Daratumumab for Multiple Myeloma

Recruiting at 123 trial locations

Overseen By Study Contact

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: Daratumumab

Disqualifiers: Allergies, Investigational vaccines, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Duration: 3 years 7 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of daratumumab (also known as Darzalex) for individuals with multiple myeloma, a type of blood cancer. It aims to maintain access to this drug for those already benefiting from it in other studies. Participants will receive daratumumab alone or with other standard treatments, depending on their previous regimen. Ideal candidates are those already receiving daratumumab in specific studies, without major side effects or disease progression. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential approval of a promising treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have taken any disallowed therapies between the completion of the parent study and the start of this study.

Is there any evidence suggesting that daratumumab is likely to be safe for humans?

Research has shown that daratumumab is generally well-tolerated by people with multiple myeloma. One study found that both the IV (through a vein) and subcutaneous (under the skin) forms of daratumumab worked similarly in treating the disease. The most common side effect when using daratumumab alone was upper respiratory tract infections, occurring in about 20% of patients. Another study found that infections occurred in about 77.5% of patients who received daratumumab alone. Daratumumab has been FDA-approved since 2015, indicating a strong understanding of its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about daratumumab for multiple myeloma because it offers a unique approach compared to existing treatments. Unlike traditional therapies, daratumumab is a monoclonal antibody that specifically targets the CD38 protein on myeloma cells, which can lead to more precise and effective elimination of cancer cells. Another standout feature is its flexible delivery method, with options for intravenous or subcutaneous administration, potentially enhancing patient convenience and comfort. These innovative aspects make daratumumab a promising option for improving outcomes in multiple myeloma patients.

What is the effectiveness track record for daratumumab in treating multiple myeloma?

Studies have shown that daratumumab effectively treats multiple myeloma, a type of blood cancer. One study found that a treatment plan including daratumumab led to 95% of patients experiencing no cancer progression after four years. Other research has shown that patients taking daratumumab had similar success rates to those using the intravenous form, with 91.7% responding well to the treatment. In this trial, participants will receive daratumumab either as monotherapy or in combination with standard care treatments. Daratumumab also enabled more patients to undergo stem cell transplants compared to standard treatments. These findings suggest that daratumumab can be a strong option for managing multiple myeloma. ^{1 3 6 7 8}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with multiple myeloma or smoldering multiple myeloma who are benefiting from ongoing Janssen R&D studies involving daratumumab. Participants must not be pregnant, agree to contraception, have signed an informed consent form, and adhere to lifestyle restrictions. They should continue to benefit from the treatment without disease progression or unmanageable toxicity.

Inclusion Criteria

Willing and able to adhere to the lifestyle restrictions specified in this protocol

I am a woman who can have children, have tested negative for pregnancy, and agree to ongoing pregnancy tests.

I agree not to donate sperm during and for 3 months after the study.

Exclusion Criteria

I have not taken any treatments not allowed by this study since my last study ended.

I haven't had any experimental or live vaccines in the last 4 weeks, except for COVID-19.

Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daratumumab as monotherapy or in combination with standards of care treatment

3 years 7 months

Monthly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years 7 months

Open-label extension

Participants continue to receive daratumumab treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Daratumumab

Trial Overview

The study provides access to treatments like Daratumumab (alone or with other drugs) for participants in previous trials where it showed benefits. It aims to allow continued use of these treatments and collect long-term safety data on their effectiveness against multiple myeloma.

How Is the Trial Designed?

Group I: Daratumumab Experimental Treatment 5 Interventions

Participants will receive a single dose of daratumumab 16 milligrams per kilograms (mg/kg) intravenous (IV) or 1800 mg subcutaneous (SC) infusion on Cycle 1 Day 1 (28-day cycle), as monotherapy or in combination with standards of care treatment (that is, pomalidomide and dexamethasone, lenalidomide and dexamethasone, carfilzomib and dexamethasone) or standards of care treatment alone, depending on the treatment received in the parent study. Participants who received daratumumab IV during the parent study, will have an option to switch to daratumumab SC on Day 1 of any cycle during this long-term extension study.

Daratumumab is already approved in European Union, United States for the following indications:

Approved in European Union as Darzalex for:

• Relapsed and refractory multiple myeloma
• Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone

Approved in United States as Darzalex for:

• Multiple myeloma in patients who have received at least three prior therapies
• Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
• Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Daratumumab, a monoclonal antibody targeting CD38, has been approved in the USA for treating multiple myeloma in patients who have undergone at least three prior therapies, demonstrating its role as a treatment option for difficult-to-treat cases.

In a phase II trial, daratumumab monotherapy showed an overall response rate of about 30% in patients with relapsed or refractory multiple myeloma, indicating its efficacy in this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: First Global Approval. McKeage, K.[2018]

Daratumumab is a monoclonal antibody that effectively targets CD38 on multiple myeloma cells, leading to cell death through various mechanisms such as complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity.

