MyelomaPhase 2NCT03500445
Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma
A Phase 2 study testing Daratumumab, Carfilzomib and Lenalidomide in people with Myeloma and Multiple Myeloma, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine response rate after 8 cycles of D-KRd (daratumumab, carfilzomib, lenalidomide (Revlimid) and dexamethasone in patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma, Multiple Myeloma
- What is being tested?
- Daratumumab, Carfilzomib and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed, previously untreated myeloma requiring systemic chemotherapy
- Prior treatment of hypercalcemia or spinal cord compression or active and/or aggressively progressing myeloma with corticosteroids or lenalidomide or bortezomib-based regimens does not disqualify the patient (the treatment dose should not exceed the equivalent of 160 mg of dexamethasone in a 4 week period or not more than 1 cycle of Proteasome Inhibitor / Immunomodulatory-based therapy)
- Both transplant and non-transplant candidates are eligible.
- Diagnosis of symptomatic multiple myeloma as per current International Myeloma Working Group (IMWG) uniform criteria prior to initial treatment
- Monoclonal plasma cells in the Bone Marrow (BM) ≥ 10% or presence of a biopsy-proven plasmacytoma
- Measurable disease, prior to initial treatment as indicated by one or more of the following:
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- Serum M-protein ≥ 1 g/dL
- Urine M-protein ≥ 200 mg/24 hours
- If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable
- Serum freelite measurable disease as per current IMWG criteria
- Bone marrow specimen will be required at study entry; available DNA sample from pre-induction BM will be used for calibration step for MRD evaluation by gene sequencing.
- Males and females ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate hepatic function, with bilirubin ≤ 1.5 x upper limit of normal (ULN) and aspirate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN
- Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L, hemoglobin ≥ 8 g/dL, platelet count ≥ 75 x 109/L.
- Calculated creatinine clearance (by Cockroft-Gault) ≥ 50 mL/min or serum creatinine below 2 g/dL
- Woman of childbearing potential must have 2 negative pregnancy tests prior to initiating lenalidomide.
- Woman of childbearing potential must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study; and 3) for at least 30 days after discontinuation from the study.
- Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 90 days following discontinuation from the study even if he has undergone a successful vasectomy.
- All study participants in the US must be consented to and registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS®) program and be willing and able to comply with the requirements of Revlimid REMS®.
- Voluntary written informed consent.
Who cannot join
- Frail non-transplant candidates, defined as in Palumbo et al, Blood 2015.
- Non-secretory or hyposecretory multiple myeloma, prior to initial treatment defined as <1.0 g/dL M-protein in serum, <200 mg/24 hr urine M-protein, and no measurable disease as per IMWG by Freelite.
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Amyloidosis
- Plasma cell leukemia
- Waldenström's macroglobulinemia or Immunoglobulin M-producing (IgM) myeloma
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- Radiotherapy to multiple sites or immunotherapy within 4 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
- Participation in an investigational therapeutic study within 3 weeks or within 5 drug half-lives (t1/2) prior to first dose, whichever time is greater
- Potential subjects with evidence of progressive disease as per IMWG criteria
- Patients not able to tolerate daratumumab, carfilzomib, lenalidomide or dexamethasone
- Peripheral neuropathy ≥ Grade 2 at screening
- Diarrhea > Grade 1 in the absence of antidiarrheals
- Central Nervous System (CNS) involvement
- Pregnant or lactating females
- Major surgery within 3 weeks prior to first dose.
- Myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Prior or concurrent pulmonary embolism
- Known moderate or severe persistent asthma or known chronic obstructive pulmonary disease (COPD)
- Known or suspected chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal
- Moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification. Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study.
- Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12-lead ECG during screening
- Uncontrolled hypertension or diabetes
- Acute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- Non-hematologic malignancy or non-myeloma hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < Gleason Grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone
- Any clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Single-arm, Phase 2 Study of Initial Treatment With Daratumumab (Darzalex), Carfilzomib (Kyprolis), Lenalidomide (Revlimid) and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma Requiring Systemic Chemotherapy
The purpose of this study is to determine response rate after 8 cycles of D-KRd (daratumumab, carfilzomib, lenalidomide (Revlimid) and dexamethasone in patients with multiple myeloma.
- Conditions
- Myeloma, Multiple Myeloma
- Being tested
- Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone
- Medical subject headings
- Neoplasms, Plasma Cell, 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 mg/kg) will be administered as an IV infusion:
- Cycle 1-2: 16 mg/kg weekly
- Cycles 3-8: 16 mg/kg IV infusion every 2 weeks
- Cycles 9-24: 16 mg/kg IV infusion Day 1
CarfilzomibDrug
Also called KYPROLIS®
Carfilzomib will be given as an IV infusion over 30 minutes:
- Cycle 1: 20 mg/m2 Days 1, 2; 36 mg/m2 Days 8, 9, 15, 16. Alternatively, intermediate dose escalation (to 27mg/m2 on days 8, 9 of cycle 1) will be allowed at the treating physician's discretion.
