Description:
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.
Title
- Brief Title: Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
- Official Title: Phase II Study of the Combination of Elotuzumab With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID:
2014-0729
- SECONDARY ID:
NCI-2015-00762
- SECONDARY ID:
2014-0729
- NCT ID:
NCT02420860
Conditions
- Hematopoietic Cell Transplantation Recipient
- Plasma Cell Myeloma
Interventions
Drug | Synonyms | Arms |
---|
Elotuzumab | BMS-901608, Empliciti, HuLuc-63, HuLuc63, PDL-063, PDL063 | Treatment (elotuzumab, lenalidomide) |
Lenalidomide | CC-5013, CC5013, CDC 501, Revlimid | Treatment (elotuzumab, lenalidomide) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Treatment (elotuzumab, lenalidomide) | Experimental | 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. | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Response rate |
Time Frame: | Up to 48 months |
Safety Issue: | |
Description: | Estimated along with 95% confidence intervals. |
Measure: | Incidence of new primary malignancy |
Time Frame: | Up to 48 months |
Safety Issue: | |
Description: | Estimated along with 95% confidence intervals. |
Measure: | Overall survival |
Time Frame: | Up to 48 months |
Safety Issue: | |
Description: | 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. |
Measure: | Incidence of toxicity |
Time Frame: | Up to 48 months |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | M.D. Anderson Cancer Center |
Last Updated
October 22, 2020