Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant
Status: | Not yet recruiting |
---|---|
Conditions: | Hematology, Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/3/2018 |
Start Date: | January 2019 |
End Date: | March 15, 2020 |
Contact: | Muzaffar Qazilbash |
Email: | mqazilba@mdanderson.org |
Phone: | 713-792-8750 |
Daratumumab for Maintenance in Patients With Relapsed Multiple Myeloma After Salvage Autologous Stem Cell Transplantation
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.
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.
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.
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Muzaffar H. Qazilbash
Phone: 713-792-8750
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