Study Details

Open

Daratumumab/rHuPh20 +/- Lenalidomide as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration

The purpose of this study is to compare a usual maintenance treatment for multiple myeloma (lenalidomide) to using the study drug (daratumumab/rHuPH20) plus the usual treatment. We want to learn if the addition of daratumumab/rHuPH20 to the usual treatment could help you live longer after your stem cell transplant. This study will help the study doctors find out if this different approach is better than the usual approach.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

Before you begin the treatment part of the study, your doctor will review the results of your exams, tests, and procedures. If you join the treatment part of the study, you will have more exams, tests, and procedures to closely monitor your safety and health. Most of these are included in the usual care you would get even if you were not in a study. The following exams, tests and procedures need to be done as part of this study to monitor your safety and health, but may not be included in your usual care: blood test for hepatitis B, bone marrow aspirates, questionnaires that ask about your physical and emotional well-being.

Incentives

You or your insurance provider will not have to pay for the daratumumab/rHuPH20 while you take part in this study. You and/or your insurance provider will not have to pay for exams, tests, and procedures done for research purposes only or that are covered by the study.

In-person visits:
20+

Phone or online visits:
8

Total length of participation:
Up to 15 years

Looking for Specific Volunteers

Able to participate:

You have a confirmed diagnosis of symptomatic multiple myeloma with measurable disease.
You do not have organ involvement by amyloidosis.
You do not have progressive disease.
Your multiple myeloma is not resistant to lenalidomide or daratumumab treatment.
You are acceptable for transplant or have completed autologous stem cell transplant within 180 days prior to study registration.

Not eligible if:

You have received any investigational agent within 14 days prior to study registration.
You have inadequate kidney and liver function.
You have moderate or severe persistent asthma.
You have had a prior autograft or allograft or prior organ transplant requiring immunosuppressive therapy.
You have an uncontrolled bacterial, viral, or fungal infection.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Sascha Tuchman
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Multiple Myeloma)
Transplant

IRB Number

19-2598

ClinicalTrials.gov

NCT04071457