Iberdomide for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+60 other locations

Overseen by Sascha Tuchman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: National Cancer Institute (NCI)

Must not be taking: Strong CYP3A4 inducers

Disqualifiers: Active infections, Allergy to iberdomide, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial compares iberdomide maintenance therapy to disease monitoring for improving survival in patients who have received idecabtagene vicleucel (a type of chimeric antigen receptor T-cell \[CAR-T\] therapy) for multiple myeloma. The usual approach after treatment with idecabtagene vicleucel is to monitor the multiple myeloma without giving myeloma medications. There is currently no medication approved specifically for use after idecabtagene vicleucel treatment. Upon administration, iberdomide modifies the immune system and activates immune cells called T-cells, which could enhance the effectiveness of idecabtagene vicleucel. Iberdomide may keep multiple myeloma under control for longer than the usual approach (disease monitoring) after idecabtagene vicleucel, and may help multiple myeloma patients live longer.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you may need to switch from strong CYP3A4 inducers or inhibitors to a different medication and wait for a washout period (time without taking certain medications) before starting the trial.

What evidence supports the effectiveness of the drug Iberdomide for treating multiple myeloma?

Iberdomide, when combined with dexamethasone, has shown enhanced cancer-killing and immune-boosting effects in preclinical studies for multiple myeloma, especially in patients who have already tried many other treatments. ^{1 2 3 4 5}

Is Idecabtagene Vicleucel safe for humans?

Idecabtagene Vicleucel, a treatment for multiple myeloma, has shown some serious side effects in studies, including cytokine release syndrome (a severe immune reaction) and neurological issues in a small percentage of patients. While it has been approved for use, these potential risks mean it is important to discuss safety with your doctor. ^{6 7 8 9 10}

How is the treatment Idecabtagene Vicleucel different from other treatments for multiple myeloma?

Idecabtagene Vicleucel is a unique treatment for multiple myeloma because it is a CAR T-cell therapy, which means it uses modified immune cells to target and destroy cancer cells. This approach is different from traditional drugs and has shown significant improvements in response rates and survival for patients who have not responded to other treatments. ^{1 6 10 11 12}

Research Team

Sascha Tuchman, MD

Principal Investigator

Alliance for Clinical Trials in Oncology

Eligibility Criteria

This trial is for adults over 18 with multiple myeloma who've had CAR-T therapy (idecabtagene vicleucel) within the past 80-110 days. They should be in stable condition or better and haven't taken any other myeloma treatments since, except possibly short steroids for CAR-T side effects. People can't join if they're resistant to Iberdomide or have had certain recent therapies.

Inclusion Criteria

I am 18 years old or older.

Not pregnant and not nursing

ANC must be ≥ 1,500/mm^3

Exclusion Criteria

Known allergy to iberdomide

I have received treatment for multiple myeloma after ide-cel infusion.

Patient living outside the US

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients receive iberdomide orally once daily on days 1-21 of each 28-day cycle or undergo disease monitoring at monthly clinic visits.

Up to 4 years

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

4 years

Every 3-6 months (in-person)

Treatment Details

Interventions

• Iberdomide (Other)
• Idecabtagene Vicleucel (CAR T-cell Therapy)

Trial Overview The study compares maintenance therapy using a drug called Iberdomide against just monitoring the disease after CAR-T treatment for multiple myeloma. The goal is to see if Iberdomide helps patients live longer by keeping cancer under control better than no further treatment.

Participant Groups

Group I: Group II (iberdomide) Experimental Treatment 8 Interventions

Patients receive iberdomide PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy throughout the trial, undergo collection of blood samples at screening and on study, and undergo PET/CT and/or skeletal survey x-ray, CT, or MRI at screening and then as clinically indicated.

Group II: Group 1 (monitoring) Active Control 8 Interventions

Patients undergo disease monitoring at monthly clinic visits until disease progression. Patients also undergo bone marrow aspiration and biopsy throughout the trial, undergo collection of blood samples at screening and on study, and undergo PET/CT and/or skeletal survey x-ray, CT, or MRI at screening and then as clinically indicated.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Houston Methodist Hospital Houston, TX

Mercy Medical Center - Des Moines Des Moines, IA

UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, CA

Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, MS

More Trial Locations

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14080

Patients Recruited

41,180,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial. Lonial, S., Popat, R., Hulin, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. Richardson, PG., Oriol, A., Beksac, M., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I/II study of ixazomib, pomalidomide, and dexamethasone for lenalidomide and proteasome inhibitor refractory multiple myeloma (Alliance A061202). Voorhees, PM., Suman, VJ., Tuchman, SA., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of relapsed and relapsed refractory myeloma. Kastritis, E., Mitsiades, CS., Dimopoulos, MA., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing next generation immunomodulatory drugs and their combinations in multiple myeloma. Thakurta, A., Pierceall, WE., Amatangelo, MD., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. Munshi, NC., Anderson, LD., Shah, N., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial. Lin, Y., Raje, NS., Berdeja, JG., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Idecabtagene vicleucel (ide-cel) CAR T-cell therapy for relapsed and refractory multiple myeloma. Anderson, LD.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma. Sharma, P., Kanapuru, B., George, B., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma: Real-World Experience From the Myeloma CAR T Consortium. Hansen, DK., Sidana, S., Peres, LC., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma. Rodriguez-Otero, P., Ailawadhi, S., Arnulf, B., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect treatment comparison of idecabtagene vicleucel versus conventional care in triple-class exposed multiple myeloma. Shah, N., Mojebi, A., Ayers, D., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A phase I/II study of ixazomib, pomalidomide, and dexamethasone for lenalidomide and proteasome inhibitor refractory multiple myeloma (Alliance A061202). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Management of relapsed and relapsed refractory myeloma. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Developing next generation immunomodulatory drugs and their combinations in multiple myeloma. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Idecabtagene vicleucel (ide-cel) CAR T-cell therapy for relapsed and refractory multiple myeloma. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma: Real-World Experience From the Myeloma CAR T Consortium. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Indirect treatment comparison of idecabtagene vicleucel versus conventional care in triple-class exposed multiple myeloma. [2022]