- Cycle 2-9: 36 mg/m2 (or best tolerated dose) Days 1, 2, 8, 9, 15 and 16
- Cycles 9-24: 36 mg/m2 (or best tolerated dose) Days 1, 2, 15 and 16
LenalidomideDrug
Also called REVLIMID®
Lenalidomide will be taken orally as follows:
- Cycles 1-24: 25 mg (or best tolerated dose) PO Days 1-21
DexamethasoneDrug
Dexamethasone will be administered prior to carfilzomib (on days that they coincide), as follows:
- Cycles 1-9: 40 mg PO (subjects ≤ 75 years) or 20 mg PO (subjects ≥ 75 years) per week
- Cycles 9-24: 20 mg PO per week
During weeks when daratumumab is given: 40 mg dexamethasone weekly, 20 mg prior to daratumumab infusion and 20 mg PO the day after
During weeks with no daratumumab, single dose of 20 mg on day 1
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm (D-KRd) | Experimental | Not described Receives: Drug: Daratumumab; Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of stringent complete response (sCR)
Measured: 8 months
Rate of minimal residual disease (MRD)-negative disease as assessed by Next Generation Sequencing
Measured: 8 months
Secondary outcomes (7)
Long term rate of MRD-negative disease
Measured: 2 years
Duration of response
Measured: 1 year
Rate of progression free survival
Measured: 2 years
Time to progression
Measured: 2 years
Overall survival rate
Measured: 2 years
Overall response rate
Measured: 2 years
Number of grade 2 or higher side effects as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 criteria
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start13 Feb 2019
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Amgen
- Responsible party
- Sponsor
- Investigators
- Benjamin Derman, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500445
- Sponsor's protocol ID
- IRB17-1097
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2018
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-arm, Phase 2 Study of Initial Treatment With Daratumumab (Darzalex), Carfilzomib (Kyprolis), Lenalidomide (Revlimid) and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma Requiring Systemic Chemotherapy
- ClinicalTrials.gov ID
- NCT03500445
- Acronym / sponsor ID
- IRB17-1097
- Conditions
- Myeloma, Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Amgen
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 18 Apr 2018 (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 response rate after 8 cycles of D-KRd (daratumumab, carfilzomib, lenalidomide (Revlimid) and dexamethasone in patients with multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm (D-KRd) | Experimental | Drug: Daratumumab, Drug: Carfilzomib, Drug: Lenalidomide, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Newly diagnosed, previously untreated myeloma requiring systemic chemotherapy
- Both transplant and non-transplant candidates are eligible.
- Diagnosis of symptomatic multiple myeloma as per current International Myeloma Working Group (IMWG) uniform criteria prior to initial treatment
- Monoclonal plasma cells in the Bone Marrow (BM) ≥ 10% or presence of a biopsy-proven plasmacytoma
- Measurable disease, prior to initial treatment as indicated by one or more of the following:
Key exclusion criteria (26 listed)
- Frail non-transplant candidates, defined as in Palumbo et al, Blood 2015.
- Non-secretory or hyposecretory multiple myeloma, prior to initial treatment defined as <1.0 g/dL M-protein in serum, <200 mg/24 hr urine M-protein, and no measurable disease as per IMWG by Freelite.
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Amyloidosis
- Plasma cell leukemia
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: DARZALEX®Daratumumab (16 mg/kg) will be administered as an IV infusion: * Cycle 1-2: 16 mg/kg weekly * Cycles 3-8: 16 mg/kg IV infusion every 2 weeks * Cycles 9-24: 16 mg/kg IV infusion Day 1 | Drug | Treatment Arm (D-KRd) |
| CarfilzomibAlso: KYPROLIS®Carfilzomib will be given as an IV infusion over 30 minutes: * Cycle 1: 20 mg/m2 Days 1, 2; 36 mg/m2 Days 8, 9, 15, 16. Alternatively, intermediate dose escalation (to 27mg/m2 on days 8, 9 of cycle 1) will be allowed at the treating physician's discretion. * Cycle 2-9: 36 mg/m2 (or best tolerated dose) Days 1, 2, 8, 9, 15 and 16 * Cycles 9-24: 36 mg/m2 (or best tolerated dose) Days 1, 2, 15 and 16 | Drug | Treatment Arm (D-KRd) |
| LenalidomideAlso: REVLIMID®Lenalidomide will be taken orally as follows: • Cycles 1-24: 25 mg (or best tolerated dose) PO Days 1-21 | Drug | Treatment Arm (D-KRd) |
| DexamethasoneDexamethasone will be administered prior to carfilzomib (on days that they coincide), as follows: * Cycles 1-9: 40 mg PO (subjects ≤ 75 years) or 20 mg PO (subjects ≥ 75 years) per week * Cycles 9-24: 20 mg PO per week During weeks when daratumumab is given: 40 mg dexamethasone weekly, 20 mg prior to daratumumab infusion and 20 mg PO the day after During weeks with no daratumumab, single dose of 20 mg on day 1 | Drug | Treatment Arm (D-KRd) |
Primary outcome
Rate of stringent complete response (sCR)
Time frame: 8 months
Rate of minimal residual disease (MRD)-negative disease as assessed by Next Generation Sequencing
Time frame: 8 months
7 secondary outcomes
Long term rate of MRD-negative disease
Time frame: 2 years
Duration of response
Time frame: 1 year
Rate of progression free survival
Time frame: 2 years
Time to progression
Time frame: 2 years
Overall survival rate
Time frame: 2 years
Overall response rate
Time frame: 2 years
Number of grade 2 or higher side effects as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 criteria
Time frame: 8 months
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 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Benjamin Derman, MD principal investigator
University of Chicago
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, Carfilzomib and Lenalidomide in people with Myeloma and Multiple Myeloma, run by University of Chicago 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 21 inclusion and 26 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 13 Apr 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?
Rate of stringent complete response (sCR) (time frame: 8 months). The study lists 2 primary outcomes in all. 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 13 Apr 2026.