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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 : Recruiting
First Posted : August 9, 2018
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase II trial studies how well daratumumab works in treating participants with multiple myeloma that has come back after stem cell transplant. Immunotherapy with daratumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.

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

Detailed Description:

PRIMARY OBJECTIVES:

I. To estimate the complete remission rate (CRR) by the International Myeloma Working Group (IMWG) criteria within 9 months post salvage auto-transplant with daratumumab maintenance therapy starting approximately 3 months post salvage auto-transplant in patients with relapsed myeloma.

SECONDARY OBJECTIVES:

I. To evaluate progression-free survival (PFS).

EXPLORATORY OBJECTIVES:

I. To discover the impact of daratumumab on graft function and immune reconstitution.

OUTLINE:

Beginning 60-120 days after transplant, participants receive daratumumab intravenously (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.

After completion of study treatment, participants are followed up at 30 and 90 days, then every 4-12 weeks thereafter.


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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
Actual Study Start Date : April 11, 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) defined as achieving a negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow [ Time Frame: At course 6 of therapy ]
    The student t-test/Wilcoxon rank test and analysis of variance (ANOVA)/Kruskal-Wallis test, or chi-squared test/Fisher's exact test will be used to test associations between the response and the prognostic factors. Complete remission will be estimated along with a 95% credible interval.

  2. Progression-free survival (PFS) [ Time Frame: From the date of initiation of maintenance therapy assessed up to 2 years ]
    Will be summarized descriptively using the Kaplan-Meier method (including the median, 95% confidence interval, and survival curve). The proportion of patients alive and without disease progression at 6 months of daratumumab maintenance therapy will be summarized. The estimate will be accompanied by a two-sided exact 95% binomial confidence interval. In addition, a Cox regression analysis may be performed if demographic and clinical factors potentially affecting PFS are identified.



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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:

  • Patient must have had relapsed disease prior to transplant, or undergone previous autologous stem cell transplant (ASCT), followed by relapse and at least a partial response to salvage therapy
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
  • Platelet count >= 50,000/mm^3 (within 5 days before the first dose of the study drug)
  • Absolute neutrophil count >= 1000/ mm^3 (no growth factors within 5 days) (within 5 days before the first dose of the study drug)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN) (within 5 days before the first dose of the study drug)
  • Creatinine =< 2.5 mg/dL (within 5 days before the first dose of the study drug)
  • Recovered (i.e., =< grade 2 toxicity) from the reversible effects of autologous stem cell transplant (within 5 days before the first dose of the study drug)
  • 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
  • Left ventricular ejection fraction >= 40%. No uncontrolled arrhythmias

Exclusion Criteria:

  • Major surgery within 14 days before the first dose of study drug
  • Radiotherapy within 14 days before enrollment
  • Non-secretory disease, plasma cell leukemia, or previous allogeneic transplant
  • Already achieved CR at time of enrollment
  • Known active central nervous system involvement
  • Inability or unwillingness to comply with the drug administration requirements
  • Female subject is pregnant or lactating
  • Seropositive for human immunodeficiency virus (HIV)
  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
  • Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)
  • Known severe chronic obstructive pulmonary disease or asthma defined as forced expiratory volume in 1 second (FEV1) less than 60% of expected
  • Infection requiring IV systemic antibiotic therapy within 7 days before cycle 1 day 1 of therapy
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations
  • Failure to have fully recovered (i.e., =< grade 2 toxicity) from the effects of prior chemotherapy regardless of the interval since last treatment
  • Patient is refractory or resistant to daratumumab
  • 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
  • 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 Recruiting
Houston, Texas, United States, 77030
Contact: Muzaffar H. Qazilbash    713-792-8750      
Principal Investigator: Muzaffar H. Qazilbash         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Muzaffar H 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: May 9, 2019
Last Verified: May 2019

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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
Daratumumab
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
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs