Daratumumab After Stem Cell Transplant for Multiple Myeloma

Recruiting at1 trial location

Overseen by Amrita Y. Krishnan

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well daratumumab after a stem cell transplant works in treating patients with multiple myeloma. Monoclonal antibodies, such as daratumumab, may kill cancer cells that are left after chemotherapy.

Research Team

Amrita Y. Krishnan

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for patients with multiple myeloma who have adequate organ function, no severe asthma or uncontrolled diseases, and are not pregnant. They must understand the study and agree to use birth control. Participants should be within 2-13 months of their first therapy for multiple myeloma and have a sufficient number of stem cells collected for transplant.

Inclusion Criteria

I am scheduled for a stem cell transplant with a specific chemotherapy dose, adjusted for my kidney function.

My organs are strong enough for high dose chemotherapy and a stem cell transplant.

I have been diagnosed with multiple myeloma, amyloidosis included.

Exclusion Criteria

I've been cancer-free for 5 years, except for minor skin cancers or early-stage prostate or breast cancer.

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

You have known allergies or sensitivity to certain types of medications made from human proteins.

Treatment Details

Interventions

• Daratumumab (Monoclonal Antibodies)

Trial Overview The trial tests daratumumab's effectiveness following a stem cell transplant in treating multiple myeloma. Daratumumab is an antibody that may destroy remaining cancer cells post-chemotherapy. The study includes autologous stem cell transplantation, melphalan chemotherapy, and biomarker analysis.

Participant Groups

Group I: Treatment (ASCT, melphalan, daratumumab) Experimental Treatment 4 Interventions

Patients undergo standard of care ASCT with a conditioning regimen of melphalan. Beginning 60-120 days after ASCT, patients receive daratumumab IV every week for 8 weeks, every 2 weeks for 16 weeks, and then every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School