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New treatment option for Recurrent Plasma Cell Myeloma
Official title Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT05363111
What this study is testing
What is Actinium Ac 225-DOTA-Daratumumab?
Actinium Ac 225-DOTA-Daratumumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for recurrent plasma cell myeloma.
Also referred to as 225Ac-DOTA-Daratumumab; [225Ac]-DOTA-Daratumumab.
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 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.
- 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
You may be able to join if
- 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:
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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 =\ = 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 people participating in clinical studies...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, 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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, 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.