Relapsed CancerPhase 2ISABELANCT05922501

Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma

A Phase 2 study testing Isatuximab, Belantamab mafodotin and Pomalidomide in people with Relapsed Cancer and Refractory Multiple Myeloma, run by Massachusetts General Hospital 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

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Trial summary

The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed Cancer, Refractory Multiple Myeloma, Multiple Myeloma
What is being tested?: Isatuximab, Belantamab mafodotin and Pomalidomide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 2 sitesUnited States
Study dates: 31 May 2024to 31 Dec 2030
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

Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).
Age ≥ 18 years
Measurable disease of multiple myeloma as defined by at least one of the following:
Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis

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Involved serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free light chain ratio
Previously treated relapsed and refractory multiple myeloma:
Patients must have received at least one prior line of therapy;
Prior therapy must include at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen); and
Disease progression on or within 60 days of completion of last therapy.
ANC ≥ 1000/μL. G-CSF is not permitted within 14 days of screening. Patients with ANC <1000/µL can be considered for screening on a case-by-case basis with additional monitoring, after discussion with and approval from the PI.
Platelet count ≥ 75,000/µL. Platelet transfusion is not permitted within 7 days of screening.
Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria.
Calculated creatinine clearance of ≥ 30 mL/min by Modified Diet in Renal Disease (MDRD) formula or Cockcroft-Gault formula
Spot urine (albumin/creatinine ratios (spot urine) < 500 mg/g or urine dipstick negative/trace.
Patient has adequate hepatic function, as evidenced by each of the following:
Serum bilirubin values < 1.5 × ULN. Isolated bilirubin ≥ 1.5 × ULN is acceptable if bilirubin is fractionated and direction bilirubin <35%. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin <3 mg/dL and normal direct bilirubin); and
Serum aspartate transaminase (ALT) and/or aspartate transaminase (AST) values < 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin <3 mg/dL and normal direct bilirubin).
Must be able to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin, apixaban, rivaroxaban, or equivalent.
All study 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.
Women of childbearing potential (WOCBP) must adhere to the scheduled pregnancy testing as required in the Pomalyst REMS program and agree to use a highly effective method of contraception during the study for 4 months after the last dose of treatment in the study (see Appendix) and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period). A WOCBP must have a negative highly sensitive serum pregnancy test within 72 hours before the first dose of study intervention and agree to use a highly effective method of contraception during the study and for 4 months after the last dose of belantamab mafodotin. Note: non childbearing potential 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.
A man who is sexually active with a WOCBP (even if they have undergone a successful vasectomy) must agree to use a barrier method of birth control e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for 6 months after receiving the last dose of study drug.
Male participants must refrain from donating sperm for 6 months after the last dose of study drug.
Able to swallow capsules whole (pomalidomide capsules cannot be crushed, dissolved or broken).

Who cannot join

Participant must not have had current corneal epithelial disease except mild changes in corneal epithelium.
Participant must not use contact lenses while participating in this study.
Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
Participants who are receiving any investigational agents.
Prior therapy with anti-CD38 monoclonal antibody within six months. No other multiple myeloma monoclonal antibody therapy within 30 days of start of study treatment.
Prior therapy with anti-BCMA therapy.

