Is NCT05898646 recruiting in Scottsdale, AZ?

Yes, NCT05898646 is currently recruiting participants at its Scottsdale, AZ location. This light chain amyloidosis clinical trial is actively enrolling qualified participants.

How do I join the light chain amyloidosis clinical trial in Scottsdale?

To join this clinical trial in Scottsdale, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Scottsdale clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Light Chain Amyloidosis Clinical Trial in Scottsdale, AZ

About This Light Chain Amyloidosis Study in Scottsdale

This phase II trial compares shorter-duration versus longer-duration maintenance therapy with daratumumab for improving survival in patients who have received initial treatment with daratumumab for light chain (AL) amyloidosis. Maintenance therapy is treatment that is given to help keep cancer from coming back after it has disappeared following initial therapy. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types o

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age \>= 18 years

Histological confirmation of AL amyloidosis with adequate typing (mass spectrometry, immunohistochemistry, immunofluorescence, immunogold)

AL amyloidosis with organ disease requiring therapy

NOTE: Disease requiring therapy is referred to the time of diagnosis. There are no limitations in baseline measurable disease parameters

Patients must have monoclonal protein studies (serum free light chain assay, serum immunofixation or serum MASS-FIX) obtained at time of diagnosis before induction therapy initiated and available for review to be enrolled.

NOTE: Patients are allowed to participate in this study if urine electrophoresis immunofixation study was not done at time of diagnosis or cannot be obtained

Patients must have completed 6 cycles of daratumumab (Dara)-CyBorD-based induction treatment prior to registration or have a plan to complete cycle 6 prior to cycle 1 day 1. NOTE: treatment in the study is allowed only after the completion of 6 cycles of induction

Patients must have achieved a hematological complete response (CR) (irrespective of organ response achievement) or hematological very good partial response (VGPR) (irrespective of organ response achievement) or hematological low-difference in involved and uninvolved free light chain (dFLC) partial response (PR) (irrespective of organ response achievement) or hematological PR with at least one organ response after receiving Dara-CyBorD-based induction.

NOTE: Patients with baseline dFLC \< 5 mg/dL, must have achieved hematological CR, or dFLC \< 1 mg/dL or achieved organ response prior to randomization

Patients in whom bortezomib and/or cyclophosphamide were omitted from induction due to toxicity concerns or adverse effects are allowed. Patients must receive at least daratumumab and dexamethasone at induction to qualify for the study

NOTE: Dexamethasone use does not need to be carried to end of induction for eligibility consideration

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3

Hemoglobin \>= 8.0 g/dL (obtained =\< 28 days prior to registration)

Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 28 days prior to registration)

Platelet count \>= 50,000/mm\^3 (obtained =\< 28 days prior to registration)

Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only.

NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Provide written informed consent

NOTE: Informed consent required =\< 90 days prior registration

Ability to complete questionnaire(s) by themselves or with assistance

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria

Any of the following because this study involves an agent that has possible genotoxic, mutagenic and teratogenic effects:

Pregnant persons

Nursing persons

Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception

Received \>1 cycle of daratumumab maintenance after end of induction therapy and prior to registration

Multiple myeloma at time of diagnosis as defined by any of the following:

Hypercalcemia: Serum calcium \> 1 mg/dL higher than upper limit of normal or \> 11 mg/dL

Renal insufficiency: Creatinine clearance \< 40 mL per min or serum creatinine \> 2 mg/dL attributed to high circulating light chains (i.e. cast nephropathy) or hypercalcemia

Anemia: Hemoglobin \> 2 g/dL below lower limit of normal, or \< 10 g/dL, attributed to high marrow myeloma infiltration

Bone lesions: \>= 1 osteolytic lesion on skeletal x-ray, computed tomography (CT), or positron emission tomography (PET)-CT (bone imaging is not mandatory but based on clinical suspicion)

Clonal bone marrow plasma cells \>= 60%

\> 1 focal lesion on magnetic resonance imaging (MRI) (MRI is not mandatory but based on clinical suspicion)

If bone imaging (CT, MRI, PET-CT) was not done at time of diagnosis it is not needed to be performed at registration to rule out bone disease

\>= 40% BMPCs irrespective of the above

The study will allow patients with involved: uninvolved serum-free light chain (sFLC) ratio \>= 100 if this is the only criteria that defines amyloidosis if all the above criteria are not met

Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Note: Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR

Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.

NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial

Uncontrolled intercurrent illness including, but not limited to:

Ongoing or active infection

Unstable angina pectoris

Psychiatric illness/social situations that would limit compliance with study requirements

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 Scottsdale?

Yes, this clinical trial (NCT05898646) has an active research site in Scottsdale, AZ 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.

Light Chain Amyloidosis Treatment Options in Scottsdale, AZ

If you're searching for light chain amyloidosis treatment options in Scottsdale, AZ, this clinical trial (NCT05898646) 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 Scottsdale research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced light chain amyloidosis 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 light chain amyloidosis clinical trials near you to find additional studies recruiting in your area.

Light Chain Amyloidosis Clinical Trial in Scottsdale, AZ

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