Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide

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.
ClinicalTrials.gov Identifier: NCT03411031
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:
The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma participants with serologic relapse/progression while receiving lenalidomide maintenance for each study arm.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Elotuzumab Drug: Lenalidomide Drug: Dexamethasone Phase 2

Detailed Description:

This is a randomized parallel 2-cohort phase 2 study of elotuzumab given at 10 mg/kg weekly during induction in combination with lenalidomide (either 25 mg or 10 mg) in patients with multiple myeloma who progress or relapse serologically while on single agent lenalidomide maintenance.

The combination therapy with elotuzumab and lenalidomide will be continued until further progression of myeloma (based on response criteria) or intolerability.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Parallel Phase 2 Study of Elotuzumab Plus Lenalidomide (Elo/Rev) for the Treatment of Serologic Relapse/Progression While on Lenalidomide Maintenance for Multiple Myeloma
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
Active Comparator: A: Elotuzumab + Lenalidomide at 25 mg

Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.

Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.

Drug: Elotuzumab
Elotuzumab according to dosing schedule outlined in treatment arms.
Other Names:
  • Empliciti™
  • BMS-901608
  • HuLuc63

Drug: Lenalidomide
Lenalidomide according to dosing schedule outlined in treatment arms.
Other Names:
  • REVLIMID®
  • thalidomide analogue

Drug: Dexamethasone

Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.

During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.

Other Name: Decadron

Active Comparator: B: Elotuzumab + Lenalidomide at 10 mg

Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.

Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.

Drug: Elotuzumab
Elotuzumab according to dosing schedule outlined in treatment arms.
Other Names:
  • Empliciti™
  • BMS-901608
  • HuLuc63

Drug: Lenalidomide
Lenalidomide according to dosing schedule outlined in treatment arms.
Other Names:
  • REVLIMID®
  • thalidomide analogue

Drug: Dexamethasone

Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.

During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.

Other Name: Decadron




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 12 months post last participant enrollment date ]
    Progression free survival (PFS) is defined as the time of randomization to date of death from any cause, date of relapse/progression, or the last follow-up date, whichever comes first. The Kaplan-Meier method will be used to estimate PFS for each Study Arm. The method of Brookmeyer and Crowley will be used to construct 95% confidence interval.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 60 days post last study treatment ]
    Overall response rate (ORR) with elotuzumab and lenalidomide for each study arm. The Consensus on Uniform Reporting of Response will be used to evaluate response. Myeloma participants enrolled in this clinical study will be assessed for disease response after every cycle.

  2. Minimum Response (MR) [ Time Frame: Up to 60 days post last study treatment ]
    Minimum response (MR) or better rate with elotuzumab and lenalidomide for each study arm. The Consensus on Uniform Reporting of Response will be used to evaluate response. Myeloma participants enrolled in this clinical study will be assessed for disease response after every cycle.

  3. Time to Next Treatment (TTNT) [ Time Frame: Up to 60 days post last study treatment ]
    Time to next treatment (TTNT): Median time free of treatment per study arm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients with multiple myeloma who demonstrate evidence of serologic relapse/progression while on lenalidomide maintenance given as part of first line therapy (including upfront high-dose chemotherapy followed by autologous hematopoietic cell transplantation (HCT)) without symptomatic relapse/progression. Lenalidomide maintenance is defined as single agent lenalidomide therapy of any doses up to 10 mg PO daily for up to 28 days (28-day cycle).
  • Male or female patients aged ≥ 18 years old
  • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
  • Measurable disease as outlined in protocol guidelines
  • Participants must meet laboratory criteria as outlined in protocol guidelines

Exclusion Criteria:

  • Prior elotuzumab
  • Patients with clinical relapse/progression as per the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma defined as one or more of the following criteria:

    • Development of new soft tissue plasmacytomas or bone lesions (osteoporotic fractures do not constitute progression)
    • Definite increase in the size of existing plasmacytomas or bone lesions. A definite increase is defined as a 50% (and ≥1 cm) increase as measured serially of the measurable lesion
    • Hypercalcaemia (>11 mg/dL);
    • Decrease in hemoglobin of ≥2 g/dL not related to therapy or other non-myeloma-related conditions;
    • Rise in serum creatinine by 2 mg/dL or more from the start of the therapy and attributable to myeloma
    • Hyperviscosity related to serum paraprotein
  • Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy testing within 7 days prior to the administration of drug.
  • Male patients whose sexual partners are WOCBP not using effective birth control
  • Patients with a prior malignancy with in the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)
  • Patients with known positivity for human immunodeficiency virus (HIV)) or hepatitis C; baseline testing for HIV and hepatitis C is not required
  • Patients with a diagnosis of POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)

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): NCT03411031


Locations
Layout table for location information
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Mark Melody    813-745-3420    mark.melody@moffitt.org   
Contact: Melissa Alsina, M.D.    813-745-7202    melissa.messina@moffitt.org   
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Principal Investigator: Melissa Alsina, M.D. H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03411031     History of Changes
Other Study ID Numbers: MCC-19197
NCI-2018-00891 ( Other Identifier: NCI )
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
lenalidomide maintenance
hematopoietic cell transplantation
serologic relapse

Additional relevant MeSH terms:
Layout table for MeSH terms
Lenalidomide
Multiple Myeloma
Neoplasms, Plasma Cell
Recurrence
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
Disease Attributes
Pathologic Processes
Dexamethasone
Dexamethasone acetate
Elotuzumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones