Treatment (daratumumab, 225Ac/111In-DOTA-daratumumab) for Refractory Plasma Cell Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CA
Refractory Plasma Cell Myeloma+3 More
Daratumumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Refractory Plasma Cell Myeloma
  • Recurrent Plasma Cell Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Refractory Plasma Cell Myeloma

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 12 months

Week 6
Incidence of dose-limiting toxicities (DLTs)
Maximum tolerated dose (MTD)
Month 12
Duration of response
Month 12
Progression free survival
Month 12
Time to progression
Month 12
12-month overall survival
Up to 12 months
Complete response rate
Overall response rate

Trial Safety

Safety Progress

1 of 3

Other trials for Refractory Plasma Cell Myeloma

Trial Design

1 Treatment Group

Treatment (daratumumab, 225Ac/111In-DOTA-daratumumab)
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (daratumumab, 225Ac/111In-DOTA-daratumumab) · No Placebo Group · Phase 1

Treatment (daratumumab, 225Ac/111In-DOTA-daratumumab)Experimental Group · 3 Interventions: Daratumumab, Indium In 111-DOTA-Daratumumab, Actinium Ac 225-DOTA-Daratumumab · Intervention Types: Biological, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2016
Completed Phase 4
~1400

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
Closest Location: City of Hope Medical Center · Duarte, CA
Photo of Duarte  1Photo of Duarte  2Photo of Duarte  3
2002First Recorded Clinical Trial
7 TrialsResearching Refractory Plasma Cell Myeloma
142 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have documented informed consent of the participant and/or legally authorized representative.
You have a 24-hour urine monoclonal protein of at least 200 mg/24 hour.
You have received treatment with all of the following: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.