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Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT03622775
Recruitment Status : Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if daratumumab can help to prevent multiple myeloma (MM) from coming back after patients have had an autologous stem cell transplant (ASCT). The safety of this drug after transplant will also be studied.

This is an investigational study. Daratumumab is FDA approved and commercially available for the treatment of MM. Its use after an ASCT is investigational.

The study doctor can explain how the study drug is designed to work.

Up to 56 participants will be enrolled in this study. All will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
Recurrent Plasma Cell Myeloma Biological: Daratumumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Daratumumab for Maintenance in Patients With Relapsed Multiple Myeloma After Salvage Autologous Stem Cell Transplantation
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arm Intervention/treatment
Experimental: Treatment (daratumumab)
Beginning 60-120 days after transplant, participants receive daratumumab IV over 4-8 hours on days 1, 8, 15 and 22 of courses 1 and 2 and days 1 and 15 of courses 3-6, then on day 1 of subsequent courses. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Biological: Daratumumab
Given IV
Other Names:
  • Anti-CD38 Monoclonal Antibody
  • Darzalex
  • HuMax-CD38
  • JNJ-54767414




Primary Outcome Measures :
  1. Complete remission rate (CRR) [ Time Frame: 6 months after daratumumab maintenance therapy ]
    CRR determined by the International Myeloma Working Group (IMWG).

  2. Progression-free survival (PFS) [ Time Frame: From the date of initiation of maintenance therapy assessed up to 2 years ]
    Progression-free survival defined as the interval from the date of initiation of maintenance therapy after salvage ASCT to the earlier of the first documentation of objective disease progression or death from any cause.


Other Outcome Measures:
  1. Biomarker analysis in the peripheral blood lymphocyte subsets [ Time Frame: Baseline, 1 week after the first dose, 3 months after, and until relapse up to 2 years ]
    Paired t-test, Mantel-Haenszel (MH) test and generalized linear model may be used to evaluate the changes of those biomarkers.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must have had relapsed disease prior to transplant, or undergone previous ASCT, followed by relapse and at least a partial response to salvage therapy.
  2. Male or female patients 18 years or older.
  3. Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2.
  4. Patients' clinical laboratory values and toxicity must be as specified below within 5 days before the first dose of the study drug: Platelet count >= 50,000/mm3; Absolute neutrophil count >= 1000/ mm3 (no growth factors within 5 days); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 x ULN; Creatinine <= 2.5 mg/dL; Recovered (i.e., <= grade 1 toxicity) from the reversible effects of autologous stem cell transplant.
  5. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care must be obtained, with the understanding that consent may be withdrawn by the subject at any time without any prejudice to future medical care.
  6. Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias.

Exclusion Criteria:

  1. Major surgery within 14 days before the first dose of study drug.
  2. Radiotherapy within 14 days before enrollment.
  3. Non-secretory disease, plasma cell leukemia, or previous allogeneic transplant.
  4. Already achieved CR at time of enrollment.
  5. Known active central nervous system involvement.
  6. Inability or unwillingness to comply with the drug administration requirements.
  7. Female subject is pregnant or lactating.
  8. Known active hepatitis B virus infection or known active hepatitis C virus infection.
  9. Known severe chronic obstructive pulmonary disease or asthma defined as forced expiratory volume in 1 second (FEV1) less than 60% of expected.
  10. Infection requiring IV systemic antibiotic therapy within 7 days before Cycle 1 Day 1 of therapy.
  11. Known allergy to any of the study medications, their analogues, or excipients in the various formulations.
  12. Failure to have fully recovered (i.e., </= grade 1 toxicity) from the effects of prior chemotherapy regardless of the interval since last treatment.
  13. Co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  14. If patient was unable to tolerate daratumumab in the past.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622775


Contacts
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Contact: Muzaffar Qazilbash 713-792-8750 mqazilba@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: H.       mqazilba@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Muzaffar Qazilbash M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03622775     History of Changes
Other Study ID Numbers: 2016-0681
NCI-2018-01432 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0681 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Daratumumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs