NCT04635189Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 12 Nov 2020
- Start date
- 27 Jul 2021
- Primary completion date
- 8 Sept 2027
- Lead sponsor
- University of Rochester
- Diseases
- Multiple myeloma
- NCT number
- NCT04635189
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 28
- From 27 Jul 2021 to the primary completion date, 8 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving cancer therapy
- Radiation therapy within 14 days of enrollment
- Major surgery within 2 weeks before enrollment
Other illness
- A diagnosis of Waldenström's disease
- 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
- Contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism.
Other
- A diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined significance, smoldering multiple myeloma; non-secretory myeloma
- Women who are pregnant or lactating
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.