Daratumumab Combination Therapy for Multiple Myeloma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Arkansas

Disqualifiers: Hypertension, Diabetes, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess whether adding one of the newest multiple myeloma therapies, daratumumab, into the Total Therapy approach helps patients live longer with fewer side effects

Research Team

Frits van Rhee

Principal Investigator

University of Arkansas for Medical Science-Myeloma Institute

Eligibility Criteria

Adults aged 18-75 with newly diagnosed active Multiple Myeloma requiring treatment, who haven't had more than four cycles of MM therapy. Must have high-risk disease indicators like a specific risk score or primary plasma cell leukemia, adequate organ function, and agree to use contraception if of childbearing potential.

Inclusion Criteria

I can care for myself, but my movement may be limited due to bone disease from multiple myeloma.

My kidney function and liver enzymes are within the required limits.

I have been recently diagnosed with active Multiple Myeloma needing treatment.

Exclusion Criteria

I haven't had cancer before, except for certain skin cancers or cervical cancer that's been treated, or any other cancer I haven't been treated for in the last year.

Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration.

My condition is not considered high-risk.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive induction chemotherapy with Carfilzomib, Thalidomide, Dexamethasone, Daratumumab, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide

8-12 weeks

Autologous Stem Cell Transplant (ASCT) 1

Participants undergo the first autologous stem cell transplant with Melphalan and Dexamethasone

4 weeks

Immunological Consolidation 1

Participants receive immunological consolidation with Daratumumab

4 weeks

Consolidation 1

Participants receive consolidation therapy with Daratumumab, Carfilzomib, and Dexamethasone

4 weeks

ASCT 2 (optional)

Participants may undergo a second autologous stem cell transplant with Melphalan and Dexamethasone

4 weeks

Immunological Consolidation 2

Participants receive a second round of immunological consolidation with Daratumumab

4 weeks

Maintenance

Participants receive maintenance therapy alternating between Dara-KD and Dara-RD in 3-month blocks

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Daratumumab

Trial Overview The trial is testing the addition of daratumumab to the Total Therapy approach for multiple myeloma. It aims to see if this new combination helps patients live longer with fewer side effects compared to current treatments.

Participant Groups

Group I: Study Treatment Experimental Treatment 12 Interventions

Induction Chemotherapy: Carfilzomib, Thalidomide, Dexamethasone, Daratumumab , CisPlatin, Adriamycin, Cyclophosphamide and Etoposide (KTD-Dara-PACE). Autologous Stem Cell Transplant (ASCT) 1: Melphalan, Dexamethasone, ASCT. Immunological Consolidation 1: Daratumumab. Consolidation 1: Daratumumab, Carfilzomib, Dexamethasone (Dara-KD). ASCT 2 (optional): Melphalan, Dexamethasone, ASCT. Immunological Consolidation 2: Daratumumab. Maintenance: Dara-KD alternating with Daratumumab, lenalidomide, and Dexamethasone (Dara-RD) in 3-month blocks. Bortezomib may be substituted for carfilzomib throughout the regimen at the discretion of the treating physician.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Janssen, LP

Industry Sponsor

Trials

169

Recruited

329,000+

Founded

1953

Headquarters

Beerse, Belgium

Known For

Mental Health Therapies

Top Products

Imodium, Remicade, Invega, Procrit

Joaquin Duato

Janssen, LP

Chief Executive Officer since 2022

MBA from ESADE Business School

Biljana Naumovic

Janssen, LP

Chief Medical Officer since 2023

MD from Belgrade University Medical School