It has shown a favorable safety profile and significant clinical activity as both a standalone treatment and in combination with lenalidomide for patients with relapsed multiple myeloma who have not responded to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: monoclonal antibody therapy to treat multiple myeloma. Xia, C., Ribeiro, M., Scott, S., et al.[2018]

Daratumumab, a monoclonal antibody targeting CD38, has shown significant efficacy as a monotherapy in relapsed/refractory multiple myeloma, achieving an overall response in about one-third of patients, with rapid and durable effects.

In combination with other treatments like bortezomib or lenalidomide, daratumumab significantly prolonged progression-free survival, although the overall survival benefit is still being evaluated, and it was generally well tolerated with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma. Blair, HA.[2018]

Intravenous daratumumab, when combined with bortezomib, thalidomide, and dexamethasone, significantly improves treatment outcomes for adults with newly diagnosed multiple myeloma, leading to higher rates of stringent complete response and prolonged progression-free survival, as shown in the phase III CASSIOPEIA trial.

The addition of daratumumab has a minimal impact on overall toxicity, with the most common serious side effects being blood-related issues, indicating it is a relatively safe option for patients undergoing treatment for multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: A Review in Combination Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma. Lamb, YN.[2021]

Daratumumab received conditional marketing authorization in the EU for treating relapsed and refractory multiple myeloma, showing an overall response rate of 29.2% in heavily pre-treated patients, indicating its efficacy as a monotherapy.

The drug was later approved for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone, demonstrating improved progression-free survival in patients who had received at least one prior therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma. Tzogani, K., Penninga, E., Schougaard Christiansen, ML., et al.[2020]

Intravenous daratumumab, when combined with bortezomib, melphalan, and prednisone, significantly improves progression-free survival in patients with newly diagnosed multiple myeloma who cannot undergo autologous stem cell transplantation, as shown in the phase 3 ALCYONE trial.

The addition of daratumumab does not increase overall toxicity compared to the standard treatment, although it may lead to more infusion-related reactions and infections, making it a promising and relatively safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: A Review in Combination Therapy for Transplant-Ineligible Newly Diagnosed Multiple Myeloma. Syed, YY.[2021]

Citations

1.

jnj.com

jnj.com/media-center/press-releases/darzalex-faspro-daratumumab-and-hyaluronidase-fihj-based-regimen-shows-95-percent-progression-free-survival-at-four-years-in-transplant-eligible-newly-diagnosed-patients-with-multiple-myeloma-who-achieved-sustained-mrd-negativity

DARZALEX FASPRO® (daratumumab and hyaluronidase ...

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant- ...

2.

darzalex.com

darzalex.com/clinical-results/

Clinical Results

A study confirmed that DARZALEX FASPRO ® gave patients results comparable to the IV formulation of DARZALEX ® in treating multiple myeloma when used by itself.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12141371/

Real-world data on the use of subcutaneous daratumumab ...

As of the data cutoff (August 8, 2023), 49 patients were included. By the end of consolidation, 91.7% of patients achieved an overall response ( ...

4.

cancer.gov

cancer.gov/news-events/cancer-currents-blog/2024/multiple-myeloma-darzalex-plus-vrd

Daratumumab Plus Standard Therapy for Multiple Myeloma

Slightly more patients in the daratumumab group than the standard treatment group were able to receive a stem cell transplant (90% versus 87%).

5.

jnjmedicalconnect.com

jnjmedicalconnect.com/products/darzalex-faspro/medical-content/darzalex-darzalex-faspro-retreatment

DARZALEX + DARZALEX FASPRO - Retreatment

Treatment patterns and effectiveness of patients with multiple myeloma initiating Daratumumab across different lines of therapy: a real-world ...

6.

darzalexhcp.com

darzalexhcp.com/frontline-dvrd/

Frontline DVRd - darzalex faspro

In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO® monotherapy is upper respiratory tract infection. The most common adverse ...

7.

jnjmedicalconnect.com

jnjmedicalconnect.com/products/darzalex/medical-content/darzalex-darzalex-faspro-adverse-event-infections-in-patients-with-newly-diagnosed-multiple-myelo

DARZALEX + DARZALEX FASPRO - Adverse Event

Results - Safety - Infection-Related Events in Part 2 · Infections occurred in 77.5% (n=341) of patients in the DARZALEX monotherapy arm vs 64% ( ...

8.

myeloma.org

myeloma.org/blog/fda-odac-supports-darzalex-faspro-for-hr-smm

FDA ODAC Supports Use of Darzalex Faspro for HR-SMM

DARZALEX® (daratumumab), a similar version given intravenously (IV), was approved in 2015 and is also used in newly diagnosed myeloma patients.