Multiple MyelomaPhase 2NCT04635189
Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
A Phase 2 study testing Daratumumab, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Daratumumab, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2021to 8 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Phase II Study of Steroid Sparing Treatment With Daratumumab and Lenalidomide in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.
Read the detailed description
This is an open label, phase 2 study consisting of daratumumab, lenalidomide and dexamethasone, given upfront in newly diagnosed, transplant ineligible patients with myeloma. Patients participating in the study will be recruited from the Wilmot Cancer Institute, University of Rochester in Rochester, New York and all University of Rochester community affiliates.
Patients will be treated with 1800 milligrams of Daratumumab subcutaneously or 16 milligrams/kilograms daratumumab intravenously (IV) weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks. Patients will be treated with 25 milligrams of Lenalidomide days 1-21 out of a 28 day cycle (dose adjustments for creatinine clearance) and 20 milligrams of Dexamethasone at least 60 minutes prior to first infusion of daratumumab. Each cycle consists of 28 days (4 weeks).
Response assessments by International Myeloma Working Group criteria for myeloma will be performed every 4 weeks while on therapy.
- Conditions
- Multiple Myeloma
- Being tested
- Daratumumab, Lenalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Also called Darzalex
Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
LenalidomideDrug
Also called Revlimid
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
DexamethasoneDrug
Also called Ozurdex
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: Cycle 1-4 All subjects | Active comparator | 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 Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone |
| Experimental Arm: Cycle 5+ Partial Response or Better | Experimental | 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 Receives: Drug: Daratumumab; Drug: Lenalidomide |
| Experimental Arm: Cycle 5+ Less than Partial Response | Active comparator | 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 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 Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daratumumab Related Infusion Reactions
To determine the rate of daratumumab related infusion reactions in patients treated for myeloma without steroids compared to historical controls.
Measured: 28 days
Secondary outcomes (1)
Determination of Response Rates
To determine the proportion of patients who do not achieve at least a partial response after 4 cycles and require steroids to be added back to their regimen
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start27 Jul 2021
- Primary completion8 Sep 2027 (estimated)
- Study completion8 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Passero, University of Rochester
- Investigators
- Frank Passero, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635189
- Sponsor's protocol ID
- UMMY20033
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2020
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected during the trial will be shared after deidentification, including dictionaries.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Steroid Sparing Treatment With Daratumumab and Lenalidomide in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04635189
- Acronym / sponsor ID
- UMMY20033
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 8 Sep 2027 (estimated)
- Study completion
- 8 Sep 2027 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.
Detailed description
This is an open label, phase 2 study consisting of daratumumab, lenalidomide and dexamethasone, given upfront in newly diagnosed, transplant ineligible patients with myeloma. Patients participating in the study will be recruited from the Wilmot Cancer Institute, University of Rochester in Rochester, New York and all University of Rochester community affiliates.
Patients will be treated with 1800 milligrams of Daratumumab subcutaneously or 16 milligrams/kilograms daratumumab intravenously (IV) weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks. Patients will be treated with 25 milligrams of Lenalidomide days 1-21 out of a 28 day cycle (dose adjustments for creatinine clearance) and 20 milligrams of Dexamethasone at least 60 minutes prior to first infusion of daratumumab. Each cycle consists of 28 days (4 weeks).
Response assessments by International Myeloma Working Group criteria for myeloma will be performed every 4 weeks while on therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Cycle 1-4 All subjects | Active comparator | Drug: Daratumumab, Drug: Lenalidomide, Drug: DexamethasoneSubjects 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 |
| Experimental Arm: Cycle 5+ Partial Response or Better | Experimental | Drug: Daratumumab, Drug: LenalidomideSubjects 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 |
| Experimental Arm: Cycle 5+ Less than Partial Response | Active comparator | Drug: Daratumumab, Drug: Lenalidomide, Drug: DexamethasoneSubjects 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 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaratumumabAlso: DarzalexDaratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks | Drug | Experimental Arm: Cycle 1-4 All subjects, Experimental Arm: Cycle 5+ Less than Partial Response, Experimental Arm: Cycle 5+ Partial Response or Better |
| LenalidomideAlso: RevlimidLenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle | Drug | Experimental Arm: Cycle 1-4 All subjects, Experimental Arm: Cycle 5+ Less than Partial Response, Experimental Arm: Cycle 5+ Partial Response or Better |
| DexamethasoneAlso: OzurdexDexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab | Drug | Experimental Arm: Cycle 1-4 All subjects, Experimental Arm: Cycle 5+ Less than Partial Response |
Primary outcome
Daratumumab Related Infusion Reactions
Time frame: 28 days
To determine the rate of daratumumab related infusion reactions in patients treated for myeloma without steroids compared to historical controls.
1 secondary outcome
Determination of Response Rates
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the trial will be shared after deidentification, including dictionaries.
Related trials for Multiple Myeloma
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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Passero, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daratumumab, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daratumumab Related Infusion Reactions (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.