Recruiting EARLY_PHASE1 Multiple Myeloma

New treatment option for Multiple Myeloma

Official title 64Cu-LLP2A for Imaging Hematologic Malignancies

ClinicalTrials.gov ID: NCT06636175

What this study is testing

What is 64Cu-LLP2A?

64Cu-LLP2A is an investigational medicine, being studied as a potential treatment for multiple myeloma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older. Healthy volunteers may be eligible.

You may be able to join if

  • Healthy Volunteer:
  • Adult 18 years of age or older
  • Able to give informed consent.
  • Able to comprehend and willing to follow instructions for study procedures as called for by the protocol
  • Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
See the full eligibility criteria
Who can join
  • Healthy Volunteer:
  • Adult 18 years of age or older
  • Able to give informed consent.
  • Able to comprehend and willing to follow instructions for study procedures as called for by the protocol
  • Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
  • No illicit drug use or other inhaled drug use (including pharmacologic agents and illicit drugs) within the past year per self-reporting mechanisms.
  • No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions.
  • Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year)...
  • Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease:
  • Multiple Myeloma defined in accordance with the International Myeloma Working Group criteria
  • Low-grade lymphoma, including the following subtypes: follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia
  • Adult 18 years of age or older and able to provide informed consent
  • Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
  • No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions
  • Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year)...
  • Patients participating in imaging or therapeutic trials with investigational agents are eligible to participate

The study team makes the final eligibility decision.

Where it's taking place

  • St Louis, Missouri, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.