Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Actinium Ac 225-DOTA-Daratumumab
Biological/VaccineGiven IV
Daratumumab
Biological/VaccineGiven IV
Indium In 111-DOTA-Daratumumab
Biological/VaccineGiven IV
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Treatment (daratumumab, 225Ac/111In-DOTA-daratumumab)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Incidence of dose-limiting toxicities (DLTs)
Toxicity will be graded according to the National Cancer Institute (NCI)- Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
During the first 6 weeks post administration of study drug2
Maximum tolerated dose (MTD)
Toxicity will be graded according to the NCI-CTCAE version 5.0. The MTD is defined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. The MTD will be based on the assessment of DLT during the first 6 weeks.
Time frame
During the first 6 weeks post administration of study drugSecondary outcomes
1
Overall response rate
Will be defined as the proportion of patients meeting the criteria for partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR). Disease response will be evaluated per International Myeloma Working Group (IMWG) response criteria.
Time frame
Up to 12 months2
Complete response rate
Will be defined as the proportion of patients meeting the criteria for CR or sCR.
Time frame
Up to 12 months3
12-month overall survival
If a patient is still alive, survival time is censored at the time of last follow-up.
Time frame
Time from first day of treatment to time of death due to any cause, assessed up to 12 months4
Progression free survival
If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Patients who start a new treatment regimen without documented progression will be censored.
Time frame
Time from first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov