2017-03: A Single-Arm, Open-label Study of Anti-Signaling Lymphocytic Activation Molecule F7 (Anti-SLAMF7) Monoclonal Antibody (mAb) Therapy After Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Status: | Withdrawn |
---|---|
Conditions: | Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/30/2019 |
Start Date: | October 1, 2017 |
End Date: | January 24, 2019 |
University of Arkansas (UARK# 2017-03): A Single-Arm, Open-label Study of Anti-SLAMF7 mAb Therapy After Autologous Stem Cell Transplant in Patients With Multiple Myeloma (Total Therapy 8)
The Total Therapy treatment regimens developed at the Myeloma Institute have demonstrated
great improvement in treatment outcomes for multiple myeloma patients. However, some patients
still relapse early during maintenance treatment meaning that better options are still
needed. This study will evaluate a treatment regimen that alternates two different 3-drug
regimens every eight weeks for patients that have previously completed autologous stem cell
transplant. The two regimens are bortezomib, lenalidomide, and dexamethasone (VRD) which will
be alternated with Elotuzumab, lenalidomide, and dexamethasone (Elo RD). Effectiveness will
be measured by the depth of response (i.e., whether or not minimal residual disease (MRD)
negative status is achieved). The rate of MRD negativity from this study will be compared to
historical control data from the Total Therapy 4 trial which used continuous VRD maintenance
therapy after stem cell transplant(s).
great improvement in treatment outcomes for multiple myeloma patients. However, some patients
still relapse early during maintenance treatment meaning that better options are still
needed. This study will evaluate a treatment regimen that alternates two different 3-drug
regimens every eight weeks for patients that have previously completed autologous stem cell
transplant. The two regimens are bortezomib, lenalidomide, and dexamethasone (VRD) which will
be alternated with Elotuzumab, lenalidomide, and dexamethasone (Elo RD). Effectiveness will
be measured by the depth of response (i.e., whether or not minimal residual disease (MRD)
negative status is achieved). The rate of MRD negativity from this study will be compared to
historical control data from the Total Therapy 4 trial which used continuous VRD maintenance
therapy after stem cell transplant(s).
Inclusion Criteria:
- Patients must be at least 18 years of age and not older than 75 years of age at the
time of enrollment.
- Patients must have completed a stem cell transplant regimen for newly diagnosed
multiple myeloma (MM) consisting of (at least) induction chemotherapy and single or
tandem autologous stem cell transplant (ASCT) within eight months of study enrollment.
The completed regimen may have included post-transplant consolidation therapy, but
post-transplant consolidation is not required.
- Patients must have achieved at least a partial response (PR) (according to
International Myeloma Working Group (IMWG) criteria) in response to the completed
transplant regimen.
- ECOG ≤ 2 (ECOG of 3 allowed if solely due to symptoms of MM-related bone disease).
- Patients must have absolute neutrophil count (ANC) ≥ 1,000/mm3 and a platelet count of
≥ 75,000/μL.
- Patients must have a baseline serum creatinine level of < 3 mg/dL and baseline alanine
aminotransferase (ALT) < 3x Upper limit of normal (ULN)
- Toxicities related to prior therapies must be resolved to ≤ Grade 2 according to NCI
Common Terminology for Adverse Events (CTCAE) Version 4.
- Female patients must be:
- Postmenopausal for at least 1 year before the screening visit, OR
- Surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 simultaneous effective
methods of contraception, from the time of signing the informed consent form
through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and
usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,
symptothermal, post-ovulation methods] and withdrawal are not acceptable methods
of contraception.)
- Male patients, even if surgically sterilized (ie, post-vasectomy) must agree to one of
the following:
- Practice effective barrier contraception during the entire study treatment period
and through 90 days after the last dose of study drug, OR
- Practice true abstinence when this is in line with the preferred and usual
lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,
symptothermal, post-ovulation methods] and withdrawal are not acceptable methods
of contraception.)
- Patients must sign an Institutional Review Board (IRB)-approved informed consent
indicating their understanding of the proposed treatment and understanding that the
protocol has been approved by the IRB.
Exclusion Criteria:
- Female patients who are nursing or pregnant may not participate. Women of childbearing
potential must have a negative pregnancy documented within one week of beginning study
treatment. Refer to the Revlimid Risk Evaluation and Mitigation Strategies (REMS)
program for more information.
- History of poorly controlled hypertension, diabetes mellitus, active or uncontrolled
hepatitis, or other serious medical or psychiatric illness that could potentially
interfere with the completion of treatment according to this protocol, or that in the
opinion of the investigator would constitute a hazard for participating in this study.
- History of clinically significant cardiac disease as determined by the enrolling
physician including cardiac amyloidosis.
- Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or other cancer for which the patient has not
received treatment for one year prior to enrollment. Other cancers will be acceptable
if the patient's life expectancy exceeds five years.
- Known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human
proteins or any of the study medications, their analogues, or excipients in the
various formulations of any agent (refer to the latest versions of the package
inserts).
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
Phone: 501-686-8274
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
Click here to add this to my saved trials