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Plasmapheresis within seven days prior to start of study treatment.
Primary refractory disease.
Concomitant high dose corticosteroids. Low dose corticosteroids (maximum dose prednisone 10 mg/day or equivalent) are permitted if given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc.
Pregnancy or lactation or planned lactation (breastfeeding).
Prior history of malignancies, other than MM, unless the patient has completed definitive treatment and has been free of the disease for ≥ 3 years. Patients who are free of disease < 3 years may enroll after discussion with and approval of the PI. Exceptions include the following (i.e. the following are eligible to participate):
Basal or squamous cell carcinoma of the skin
Carcinoma in situ of the cervix
Ductal carcinoma in situ of the breast
Incidental histologic finding of prostate cancer (T1a or T1b) managed with surveillance
Patients with active plasma cell leukemia at time of screening, POEMS syndrome, or primary AL amyloidosis are excluded from this trial.
Seropositive for HIV infection
Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]; see exception below). Subjects with resolved infection (i.e., 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 for hepatitis B virus (HBV) DNA levels. Those with positive HBV viral load 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 testing for HBV DNA.
Seropositive for hepatitis C (except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy).
Peripheral neuropathy ≥ grade 2 despite supportive therapy.
Hypersensitivity to isatuximab, belantamab mafodotin, pomalidomide, or dexamethasone, such as Stevens-Johnson syndrome. Rash to immunomodulatory drug that can be medically managed is allowed.
Allogeneic stem cell transplant <12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least four weeks prior to initiation of study treatment and who are currently dependent on such treatment. Patients may also not have active graft v. host disease (GVHD).
Autologous stem cell transplant <6 months prior to start of treatment
Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to:
Congestive heart failure (New York Heart Association [NYHA] Class 3 or 4)
Unstable angina
Clinically significant, uncontrolled cardiac arrhythmia such a 2nd degree or 3rd degree atrioventricular block
Recent (within the preceding 6 months) myocardial infarction or stroke
Uncontrolled hypertension
Diabetes mellitus with > 2 episodes of ketoacidosis in the preceding 12 months
Chronic obstructive pulmonary disease (COPD) requiring > 2 hospitalizations in the preceding 12 months.
Unstable liver or biliary disease
Active bacterial, viral, or fungal infection
Patient has any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results.
Major surgery within 4 weeks prior to C1D1.
Live or live-attenuated vaccine within 30 days prior to C1D1.
Toxicity from previous anticancer therapy must resolve to baseline levels or to grade ≤1, except for alopecia and peripheral neuropathy.

Trial locations and contacts

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

Andrew Yee, MD contact

617-724-4000

AYEE1@mgh.harvard.edu

United States2 sites, 2 recruiting

Massachusetts General Hospital
Boston, Massachusetts, 02114
Andrew Yee, MD, 617-724-4000, AYEE1@mgh.harvard.edu
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Clifton C. Mo, MD, 617-582-7969, Clifton_Mo@DFCI.HARVARD.EDU
Recruiting

Other trials in United States

About this study

Official title: A Phase II Study of ISABELA: Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma

Read the detailed description

This is a phase II study of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. Approximately 50 participants will take part in this research study. The primary objective is determining the overall response rate of the treatment. Treatment is until progression, adverse events, or withdrawal of consent.

Conditions: Relapsed Cancer, Refractory Multiple Myeloma, Multiple Myeloma
Being tested: Isatuximab, Belantamab mafodotin, Pomalidomide, Dexamethasone
Keywords: Relapsed/Refractory, Multiple Myeloma, Relapsed and Refractory
Medical subject headings: Recurrence, Multiple Myeloma

What participants receive

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

IsatuximabDrug
Also called SAR650984
An IgG1-derived monoclonal antibody that targets CD38 proteins, administered intravenously.
Belantamab mafodotinDrug
Also called GSK2857916
An antibody-drug conjugate that is the combination of an antibody targeting BCMA and a drug, administered intravenously.
PomalidomideDrug
An immunomodulatory agent, capsule taken orally.
DexamethasoneDrug
A glucocorticoid which is a substance that stops inflammation cause by immune system disorders, tablet taken orally.

Study groups in NCT05922501
Study group	Role	What they receive
Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone	Experimental	Isatuximab will be given once daily into your vein (by intravenous infusion) over about 30-60 minutes. This will occur during cycle 1 (cycle equals 28 days) on days 1, 8, 15, and 22 and cycle 2 and onwards days 1 and 15. Belantamab mafodotin will be given once every 8 weeks into your vein (by intravenous infusion) over about 60 minutes after completion of isatuximab infusion. Pomalidomide will be taken orally once daily during days 1-21 of each cycle. Dexamethasone will be taken orally once daily during days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle. Drug diaries will be provided to participants to document information about taking pomalidomide and dexamethasone. Receives: Drug: Isatuximab; Drug: Belantamab mafodotin; Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

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

Overall Response Rate (ORR)
Evaluated per International Myeloma Working Group Response Criteria
Measured: 4 weeks

