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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

This study is currently recruiting participants.
Verified October 2017 by University of Arkansas
Sponsor:
ClinicalTrials.gov Identifier:
NCT03168100
First Posted: May 30, 2017
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Arkansas
May 24, 2017
May 30, 2017
October 6, 2017
October 1, 2017
June 2020   (Final data collection date for primary outcome measure)
Depth of Response [ Time Frame: Six months from start of study treatment. ]
Depth of response will be measured by minimal residual disease (MRD) status (i.e., positive or negative).
Same as current
Complete list of historical versions of study NCT03168100 on ClinicalTrials.gov Archive Site
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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
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).
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Elotuzumab
    administered via IV infusion
    Other Name: Empliciti
  • Drug: Lenalidomide
    taken by mouth
    Other Name: Revlimid
  • Drug: Dexamethasone
    taken by mouth
    Other Name: Decadron
  • Drug: Bortezomib
    administered as a subcutaneous injection
    Other Name: Velcade
Experimental: Study Treatment
Elotuzumab (10 mg Days 1 and 15), lenalidomide (15 mg Days 1-21), and dexamethasone (20 mg days 1, 8, 15, and 22) administered in 28-day cycles which will be alternated every 8 weeks with bortezomib (1.0 mg Days 1, 8, and 15), lenalidomide (15 mg Days 1-21), and dexamethasone (20 mg Days 1, 8, 15, and 22)
Interventions:
  • Drug: Elotuzumab
  • Drug: Lenalidomide
  • Drug: Dexamethasone
  • Drug: Bortezomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
115
July 2028
June 2020   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Nathan Petty 501-526-6990 ext 2435 pettynathanm@uams.edu
Contact: David Avery 501-526-6990 ext 2431 daavery@uams.edu
United States
 
 
NCT03168100
206603
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
Plan Description: There are no plans to share individual participant data.
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Faith Davies, MD University of Arkansas
University of Arkansas
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP