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Monoclonal Antibodies

Radioimmunotherapy + Chemotherapy Before Stem Cell Transplant for Multiple Myeloma

Phase 1
Waitlist Available
Led By Damian J. Green
Research Sponsored by Fred Hutchinson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a diagnosis of multiple myeloma
Subjects must have disease meeting criteria for clinical relapse or progressive disease (International Myeloma Working Group [IMWG] consensus criteria) and a history of >= 1 prior autologous stem cell transplant(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from response (pr or better) to disease relapse or death, assessed up to 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines a targeted radioimmunotherapy drug with chemotherapy before a stem cell transplant.

Who is the study for?
This trial is for adults with multiple myeloma who've had at least one stem cell transplant and three prior treatments including an immunomodulatory drug, a proteasome inhibitor, and a CD38-targeting antibody. They must have enough collected stem cells, no severe liver or heart issues, no HIV or certain other conditions, and be able to consent.Check my eligibility
What is being tested?
The trial tests the safety and optimal dose of a new radioimmunotherapy drug (211At-OKT10-B10) combined with melphalan chemotherapy before undergoing another stem cell transplantation. The goal is to see if this combination better targets and kills cancer cells in patients with multiple myeloma.See study design
What are the potential side effects?
Potential side effects may include reactions related to the radioactive substance such as nausea or damage to nearby healthy tissue; typical chemo side effects like hair loss, mouth sores; increased risk of infections due to weakened immune system; fatigue; allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with multiple myeloma.
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You have a history of a specific type of disease relapse and have had at least one previous autologous stem cell transplant.
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You have already tried at least three different types of treatments: a drug that changes the immune system, a drug that stops the breakdown of proteins, and a drug that targets a specific protein on cells.
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You should be able to perform everyday activities without help, or with a little help from others.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from response (pr or better) to disease relapse or death, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from response (pr or better) to disease relapse or death, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose
Secondary outcome measures
Achievement of response
Duration of response
Overall survival
+2 more

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478
23%
Blood/Bone marrow
11%
Cardiovascular
9%
Pulmonary
7%
Gastrointestinal
7%
Hepatic
5%
Graft versus host disease with infection and organ failure
2%
Dermatology/Skin
2%
respiratory failure
2%
Hemorrhage
2%
subdural hematoma
2%
thrombosis
2%
Renal/Genitourinary
2%
Metabolic/Laboratory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (TBI, Transplant, GVHD Prophylaxis)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (211At-OKT10-B10, melphalan, PBSC transplantation)Experimental Treatment3 Interventions
Patients receive 211At-OKT10-B10 IV continuously on day -10 to day - 4 (approximately day -7) and melphalan via infusion on day -2. Patients then undergo HCT on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
2008
Completed Phase 3
~1500
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor
555 Previous Clinical Trials
1,334,726 Total Patients Enrolled
66 Trials studying Multiple Myeloma
3,795 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,646 Total Patients Enrolled
572 Trials studying Multiple Myeloma
187,985 Patients Enrolled for Multiple Myeloma
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,682 Total Patients Enrolled
16 Trials studying Multiple Myeloma
936 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential risks associated with Peripheral Blood Stem Cell Transplantation?

"There is a limited amount of evidence for the efficacy and safety of Peripheral Blood Stem Cell Transplantation, thus it was given a rating of 1."

Answered by AI

What other research has taken place concerning Peripheral Blood Stem Cell Transplantation?

"At present, 32 trials are being conducted in relation to Peripheral Blood Stem Cell Transplantation. Of these active research programs, 3 are of Phase 3 status. Though the majority of such studies tare based out of Duarte California, there exist 886 sites hosting similar experiments across the US."

Answered by AI

What is the scope of participants in this research study?

"Affirmative. According to clinicaltrials.gov, this study is actively looking for enrollees. It was first posted on December 1st 2022 and has since been updated as recenty as November 1st 2022. A total of 24 participants are needed at a single medical centre."

Answered by AI

Are recruitments currently ongoing for this experiment?

"According to the clinicaltrials.gov information, this trial is actively searching for participants with its initiation dated December 1st 2022 and most recent update on November 1st 2022."

Answered by AI

To what ailments is Peripheral Blood Stem Cell Transplantation typically administered?

"Peripheral Blood Stem Cell Transplantation is an efficacious treatment for malignant effusion, mycosis fungoides (mf), and chronic lymphocytic leukemia (CLL)."

Answered by AI
~0 spots leftby Oct 2025