Clinical trial · Interventional
Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor no longer providing drug
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Elotuzumab | Drug | Elotuzumab | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: Elotuzumab + Lenalidomide at 25 mg
- description
- 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.
- interventionNames
- Drug: Elotuzumab
- Drug: Lenalidomide
- Drug: Dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- B: Elotuzumab + Lenalidomide at 10 mg
- description
- 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.
- interventionNames
- Drug: Elotuzumab
- Drug: Lenalidomide
- Drug: Dexamethasone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Hypercalcemia (\>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)
References
Publications (0)
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