Clinical trial · Interventional
Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
A Phase II Study of Steroid Sparing Treatment With Daratumumab and Lenalidomide in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
NCT04635189CI-TRIAL-00093338active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.
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 |
|---|---|---|---|
| Daratumumab | Drug | Daratumumab | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Experimental Arm: Cycle 1-4 All subjects
- description
- Subjects will be treated with the following: * Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks * Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle * Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
- interventionNames
- Drug: Daratumumab
- Drug: Lenalidomide
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Experimental Arm: Cycle 5+ Partial Response or Better
- description
- Subjects will be treated the following: * Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks * Lenalidomide 25 milligrams/kilograms daily days 1-21 out of a 28 day cycle
- interventionNames
- Drug: Daratumumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of multiple myeloma with diagnosis * Must not have received previous therapy for multiple myeloma * Newly diagnosed and not considered candidate for high-dose chemotherapy * Adequate organ system function * A performance status ≤ 3 * Ability to swallow and retain oral medication * Female subjects of child bearing potential must be surgically sterile, be post-menopausal Exclusion Criteria: * A diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined significance, smoldering multiple myeloma; non-secretory myeloma * A diagnosis of Waldenström's disease * Receiving cancer therapy * Radiation therapy within 14 days of enrollment * Major surgery within 2 weeks before enrollment * Human immunodeficiency virus -infected patients must be on effective anti-retroviral therapy with undetectable viral load within the past 6 months * Seropositive for hepatitis B, or seropositive for hepatitis C * Ongoing systemic bacterial, fungal or viral infection * Severe and/or uncontrolled medical conditions * Malignancy within 2 years of study enrollment * Women who are pregnant or lactating * Contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism.
References
Publications (0)
Data not yet available
No reference posted for this study.