Is NCT05363111 recruiting in Duarte, CA?

Yes, NCT05363111 is currently recruiting participants at its Duarte, CA location. This recurrent plasma cell myeloma clinical trial is actively enrolling qualified participants.

How do I join the recurrent plasma cell myeloma clinical trial in Duarte?

To join this clinical trial in Duarte, 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 Duarte 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.

Recurrent Plasma Cell Myeloma Clinical Trial in Duarte, CA

About This Recurrent Plasma Cell Myeloma Study in Duarte

This phase I trial tests the safety, side effects, and best dose of actinium Ac 225-DOTA-daratumumab (225Ac-DOTA-daratumumab) in combination with daratumumab and indium In 111-DOTA-daratumumab (111In-DOTA-daratumumab) in treating patients with multiple myeloma that does not respond to treatment (refractory) or that has come back (recurrent). Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab are forms of radioimmunotherapy in which a monoclonal antibody, daratumumab, has been linked to a radiotracer to allow for targeted delivery of the treatment to cancer cells. Giving all three together may kill more cancer cells.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines

Age \>= 18 years

Karnofsky performance status (KPS) \> 60%

Multiple myeloma according to International Myeloma Working Group (IMWG) criteria with measurable disease defined as one of the following:

Serum monoclonal protein \>= 1.0 g/dL (or 0.5 g/dL in patients with immunoglobulin A \[IgA\] multiple myeloma \[MM\])

24 hour urine monoclonal protein \>= 200 mg/24 hour

Serum free light chain (FLC) of \> 10 mg/dL and an abnormal kappa:lambda ratio

Minimum of two prior lines of therapy

Previously received treatment with all of the following: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Refractory (defined per IMWG Consensus Criteria) to daratumumab

CD38 expression on multiple myeloma (MM) cells from bone marrow aspirate or biopsy as demonstrated by flow cytometry or immunohistochemistry

Refractory (defined per IMWG Consensus Criteria) or intolerant to most recent therapy

Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 to prior anti-cancer therapy

Prior antitumor therapy must have been completed prior to enrollment as follows:

\>= 21 days for investigational agents, cytotoxic chemotherapy

\>= 21 days for radiation therapy. Note: Patients must have measurable disease that has been untreated/unaffected by local radiation therapy

\>= 3 months for prior anti-CD38-targeted therapy, adoptive cell therapy

\>=14 days for proteasome inhibitor therapy

\>= 7 days for immunomodulatory agents

Absolute neutrophil count (ANC) \>= 1,000/mm\^3 (within 14 days prior to day 1 of protocol therapy)

NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement

Platelets \>= 75,000/mm\^3 (\>= 50,000/mm\^3 if \>= 50% marrow involvement) (within 14 days prior to day 1 of protocol therapy)

NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement

Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 14 days prior to day 1 of protocol therapy)

Aspartate aminotransferase (AST) =\< 3 x ULN (within 14 days prior to day 1 of protocol therapy)

Alanine aminotransferase (ALT) =\< 3 x ULN (within 14 days prior to day 1 of protocol therapy)

Creatinine =\< 1.5 mg/dl AND/OR creatinine clearance of \>= 40 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)

Women of childbearing potential (WOCBP): negative urine or serum pregnancy test

If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (within 14 days prior to day 1 of protocol therapy)

Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods; condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (6 months after the last dose of 225Ac-DOTA-Daratumumab for women). A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion Criteria

Daratumumab or other anti CD38 antibody treatment \< 3 months prior to study enrollment

Prior radiopharmaceutical therapy

Detectable antibodies directed against daratumumab

Subject has received previous radiation to \> 25% of their bone marrow

Female patients who are lactating or have a positive pregnancy test during the screening period

Major surgery within 14 days prior to start of study treatment

Subject is receiving concurrent chemotherapy, radiation, or biologic for cancer treatment. Subject is receiving bone marrow stimulatory factors (e.g., granulocyte-macrophage colony-stimulating factor \[GM-CSF\]). Note: Hormonal therapy for someone with a history of cancer treated with curative intent is permitted if subject has been on hormonal therapy \> 1 year

Vaccination with live attenuated vaccines within 4 weeks of study agent administration

A diagnosis of primary amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, or POEMS

Severe persistent asthma (forced expiratory volume in 1 second \[FEV1\] \< 60% and/or daily symptoms) or severe chronic obstructive pulmonary disease (COPD) defined clinically or by historical pulmonary function tests with an FEV1 \< 50% predicted

Subject has known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or investigator's brochure). Patients with a history of infusion reactions to daratumumab with prior treatment that resolved with supportive measures and in whom daratumumab therapy was not previously discontinued because of infusion reactions are permitted

Subject has uncontrolled human immunodeficiency virus (HIV-1), chronic or active hepatitis B, or active hepatitis A or C

Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended

Subject has any one of the following:

Clinically significant abnormal electrocardiogram (ECG) finding at screening

Congestive heart failure (New York Heart Association class III or IV)

Myocardial infarction within 12 months prior to starting study treatment

Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris

Subject has presence of other active malignancy \[see exceptions below\] (However, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible). The following malignancies are exceptions to the active malignancy statement:

Basal cell carcinoma of the skin

Squamous cell carcinoma of the skin

Non-muscle invasive bladder cancer

Carcinoma in situ of the cervix

Carcinoma in situ of the breast

Incidental histologic finding of prostate cancer (T1a or T1b using the TNM clinical staging system) or prostate cancer that is curative

Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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 Duarte?

Yes, this clinical trial (NCT05363111) has an active research site in Duarte, CA 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.

Recurrent Plasma Cell Myeloma Treatment Options in Duarte, CA

If you're searching for recurrent plasma cell myeloma treatment options in Duarte, CA, this clinical trial (NCT05363111) 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 Duarte research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent plasma cell 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 recurrent plasma cell myeloma clinical trials near you to find additional studies recruiting in your area.

Recurrent Plasma Cell Myeloma Clinical Trial in Duarte, CA

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