Bethesda, MDNCT06103838Now EnrollingIRB Ready

Multiple Myeloma Clinical Trial in Bethesda, MD

Access cutting-edge multiple myeloma treatment through this phase 2 clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Cancer Institute (NCI)

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Expert Care in Bethesda

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related multiple myeloma treatment provided free

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Check if you qualify for this multiple myeloma clinical trial in Bethesda, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Multiple Myeloma Study in Bethesda

Background: Multiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier. Objective: To find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose. Eligibility: Adults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM). Design: Participants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET/CT scan takes images of their body. All participants will have 3 study visits. During each visit they will have: Two PET/CT scans. One with 18F-FDG, one with 18F-fluciclovine. An optional magnetic resonance imaging scan. A bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone. These tests may be spread over 30 days for each visit. NDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first. All participants will have a third study visit after 5 years or when their disease progresses.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \>= 3 g/dL and/or bone marrow plasma cells \>= 10% and at least one of the following:
Anemia: Hemoglobin \<=10 g/dL, or
Renal Failure: serum creatinine \>= 2.0 mg/dL, or
Hypercalcemia: Ca \>= 10.5 mg/dL, or
Lytic bone lesions on X-ray, CT, or PET/CT, or
\>= 2 focal lesions on spinal MRI, or
\>= 60% bone marrow plasma cells, or
Involved/un-involved serum free light chain ration \>= 100
Participants must have measurable disease defined by any one of the following:
Monoclonal bone marrow plasma cells \> 5%
Serum monoclonal protein \>= 0.2 g/dl
Urine monoclonal protein \> 200 mg/24 hr
Serum immunoglobulin free light chain \> 10 mg/dL AND abnormal kappa/lambda ratio
A measurable lesion on PET/CT or MRI
Participants fit criteria for one of the following categories:
Newly diagnosed multiple myeloma (NDMM)
Relapsed and/or refractory multiple myeloma (RRMM) with at least 1 prior line of therapy
Age \>=18 years.
ECOG performance status \<= 2
Negative serum or urine pregnancy test at screening for WOCBP.
Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine administration.
Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.
Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.
Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements.
Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT06103838) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Multiple Myeloma Treatment Options in Bethesda, MD

If you're searching for multiple myeloma treatment options in Bethesda, MD, this clinical trial (NCT06103838) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced multiple myeloma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all multiple myeloma clinical trials near you to find additional studies recruiting in your area.

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