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Recurrent Multiple MyelomaPhase 1/2NCT06232044

Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1/2 study testing Iberdomide, Belantamab Mafodotin and Dexamethasone in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by Alliance for Clinical Trials in Oncology at 43 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This phase I/II trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Iberdomide, Belantamab Mafodotin and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
43 sitesUnited States
Study dates
23 Apr 2025to 1 Aug 2030
Phase
Phase 1/2
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
  • Documentation of disease: Diagnosis of multiple myeloma and have relapsed or refractory disease according to the IMWG criteria where:
  • Progression of myeloma is defined by IMWG criteria as recurrence of disease after prior response, indicated as any of the following:
  • ≥ 25% increase in M-protein (must be at least 0.5g/dl above nadir from last treatment regimen).
  • 25% difference between involved and uninvolved serum free light chains from its nadir or
  • The development of new plasmacytomas or hypercalcemia.
  • Refractory myeloma as defined by IMWG criteria as disease which become non-responsive or progresses on therapy or within 60 days of last treatment in patients who had achieved a minimal response or better on prior therapy.
  • Measurable disease defined by IMWG criteria as:
  • Serum M-protein ≥ 0.5 g/dL.
  • Urine monoclonal protein ≥ 200 mg/24h.
  • Serum free light chains (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) and serum free light chain ratio is abnormal.
  • Two or more prior lines of therapies, triple-class exposed (exposed /refractory to an immunodulatory derivative (IMiD) and/or proteasome inhibitors (PI) and/or to daratumumab or other anti-CD38 monoclonal antibody).
  • No prior exposure to iberdomide or belamaf.
  • No prior BCMA-directed therapy.
  • No prior treatment with a monoclonal antibody within 2 weeks of registration.
  • No history of severe allergic reaction (including erythema nodosum) to lenalidomide, pomalidoimide or other prior IMiD therapy.
  • No prior allogeneic stem cell transplant. NOTE: Participants who have undergone syngeneic transplant will be allowed only if no history of or no currently active GvHD.
  • Participant must not have received a live or live-attenuated vaccine within 30 days prior to registration.
  • No plasmapheresis within 7 days prior to registration.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3.
  • Platelet count ≥ 75,000/mm^3 (or ≥ 50,000/mm^3 in Phase II if bone marrow (BM) plasma cells > 50%).
  • Calculated (Calc.) creatinine clearance ≥ 30 mL/min using Cockcroft-Gault equation.
  • Spot urine (albumin/creatinine ratios) < 500 mg/g (56 mg/mmol) OR urine dipstick ≥ 1+ if confirmed.
  • Total bilirubin ≤ 2 mg/dL.
  • Aspartate aminotransferase (AST)/alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN).
  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown. FCBP (female of childbearing potential) is a female who: 1) has achieved menarche (first menstrual cycle) at some point, 2) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months). Women of childbearing potential (WOCBP):
  • Must use a contraceptive method that is highly effective (with a failure rate of < 1% per year), preferably with low user dependency during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
  • The effects of iberdomide on the developing human fetus are unknown. Immunodulatory derivative (IMiD) agents as well as other therapeutic agents used in this trial are known to be teratogenic. Females of child-bearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to, and again within 24 hours of starting iberdomide, and 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 28 days before she starts taking iberdomide. Examples of highly effective methods are intrauterine device, hormonal contraceptives, tubal ligation, or partner's vasectomy. Examples of barrier method are male condom, diaphragm, or cervical cap. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risk of fetal exposure.
  • Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. FCBP must use adequate contraception for at least 4 months after discontinuation from study. Because of the potential for serious adverse reactions in a breastfed child, women are advised not to breastfeed during treatment and for at least 3 months after the last dose.
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy. Nonchildbearing potential is defined as follows (by other than medical reasons):
  • ≥ 45 years of age and has not had menses for > 1 year
  • Patients who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
  • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
  • Male patients must agree to use an adequate method of contraception for the duration of the study and for 6 months afterwards.
  • Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies: Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:
  • Refrain from donating sperm PLUS, either:
  • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
  • Must agree to use contraception/barrier as detailed below:
  • Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of < 1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).
  • Archival tissue must be available for submission for the mandatory correlative studies.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression.
