Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02420860
Recruitment Status : Active, not recruiting
First Posted : April 20, 2015
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE April 15, 2015
First Posted Date  ICMJE April 20, 2015
Last Update Posted Date March 18, 2019
Actual Study Start Date  ICMJE April 14, 2015
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
Progression free survival [ Time Frame: The time from autologous stem cell transplantation to the time of clinical progression, death, whichever occurs first or the time of last contact, assessed up to 48 months ]
Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be used to include multiple covariates in the time-to-event analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2015)
Progression Free Survival (PFS) [ Time Frame: Every 6 months ]
Primary endpoint is PFS defined as time from autologous stem cell transplantation (ASCT) to the time of clinical progression, death, whichever occurs first or the time of last contact. PFS monitored using the method of Thall et al. (Thall, 2005)
Change History Complete list of historical versions of study NCT02420860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
  • Response rate [ Time Frame: Up to 48 months ]
    Estimated along with 95% confidence intervals.
  • Incidence of new primary malignancy [ Time Frame: Up to 48 months ]
    Estimated along with 95% confidence intervals.
  • Overall survival [ Time Frame: Up to 48 months ]
    Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be used to include multiple covariates in the time-to-event analysis.
  • Incidence of toxicity [ Time Frame: Up to 48 months ]
    Toxicity data will be summarized by frequency tables. Per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received. The intensity (severity) of adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2015)
Toxicity of Elotuzumab with Lenalidomide [ Time Frame: 28 days ]
Toxicity evaluation endpoint defined as treatment-related unmanageable toxicities, including grade 4 non-hematologic effects, or grade 4 hematologic effects that require termination of the treatment during cycle one. Toxicity rate of 30% or higher considered unacceptable.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
Official Title  ICMJE Phase II Study of the Combination of Elotuzumab With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Brief Summary This phase II trial studies how well elotuzumab works when given with lenalidomide as maintenance therapy after transplant in patients with newly diagnosed multiple myeloma who underwent transplant using their own stem cells (autologous transplant). Maintenance therapy is treatment that is given to help keep cancer from coming back after it has disappeared following the initial treatment. Immunotherapy with monoclonal antibodies, such as elotuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Adding elotuzumab to standard maintenance therapy with lenalidomide may work better in treating patients with multiple myeloma who have undergone transplant.
Detailed Description

PRIMARY OBJECTIVES:

I. Establish activity of elotuzumab and lenalidomide in the maintenance setting post autologous stem cell transplant (ASCT) in myeloma patients.

II. Progression free survival (PFS).

SECONDARY OBJECTIVES:

I. Progression free survival 2. II. Overall survival. III. Determine incidence of secondary primary malignancy. IV. Evaluate the best response rate (stringent complete response [sCR]/very good partial response [VGPR]/partial response [PR]) based on International Myeloma Working Group (IMWG) criteria.

V. Evaluate time to progression. VI. Evaluate time to next therapy. VII. Evaluate the tolerability and toxicity. VIII. Perform MD Anderson Symptom Inventory (MDASI)-Myeloma symptom evaluation.

OUTLINE:

Patients receive elotuzumab intravenously (IV) over 2-4 hours on days 1, 8, 15, and 21 of courses 1-2 and on day 1 of each subsequent course. Patients also receive lenalidomide orally (PO) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hematopoietic Cell Transplantation Recipient
  • Plasma Cell Myeloma
Intervention  ICMJE
  • Biological: Elotuzumab
    Given IV
    Other Names:
    • BMS-901608
    • Empliciti
    • HuLuc-63
    • HuLuc63
    • PDL-063
    • PDL063
  • Drug: Lenalidomide
    Given PO
    Other Names:
    • CC-5013
    • CC5013
    • CDC 501
    • Revlimid
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE Experimental: Treatment (elotuzumab, lenalidomide)
Patients receive elotuzumab IV over 2-4 hours on days 1, 8, 15, and 21 of courses 1-2 and on day 1 of each subsequent course. Patients also receive lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Biological: Elotuzumab
  • Drug: Lenalidomide
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
100
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2015)
48
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have undergone autologous stem cell transplantation, within 18 months of initiation of induction therapy for newly diagnosed myeloma
  • Time to initiation of maintenance therapy: patients may start maintenance therapy as early as 60 days post-transplant and up to 210 days post-transplant; as long as they meet the following criteria:
  • Platelet count >= 100,000/mm^3
  • Neutrophil count >= 1000/mm^3 (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
  • Patients whose primary therapy was changed due to suboptimal response or toxicity will be eligible, however no more than 2 regimens will be allowed prior to ASCT
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
  • Female patients who: are postmenopausal for at least 24 months before the screening visit, OR; are surgically sterile, OR; if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, 28 days prior to starting study drug, during study treatment and for 28 days after the last dose of study treatment, OR agree to completely abstain from heterosexual intercourse; male patients, even if surgically sterilized (i.e., status post vasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and through 28 days after the last dose of study treatment, OR; agree to completely abstain from heterosexual intercourse

Exclusion Criteria:

  • Major surgery within 14 days before the first dose of study drug
  • Radiotherapy within 14 days before enrollment
  • Known active central nervous system involvement
  • Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment
  • Female subject is pregnant or lactating
  • Known active hepatitis B virus hepatitis, or known active hepatitis C virus
  • Infection requiring systemic IV 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 1 toxicity) from the effects of prior chemotherapy regardless of the interval since last treatment
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02420860
Other Study ID Numbers  ICMJE 2014-0729
NCI-2015-00762 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0729 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Sheeba Thomas M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date March 2019

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