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

Overview

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.

SparkCures ID 1136
Trial Phase Phase 1
Enrollment 25 Patients
Treatments
Trial Sponsors
  • Fred Hutchinson / University of Washington Cancer Consortium
Trial Collaborators
  • National Cancer Institute (NCI)
NCT Identifier

NCT04466475

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

Inclusion Criteria:

  • Patients with a diagnosis of multiple myeloma
  • Patients must have demonstrated at least a partial response (PR) according to the International Myeloma Working Group (IMWG) criteria to at least one induction regimen
  • Patients must have autologous hematopoietic stem cells collected with a minimum CD34+ stem cell yield of 8 x 10^6 CD34+ cells/kg of body weight (sufficient for two autologous hematopoietic cell transplantations [HCTs])
  • Patients must have an estimated creatinine clearance greater than 60 ml per minute by Cockcroft-Gault formula. Serum creatinine value must be within 28 +/- 2 days prior to registration
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) score =< 2 or Karnofsky score >= 70%
  • Patients must have history of CD38+ myeloma cells as demonstrated by either flow cytometry or immunohistochemistry
  • For patients of childbearing potential, must have a negative urinary pregnancy test on the day of infusion of 211At-OKT10-B10
  • Ability to provide informed consent

Exclusion Criteria:

 

  • Patients 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
  • Patients 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)
  • Patients with symptomatic coronary artery disease or uncontrolled arrhythmia
  • 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
  • Patients 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 men and women unwilling to use contraceptives during and for 12 months post-transplant
  • Patients with untreated and uncontrolled infection at time of enrollment
  • Patients 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 3 months of anticipated date of infusion of 211At-OKT10-B10

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Patients with a diagnosis of multiple myeloma
  • Patients must have demonstrated at least a partial response (PR) according to the International Myeloma Working Group (IMWG) criteria to at least one induction regimen
  • Patients must have autologous hematopoietic stem cells collected with a minimum CD34+ stem cell yield of 8 x 10^6 CD34+ cells/kg of body weight (sufficient for two autologous hematopoietic cell transplantations [HCTs])
  • Patients must have an estimated creatinine clearance greater than 60 ml per minute by Cockcroft-Gault formula. Serum creatinine value must be within 28 +/- 2 days prior to registration
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) score =< 2 or Karnofsky score >= 70%
  • Patients must have history of CD38+ myeloma cells as demonstrated by either flow cytometry or immunohistochemistry
  • For patients of childbearing potential, must have a negative urinary pregnancy test on the day of infusion of 211At-OKT10-B10
  • Ability to provide informed consent

Exclusion Criteria:

 

  • Patients 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
  • Patients 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)
  • Patients with symptomatic coronary artery disease or uncontrolled arrhythmia
  • 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
  • Patients 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 men and women unwilling to use contraceptives during and for 12 months post-transplant
  • Patients with untreated and uncontrolled infection at time of enrollment
  • Patients 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 3 months of anticipated date of infusion of 211At-OKT10-B10

US Trial Locations

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Washington

Resources

There are no resources, links or videos to display for this clinical trial.

Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message