  • No patients with uncontrolled human immunodeficiency virus (HIV), hepatitis C and B. Testing for HIV and hepatitis C and B are not required prior to registration.
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • No positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to registration unless the participant can meet the following criteria:
  • RNA test negative.
  • Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C virus (HCV) RNA test after a washout period of at least 4 weeks.
  • Patients with hepatitis B will be excluded unless the following criteria can be met.
  • Serology: Hepatitis B core antibody positive (HbcAb)+, hepatitis B surface antigen (HbsAg)-.
  • Screening: Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) undetectable.
  • During study treatment: Monitoring per protocol.
  • During study treatment: Antiviral treatment instituted if HBV DNA becomes detectable.
  • Serology: HBsAg+ at screen or within 3 months prior to registration.
  • Screening: HBV DNA undetectable.
  • Screening: Highly effective antiviral treatment started at least 4 weeks prior to first registration.
  • Screening: Baseline imaging per protocol.
  • Screening: Participants with cirrhosis are excluded.
  • During study treatment: Antiviral treatment maintained throughout study treatment.
  • During study treatment: Monitoring and management per protocol. ** Note: Presence of isolated hepatitis (Hep) B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.
  • No patients with unacceptable cardiac risk factors defined by any of the following criteria:
  • Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.
  • History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of Screening.
  • Class III or IV heart failure as defined by the New York Heart Association functional classification system [Error! Reference source not found., 1994].
  • Uncontrolled hypertension.
  • Patients with congenital long QT syndrome, QTcF interval QTcF > 480 msec (the QT interval values must be corrected for heart rate by Fridericia's formula [QTcF]).
  • Any history of ventricular fibrillation or torsade de pointes.
  • Symptomatic bradycardia defined as heart rate (HR) < 50 bpm with associated dizziness/syncope.
  • Left ventricular ejection fraction < 30%.
  • No patients who have received targeted (non-monoclonal antibodies [mAb]) or investigational agents within 2 weeks prior to rgistration and who have not recovered from side effects of those therapies.
  • No patients who have undergone major surgery ≤ 2 weeks prior to registration or who have not recovered from the side-effects of surgery.
  • No known medical condition causing an inability to swallow oral formulations of agents.
  • No active bacterial, viral or fungal infection (s) present.
  • Patients cannot have a Child-Pugh score greater than 1 (absent ascites, total bilirubin < 2, international normalized ratio (INR) <1.7 (unless on anticoagulation), and no encephalopathy; esophageal or gastric varices, and cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
  • No presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill inclusion criteria.
  • No evidence of active mucosal or internal bleeding.
  • No known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belamaf or drugs chemically related to belamaf, or any of the components of the study treatment.
  • Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or active plasma cell leukemia at the time of screening.
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment. Participant must not have current corneal epithelial disease except mild changes in corneal epithelium. For belantamab mafodotin, concomitant administration with strong inhibitors of OATP should be avoided.
  • RE-REGISTRATION ELIGIBILITY CRITERIA: Patients must meet criteria for progression of myeloma as defined by IMWG criteria indicated as any of the following:
  • ≥ 25% increase in M-protein (must be at least 0.5 g/dl above nadir from last treatment regimen).
  • 25% difference between involved and uninvolved serum free light chains from its nadir or
  • The development of new plasmacytomas or hypercalcemia not due to other causes. In the absence of progression by serum M protein or free light chain, biopsy of new plasmacytoma of extramedullary disease is warranted.
  • If refractory myeloma, it should be defined by IMWG criteria as disease which has become non-responsive or progressive on belamaf/dexamethasone.
  • RE-REGISTRATION ELIGIBILITY CRITERIA: Measurable disease defined by IMWG criteria as:
  • Serum M-protein ≥ 0.5 g/dL.
  • Urine monoclonal protein ≥ 200 mg/24h.
  • Serum FLC assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) and serum free light chain ratio is abnormal.
  • PET/CT or MRI findings consistent with (c/w) disease progression.
  • RE-REGISTRATION ELIGIBILITY CRITERIA: Absolute neutrophil count (ANC) ≥ 1,000/mm^3.
  • RE-REGISTRATION ELIGIBILITY CRITERIA: Platelet Count ≥ 75,000/mm^3 (or ≥ 50,000/mm^3 if BM plasma cells > 50%).
  • RE-REGISTRATION ELIGIBILITY CRITERIA: Calc. creatinine clearance ≥ 30 mL/min using Cockcroft-Gault equation.
  • RE-REGISTRATION ELIGIBILITY CRITERIA: Total bilirubin ≤ 2 mg/dL.
  • RE-REGISTRATION ELIGIBILITY CRITERIA: AST/ALT ≤ 2.5 x upper limit of normal (ULN).
  • RE-REGISTRATION ELIGIBILITY CRITERIA: Alkaline phosphatase ≤ 3 x ULN.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • OhioHealth O'Bleness Hospital