Secondary outcomes (3)

Number of Adverse Events
Adverse events will be classified and graded according to the CTCAE v.5.0. Frequencies of adverse events will be summarized on all patients who receive any study drug.
Measured: 4 weeks
Progression Free Survival (PFS)
PFS is defined as the time from start of treatment to disease progression or death from any cause. Patients who have not progressed or died are censored at the date last known progression-free. This is estimated using the Kaplan-Meier method.
Measured: The time from start of treatment to disease progression or death from any cause, for up to 10 years. Patients who have not progressed or died are censored at the date last known progression-free.
Overall survival (OS)
OS is defined as the time from start of treatment to death due to any cause or censored at date last known alive. This is estimated using the Kaplan-Meier method.
Measured: 4 weeks

Timeline

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

31 May 202431 Dec 2030

First posted28 Jun 2023
Study start31 May 2024
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relapsed CancerStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05922501
Sponsor's protocol ID: 23-183
Acronym: ISABELA
Status last verified: Jan 2026
First submitted: 19 Jun 2023
Last updated: 14 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of ISABELA: Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT05922501
Acronym / sponsor ID: ISABELA / 23-183
Conditions: Relapsed Cancer, Refractory Multiple Myeloma, Multiple Myeloma
Keywords: Relapsed/Refractory, Multiple Myeloma, Relapsed and Refractory
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Sanofi, GlaxoSmithKline
Study start: 31 May 2024 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2030 (estimated)
First posted: 28 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone	Experimental	Drug: Isatuximab, Drug: Belantamab mafodotin, Drug: Pomalidomide, Drug: DexamethasoneIsatuximab will be given once daily into your vein (by intravenous infusion) over about 30-60 minutes. This will occur during cycle 1 (cycle equals 28 days) on days 1, 8, 15, and 22 and cycle 2 and onwards days 1 and 15. Belantamab mafodotin will be given once every 8 weeks into your vein (by intravenous infusion) over about 60 minutes after completion of isatuximab infusion. Pomalidomide will be taken orally once daily during days 1-21 of each cycle. Dexamethasone will be taken orally once daily during days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle. Drug diaries will be provided to participants to document information about taking pomalidomide and dexamethasone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (28 listed)

Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).
Age ≥ 18 years
Measurable disease of multiple myeloma as defined by at least one of the following:
Previously treated relapsed and refractory multiple myeloma:

Key exclusion criteria (37 listed)

Participant must not have had current corneal epithelial disease except mild changes in corneal epithelium.
Participant must not use contact lenses while participating in this study.
Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
Participants who are receiving any investigational agents.
Prior therapy with anti-CD38 monoclonal antibody within six months. No other multiple myeloma monoclonal antibody therapy within 30 days of start of study treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IsatuximabAlso: SAR650984An IgG1-derived monoclonal antibody that targets CD38 proteins, administered intravenously.	Drug	Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone
Belantamab mafodotinAlso: GSK2857916An antibody-drug conjugate that is the combination of an antibody targeting BCMA and a drug, administered intravenously.	Drug	Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone
PomalidomideAn immunomodulatory agent, capsule taken orally.	Drug	Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone
DexamethasoneA glucocorticoid which is a substance that stops inflammation cause by immune system disorders, tablet taken orally.	Drug	Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone

Primary outcome

Overall Response Rate (ORR)
Time frame: 4 weeks
Evaluated per International Myeloma Working Group Response Criteria

3 secondary outcomes

Number of Adverse Events
Time frame: 4 weeks
Progression Free Survival (PFS)
Time frame: The time from start of treatment to disease progression or death from any cause, for up to 10 years. Patients who have not progressed or died are censored at the date last known progression-free.
Overall survival (OS)
Time frame: 4 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Andrew Yee, MD contact

617-724-4000

AYEE1@mgh.harvard.edu

Andrew Yee, MD principal investigator

Massachusetts General Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 28 inclusion and 37 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 14 Jan 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 Andrew Yee, MD (617-724-4000, AYEE1@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: 4 weeks). 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 NCT05922501.

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 14 Jan 2026.