any classification. Note that patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study, provided that FEV1 is ≥50% of predicted normal.
  • Note: pursuant to exclusion criteria (k) and (l), FEV1 testing is required for patients with suspected COPD or asthma. Patients with FEV1 <50% of predicted normal (or for patients ≥65 years of age, old FEV1 <50% or diffusing capacity of the lung [DLCO] <50%) on screening assessment must be excluded.
  • Have any of the following:
  • Myocardial infarction within 6 months of enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV),
  • Uncontrolled cardiac arrhythmia
  • Have known allergies, hypersensitivity, or intolerance to boron or mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to the IB) or known sensitivity to lenalidomide, thalidomide, or pomalidomide.
  • Be pregnant, or breast-feeding, or planning to become pregnant or breast-feed while enrolled in this study or within 90 days after the last dose of study treatment(s). Or, if male, planning to father a child while enrolled in this study or within 90 days after the last dose of study treatment(s).
  • Prolongation of QT interval on screening ECG as defined by a QTc interval > 470 msec using Fridericia's QT correction formula.
  • Use of strong inhibitors or inducers of CYP3A4, P-gp, or BCRP for at least 14 days or 5 half-lives (whichever is shorter) prior to initiating protocol therapy.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jeffrey Zonder contact

3135768732

zonderj@karmanos.org

United States2 sites, 2 recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Christiane Houde, 3135768673, Houdec@karmanos.org

    Jeffrey Zonder, M.D.

    Recruiting

  • KCI at McLaren Greater Lansing

    Lansing, Michigan, 48910

    Craig Cole, M.D., 734-664-2488, colec@karmanos.org

    Craig Cole, M.D.

    Recruiting

Other trials in United States

About this study

Official title: IBEX: Phase 2 Trial of Iberdomide + SQ Daratumumab as Post-Autologous Stem Cell Transplant Maintenance Therapy in Multiple Myeloma

The goal of this phase 2 clinical trial is to learn if patients with Multiple Myeloma who are minimal residual disease positive after initial therapy (including an autologous stem cell transplant [ASCT]) will benefit from maintenance therapy with Iberdomide and subcutaneous (SC) Daratumumab. The main questions it aims to answer are:

  • Assess if giving Iberdomide and the SC Daratumumab in the maintenance setting is an effective treatment and warrants further investigation in patients with residual disease
  • Is giving Iberdomide and SC Daratumumab maintenance post ASCT a safe option
Read more

Participants will:

  • provide informed consent and complete screening assessments for eligibility within 28 days of starting treatment
  • Screening assessments include specific laboratory tests, a medical history assessment and a physical examination (including temperature, pulse, blood pressure, respirations, height and weight), an assessment of your heart function, a breathing test, cancer imaging, a bone marrow biopsy, minimal residual disease testing (MRD) and a questionnaire
  • If eligible, patients will start treatment with Iberdomide (1.0 mg on day 1-21 of each 28 day cycle, with an increase to 1.3 mg on Cycle 4 if the 1.0 mg dose was tolerated, to a maximum of 26 cycles or progressive disease, whichever is first) and SC Daratumumab (1800 mg SC on days 1, 8, 15 and 22 of cycle 1 and 2, then 1800 mg SC on Day 1 and 15 of cycle 3-6 and 1800 mg SC on Day 1 for cycles 7-26 to a maximum of 26 cycles or progressive disease, whichever is first)
  • while receiving treatment on study, physical exams (including temperature, pulse, blood pressure, respirations, height and weight), toxicity assessments, laboratory assessments and questionnaires will be done at various times over the course of the 26 cycles
  • an MRD assessment is required at 6, 12 and 24 months after starting treatment
  • End of treatment will occur once 26 cycles are completed, or cancer has progressed whichever comes first. At that time, specific laboratory tests, a physical examination (including temperature, pulse, blood pressure, respirations, height and weight), cancer imaging, a bone marrow biopsy and minimal residual disease testing (MRD) will occur.
Being tested
Iberdomide, Daratumumab/rHuPH20 Co-formulation
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

    Also called CC220

    Iberdomide 1.0mg daily for days 1-21 of a 28-day cycle, an increase to 1.3 mg daily on Day 1-21 of a 28-day cycle is allowed at cycle 4 or higher if the 1.0 mg dose was well tolerated.