    Athens, Ohio, 45701

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Columbus Oncology and Hematology Associates

    Dublin, Ohio, 43016

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • OhioHealth Pickerington Methodist Hospital

    Pickerington, Ohio, 43147

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Saint Vincent Hospital Cancer Center at Sheboygan

    Sheboygan, Wisconsin, 53081

  • Sheboygan Physicians Group

    Sheboygan, Wisconsin, 53081

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235-1495

  • ProHealth Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

  • OhioHealth Westerville Medical Campus/Westerville Cancer Center

    Westerville, Ohio, 43082

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

Other trials in United States

About this study

Official title: A Phase I/II Study of the Safety, Tolerability and Efficacy of Belantamab Mafodotin (GSK2857916) in Combination With Iberdomide (CC-220)/Dexamethasone Versus Belantamab Mafodotin (GSK2857916)/Dexamethasone in Relapsed Refractory Multiple Myeloma

This phase I/II trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Multiple myeloma is a cancer that affects white blood cells called plasma cells, which are made in the bone marrow and are part of the immune system. Multiple myeloma cells have a protein on their surface called B-cell maturation antigen (BCMA) that allows the cancer cells to survive and grow. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Belantamab mafodotin has been designed to attach to the BCMA protein, which may cause the myeloma cell to become damaged and die. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine maximum tolerated dose (MTD) of iberdomide (CC-220) in combination with belantamab mafodotin and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM). (PHASE I) II. To determine whether the combination of belantamab mafodotin/ iberdomide/dexamethasone improves progression-free survival (PFS) relative to belantamab mafodotin/dexamethasone in patients with RRMM. (PHASE II)

SECONDARY OBJECTIVES:

  1. To summarize the incidence and cause for treatment delays, modifications and omissions. (PHASE I) II. To assess treatment response. (PHASE I) III. To obtain an estimate of the progression-free survival (PFS) and overall survival (OS) distribution. (PHASE I) IV. To determine minimal residual disease (MRD) negativity. (PHASE I) V. To observe and record anti-tumor activity. (PHASE I) VI. To determine whether the combination of belantamab mafodotin/ iberdomide/dexamethasone improves overall survival (OS) compared to belantamab mafadotin/dexamethasone in patients with RRMM. (PHASE II) VII. To evaluate the safety profile. (PHASE II) VIII. To estimate the ORR (per International Myeloma Working Group [IMWG] criteria), duration of response (DoR), and time to relapse (TTR). (PHASE II) XI. To determine MRD status. (PHASE II)

EXPLORATORY OBJECTIVES:

  1. To examine changes in T, NK, and B-cell subsets and quantitative immunoglobulin levels after 1, 3, 6 and 12 cycles of treatment.

II. To investigate whether BCMA protein expression on MM cells at diagnosis as well as at relapse or end of study (including loss of expression) is associated with outcome (OS and PFS).

OUTLINE: This is a phase I, dose-escalation study of iberdomide followed by a phase II study.

PHASE I: Patients receive iberdomide orally on days 1-21 and 29-49, belantamab mafodotin intravenously (IV) on day 1, and dexamethasone orally (PO) on days 1, 8, 15, 22, 29, 36, 43, and 50 of each cycle. Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) during screening as clinically indicated and computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scans during screening and as clinically indicated on study. Patients also undergo a bone marrow biopsy and aspiration and blood sample collection throughout trial.

PHASE II: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive belantamab mafodotin IV on day 1 and dexamethasone PO on days 1, 8, 15, 22, 29, 36, 43, and 50 of each cycle. Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients who progress may cross over to Arm II. Patients undergo ECHO during screening as clinically indicated and CT, MRI and/or PET scans during screening and as clinically indicated on study. Patients also undergo a bone marrow biopsy and aspiration and blood sample collection throughout trial.

ARM II: Patients receive iberdomide orally on days 1-21 and 29-49, belantamab mafodotin IV on day 1, and dexamethasone PO on days 1, 8, 15, 22, 29, 36, 43, and 50 of each cycle. Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening as clinically indicated and CT, MRI and/or PET scans during screening and as clinically indicated on study. Patients also undergo bone marrow biopsy and aspiration and blood sample collection throughout trial.

After completion of study treatment, patients are followed up every 6 months for 3 years from study entry.

Being tested
Iberdomide, Belantamab Mafodotin, Dexamethasone, Echocardiography, Computed Tomography
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

