AzTrials
AzTrials

Plasma Cell MyelomaPhase 1NCT04466475

Radioimmunotherapy (211At-OKT10-B10) and Chemotherapy (Melphalan) Before Stem Cell Transplantation for the Treatment of Multiple Myeloma

A Phase 1 study testing Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10, Melphalan and Peripheral Blood Stem Cell Transplantation in people with Plasma Cell Myeloma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This phase I trial studies the side effects and best dose of 211At-OKT10-B10 when given together with melphalan before a stem cell transplantation in treating patients with multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plasma Cell Myeloma
What is being tested?
Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10, Melphalan and Peripheral Blood Stem Cell Transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
27 Jan 2024to 30 Sep 2027
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of multiple myeloma
  • Patients must have autologous hematopoietic stem cells collected with a minimum CD34+ stem cell yield of >= 4 x 10^6 CD34+ cells/kg of body weight
  • 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)
  • Subjects must have received at least 3 prior lines of therapy: an immunomodulatory drug, a proteasome inhibitor, and a CD38-targeting antibody
  • Aline of therapy is defined as one or more cycles of a planned treatment program. This may consist of one or more planned cycles of a single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. For example, a planned treatment approach of induction therapy followed by autologous stem cell transplantation, followed by maintenance is considered one line of therapy. A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a results of disease progression, relapse, or toxicity. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease
  • Subjects must have an estimated creatinine clearance greater than 60 ml per minute by the following formula (Cockcroft-Gault). Serum creatinine value must be within 28 +/- days prior to registration
Show all 9Show fewer
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) score =< 2 or Karnofsky score >= 70%
  • Ability to provide informed consent
  • Subjects 18 years of age

Who cannot join

  • Subjects with a history of plasma cell leukemia
  • History of central nervous system involvement by multiple myeloma
  • Prior radioimmunotherapy or radiation of > 20 Gy to pelvis or at maximally tolerated levels to any critical normal organ
  • Prior allogeneic hematopoietic cell transplant
  • More than 2 prior autologous hematopoietic cell transplants
  • Subjects with medullary or extramedullary plasmacytoma/s measuring > 3 cm by magnetic resonance imaging (MRI) or positron emission tomography (PET)-computed tomography (CT) (radiated lesions are exempt from this criterion)
Show all 25Show fewer
  • Subjects with a history of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease as determined by the principal investigator (PI) or designee
  • Subjects with corrected QT (QTc) prolongation at baseline
  • Subjects with a history of cardiac arrhythmia and a heart rate > 100 beats per minute (BPM) (oral beta-blocker [excluding sotalol] and/or calcium channel blocker therapy are acceptable to achieve rate control)
  • History of reactive airway disease and clinically significant asthma requiring any form of medical treatment in the prior three months
  • Left ventricular ejection fraction < 40%
  • Corrected diffusing capacity of the lungs for carbon monoxide (DLCO) < 50% or receiving supplemental continuous oxygen
  • Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease.
  • Bilirubin > 2 times the upper limit of normal
  • Aspartate aminotransferase [AST] and alanine aminotransferase [ALT] > 2 times the upper limit of normal
  • Subjects who are known to be seropositive for human immunodeficiency virus (HIV)
  • Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin [HCG]+) or breast feeding
  • Fertile subjects unwilling to use contraceptives during and for 12 months post-transplant
  • Subjects with untreated and uncontrolled infection at time of enrollment
  • Subjects with known amyloid light-chain (AL) subtype amyloidosis
  • Known allergy to murine-based monoclonal antibodies
  • Known contraindications to radiotherapy
  • History of another primary malignancy that has not been in remission for at least 2 years (the following are exempt from the 2-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou [PAP] smear)
  • Any anti-CD38 monoclonal antibody within 30 days of anticipated date of infusion of 211At-OKT10-B10
  • Individuals with a history of CTCAE grade 4 gastrointestinal toxicity associated with prior high-dose melphalan conditioning therapy (previous autologous stem cell transplant)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase I Trial Evaluating Escalating Doses of 211At-Labeled Anti-CD38 Monoclonal Antibody (211At-OKT10-B10) Combined With Melphalan as Conditioning Prior to Autologous Hematopoietic Cell Transplantation for Patients With Multiple Myeloma