  • Daratumumab/rHuPH20 Co-formulationDrug

    Also called Darzalex FASPRO, Daratumumab and Hyaluronidase-fihj

    Daratumumab/rHuPH20 will be dosed as follows:

    • Daratumumab/rHuPH20 1800 mg SC days 1, 8, 15, 22 (28-day cycle; cycles 1-2)
    • Daratumumab/rHuPH20 1800 mg SC days 1, 15 (28-day cycle; cycles 3-6)
    • Daratumumab/rHuPH20 1800 mg SC day 1 (28-day cycle; cycles 7-26)
Study groups in NCT06107738
Study groupRoleWhat they receive
Iberdomide and DaratumumabExperimentalNot described
Receives: Drug: Iberdomide; Drug: Daratumumab/rHuPH20 Co-formulation

What is being measured

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

  1. Rate of MRD (-) at 12 months

    Summarized by a binomial response rate and its associated 2-sided 90% confidence interval (CI) using Pearson-Klopper method.

    Measured: 12 months

Secondary outcomes (9)

  1. Rate of Sustained MRD (-)

    The rate at which IMWG (International Myeloma Working Group) response category improves by at least one grade during maintenance and the rate of treatment interruptions and dosage adjustments during maintenance will be summarized by a binomial response rate and 2-sided 95% CI using Pearson-Klopper method. Two or more consecutive negative measurements during therapy which are at least 6 months apart.

    Measured: 24 months

  2. Progression-Free Survival

    Duration from the start date of treatment until the date of progression (as defined by IMWG criteria) or death from any cause.

    Measured: 12 months

  3. Progression Free Survival

    Duration from the start date of treatment until the date of progression (as defined by IMWG criteria) or death from any cause.

    Measured: 24 months

  4. Overall Survival

    Duration from the start date of treatment until the date of death from any cause

    Measured: 12 months

  5. Overall Survival

    Duration from the start date of treatment until the date of death from any cause

    Measured: 24 months

  6. Rate on Improvement in IMWG response category

    Rate at which IMWG response category improves by at least 1 grade

    Measured: 24 months

  7. Frequency of treatment interruptions and dosage adjustments during maintenance

    Frequency of treatment interruptions and dosage adjustments during maintenance.

    Measured: 24 months

  8. Patient reported Quality of Life (QoL) per EORTC QLQ-C30

    The 30 question European Organization for Research and Treatment, Quality of Life Questionnaire for cancer patients (EORTC QLQ-C30) is a 30-item subject self-reported questionnaire composed of both multi-item and single scales. The EORTC QLQ-C30 questionnaire is scored using a four-point Likert scale. The scores are then transformed to a scale of 0 to 100, where higher scores indicate better quality of life. The questionnaire includes five functions, nine symptoms, and a global health status.

    Measured: At baseline and day 1 of each treatment cycle until end of treatment

  9. Patient reported Quality of Life (QoL) per EQ-5D-5L

    The European Organization for Research and Treatment EuroQol (EORTC EQ-5D-5L) questionnaire is a patient reported health-related quality of life questionnaire that consists of two parts: The first part is the EQ-5D descriptive system that measures the respondent's health status in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Items are rated 1=No problem, 2=Slight Problem, 3=Moderate Problem, 4=Severe Problem and 5=Extreme Problem or inability. Part 2 is the EQ visual analogue scale (EQ VAS) records the respondent's overall current health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

    Measured: At baseline and day 1 of each treatment cycle until end of treatment

Timeline

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

  1. First posted30 Oct 2023
  2. Study start21 Dec 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06107738
Sponsor's protocol ID
2022-082
Other IDs
ISR IMO48-025, 54767414MMY2092, MMRC-095
Acronym
IBEX
Status last verified
Jun 2026
First submitted
12 Oct 2023
Last updated
26 Jun 2026
Results posted
No
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 Iberdomide and Daratumumab/rHuPH20 Co-formulation in people with Multiple Myeloma, run by Barbara Ann Karmanos Cancer Institute at 2 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 15 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 26 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 2 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?

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?

Contact Jeffrey Zonder (3135768732, zonderj@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of MRD (-) at 12 months (time frame: 12 months). 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 NCT06107738.

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 26 Jun 2026.

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