    Receive PO

  • Belantamab MafodotinBiological

    Receive IV

  • DexamethasoneDrug

    Receive PO

  • EchocardiographyProcedure or surgery

    Undergo ECHO

  • Computed TomographyProcedure or surgery

    Also called CT Scan, CAT Scan

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called MRI

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called PET Scan

    Undergo PET

  • Bone Marrow BiopsyProcedure or surgery

    Undergo Bone Marrow Biopsy

  • Bone Marrow AspirationProcedure or surgery

    Undergo Bone Marrow Aspirate

  • Biospecimen CollectionProcedure or surgery

    Undergo blood sample collection

Study groups in NCT06232044
Study groupRoleWhat they receive
Phase I (iberdomide, belantamab mafodotin, dexamethasone)ExperimentalPatients receive iberdomide orally on days 1-21 and 29-49, belantamab mafodotin IV on day 1, and dexamethasone PO on days 1, 8, 15, 22, 29, 36, 43, and 50 of each cycle. Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening as clinically indicated and CT, MRI and/or PET scans during screening and as clinically indicated on study. Patients also undergo a bone marrow biopsy and aspiration and blood sample collection throughout trial.
Receives: Drug: Iberdomide; Biological: Belantamab Mafodotin; Drug: Dexamethasone; Procedure: Echocardiography; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Bone Marrow Biopsy; Procedure: Bone Marrow Aspiration; Procedure: Biospecimen Collection
Phase II, Arm I (belantamab mafodotin, dexamethasone)Active comparatorPatients receive belantamab mafodotin IV on day 1 and dexamethasone PO on days 1, 8, 15, 22, 29, 36, 43, and 50 of each cycle. Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients who progress may cross over to Arm II. Patients undergo ECHO during screening as clinically indicated and CT, MRI and/or PET scans during screening and as clinically indicated on study. Patients also undergo a bone marrow biopsy and aspiration and blood sample collection throughout trial.
Receives: Biological: Belantamab Mafodotin; Drug: Dexamethasone; Procedure: Echocardiography; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Bone Marrow Biopsy; Procedure: Bone Marrow Aspiration; Procedure: Biospecimen Collection
Phase II, Arm II (iberdomide, belantamab mafodotin)ExperimentalPatients receive iberdomide orally on days 1-21 and 29-49, belantamab mafodotin IV on day 1, and dexamethasone PO on days 1, 8, 15, 22, 29, 36, 43, and 50 of each cycle. Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening as clinically indicated and CT, MRI and/or PET scans during screening and as clinically indicated on study. Patients also undergo bone marrow biopsy and aspiration and blood sample collection throughout trial.
Receives: Drug: Iberdomide; Biological: Belantamab Mafodotin; Drug: Dexamethasone; Procedure: Echocardiography; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Bone Marrow Biopsy; Procedure: Bone Marrow Aspiration; Procedure: Biospecimen Collection

What is being measured

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

  1. Maximum tolerated dose (MTD) of iberdomide (Phase I)

    MTD will be defined as the highest dose level among those tested where at most one out of 6 patients develops a DLT prior to the start of their second cycle of treatment. Will be assessed by NCI CTCAE v 5.0.

    Measured: During the first cycle of therapy, up to 28 days

  2. Progression-free survival (PFS) (Phase II)

    Will be compared between the two treatment arms. the methods of Kaplan and Meier will be used to graphically evaluate these distributions as well as to estimate the median PFS and corresponding 95% confidence intervals.

    Measured: From randomization to the time of documented disease progression and/or death due to any cause, assessed up to 3 years

Secondary outcomes (5)

  1. Rate of grade 3+ Adverse Events (AEs)

    Will be collected and graded according to the NCI CTCAE v 5.0 criteria.

    Measured: Up to 3 years

  2. Complete response (CR) rate

    Will be estimated for each treatment arm and calculated as the number of patients with CR divided by the total number of patients randomized. For each treatment arm, CR rates will be estimated with their 95% confidence intervals.

    Measured: up to 3 years

  3. Overall response rate (ORR)

    : Overall response includes complete, very good partial, and partial responses. ORR will be estimated for each treatment arm and calculated as the number of patients with response divided by the total number of patients randomized. For each treatment arm, ORRs will be estimated with their 95% confidence intervals.

    Measured: up to 3 years

  4. Duration of response (DoR)

    : DoR will be calculated for patients with a complete, very good partial, or partial response from the first date of response until the earlier of disease progression, death from any cause, or non-protocol myeloma-directed therapy to treat residual or progressive disease. Patients alive and progression-free at the date of last known clinical assessment or at the last assessment date prior to beginning a non-protocol myeloma-directed therapy for reasons other than residual or progressive disease will be censored. The Kaplan-Meier method will be used to estimate duration of response for each treatment arm.

    Measured: p to 3 years

  5. Overall Survival (OS)

    OS will be calculated from randomization date until death from any cause, censoring patients alive at the date of last contact. The Kaplan-Meier method will be used to estimate OS for each treatment arm.

    Measured: Up to 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 posted30 Jan 2024
  2. Study start23 Apr 2025
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 Aug 2030 (estimated)

Why it stopped: Enrollment to Dose Level 1 cohort has been met

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
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06232044
Sponsor's protocol ID
A062101
Other IDs
NCI-2023-09710
Status last verified
Oct 2026
First submitted
22 Jan 2024
Last updated
2 Oct 2026
Results posted
No
FDA-regulated drug
No
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, Belantamab Mafodotin and Dexamethasone in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by Alliance for Clinical Trials in Oncology at 43 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?

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: paused, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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?

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?

Maximum tolerated dose (MTD) of iberdomide (Phase I) (time frame: During the first cycle of therapy, up to 28 days). 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 NCT06232044.

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 2 Oct 2026.

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