This phase I trial studies the side effects and best dose of 211At-OKT10-B10 when given together with melphalan before a stem cell transplantation in treating patients with multiple myeloma. The radioimmunotherapy drug 211At-OKT10-B10 is a monoclonal antibody, called OKT10-B10, linked to a radioactive substance called 211At. OKT10-B10 attaches to CD38 positive cancer cells in a targeted way and delivers 211At to kill them. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving 211At-OKT10-B10 with melphalan before a stem cell transplant may kill more cancer cells.

Read the detailed description

OUTLINE: This is a dose-escalation study of 211At-OKT10-B10.

Patients receive 211At-OKT10-B10 intravenously (IV) continuously on day -10 to day - 4 (approximately day -7) and melphalan via infusion on day -2. Patients then undergo hematopoietic cell transplantation (HCT) on day 0.

After completion of study treatment, patients are followed for 30 days, between 80 and 90 days, at 6, 9, 12, 18, and 24 months, and then annually thereafter.

Being tested
Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10, Melphalan, Peripheral Blood Stem Cell Transplantation
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10Biological

    Also called 211At-OKT10-B10, [211At]OKT10-B10, Astatine 211-labeled Anti-CD38 Monoclonal Antibody OKT10-B10, Astatine At 211 Anti-CD38 MoAb OKT10-B10

    Given IV

  • MelphalanDrug

    Also called Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard

    Given via infusion

  • Peripheral Blood Stem Cell TransplantationProcedure or surgery

    Also called PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support

    Undergo PBSC transplantation

Study groups in NCT04466475
Study groupRoleWhat they receive
Treatment (211At-OKT10-B10, melphalan, PBSC transplantation)ExperimentalPatients 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.
Receives: Biological: Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10; Drug: Melphalan; Procedure: Peripheral Blood Stem Cell Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose

    Defined a true dose limiting toxicity (DLT) probability of 25% of subjects, where a DLT is defined as any grade 3-5 nonhematologic regimen-related toxicity within the first 30 days following autologous hematopoietic cell transplantation.

    Measured: Up to 30 days post-transplant

Secondary outcomes (5)

  1. Achievement of response

    Measured per the International Myeloma Working Group criteria. The response rates (partial response [PR] or better) will be estimated along with the exact 95% confidence interval.

    Measured: Between days +80 to +90 post-transplant

  2. Duration of response

    Duration of response will be estimated using Kaplan-Meier methodology.

    Measured: From response (PR or better) to disease relapse or death, assessed up to 5 years

  3. Overall survival

    Kaplan-Meier methodology will be used to estimate the 2-year overall survival.

    Measured: From transplantation to death, assessed up to 2 years post-transplant

  4. Progression-free survival

    Kaplan-Meier methodology will be used to estimate the 2-year progression-free survival.

    Measured: From transplantation to disease relapse or death, assessed up to 2 years post-transplant

  5. Rates of minimal residual disease (MRD)

    MRD will be assessed using multi-color flow cytometry and next generation sequencing in conjunction with functional imaging (i.e., positron emission tomography-computed tomography). The proportion who achieve MRD will be estimated along with an exact 95% confidence interval.

    Measured: At days 28, and +80 to +90 post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2020
  2. Study start27 Jan 2024 (estimated)
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Why it stopped: NIH terminated funding. Study was closed before any participants were enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04466475
Sponsor's protocol ID
RG1006317
Other IDs
NCI-2019-06979, 10306, R01CA205248
Status last verified
Sep 2023
First submitted
8 Jul 2020
Last updated
31 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10, Melphalan and Peripheral Blood Stem Cell Transplantation in people with Plasma Cell Myeloma, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: Up to 30 days post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04466475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in