NCT05922501

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
55mo left

Started May 2024

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
May 2024Dec 2030

First Submitted

Initial submission to the registry

June 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

May 31, 2024

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

4.6 years

First QC Date

June 19, 2023

Last Update Submit

January 12, 2026

Conditions

Relapsed CancerRefractory Multiple MyelomaMultiple Myeloma

Keywords

Relapsed/RefractoryMultiple MyelomaRelapsed and Refractory

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    Evaluated per International Myeloma Working Group Response Criteria

    4 weeks

Secondary Outcomes (3)

  • Number of Adverse Events

    4 weeks

  • Progression Free Survival (PFS)

    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)

    4 weeks

Study Arms (1)

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.

Drug: IsatuximabDrug: Belantamab mafodotinDrug: PomalidomideDrug: Dexamethasone

Interventions

IsatuximabDRUG

An IgG1-derived monoclonal antibody that targets CD38 proteins, administered intravenously.

Also known as: SAR650984
Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone
Belantamab mafodotinDRUG

An antibody-drug conjugate that is the combination of an antibody targeting BCMA and a drug, administered intravenously.

Also known as: GSK2857916
Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone
PomalidomideDRUG

An immunomodulatory agent, capsule taken orally.

Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone
DexamethasoneDRUG

A glucocorticoid which is a substance that stops inflammation cause by immune system disorders, tablet taken orally.

Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +13 more criteria

You may not qualify if:

  • 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.
  • 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
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

RecurrenceMultiple Myeloma

Interventions

isatuximabbelantamab mafodotinpomalidomideDexamethasone

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Andrew Yee, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Yee, MD

CONTACT

617-724-4000AYEE1@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2023

First Posted

June 28, 2023

Study Start

May 31, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US(2)