Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

DVRd in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma

Q: Who can participate in NCT06158269?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06158269?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Phase II Clinical Study of Daratumumab Combined With Bortezomib, Lenalidomide and Dexamethasone (DVRd) in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma

DVRd in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma (NCT06158269) is a Phase 2 interventional studying Multiple Myeloma, sponsored by Institute of Hematology & Blood Diseases Hospital, China. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Evaluate the efficacy of DVRd in patients with newly diagnosed double-hit multiple myeloma (MM) and the feasibility of minimal residual disease (MRD) guided maintenance therapy

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Multiple Myeloma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily signing the willing to sign a consent form Form (ICF). 2. Age: ≥ 18 years old and \< 70 years old. 3. Newly diagnosed MM according to International Myeloma Working Group (IMWG) criteria, with at least one measurable disease: The serum M protein detected by serum protein electrophoresis (SPEP) is ≥ 1g/dL (≥ 10 g/L), or if it is immunoglobulin A (IgA) or immunoglobulin D (IgD) subtype, quantitative levels of total IgA or IgD can be used as a substitute; Or urine M-protein level ≥ 200 mg/24 h; Or if only the serum free light chain (FLC) ratio is abnormal, the affected serum FLC ≥ 100 mg/L (normal FLC ratio: 0.26 to 1.65). 4. At least two high-risk cytogenetic abnormalities: t(4;14), t(14;16), t(14;20), del(17p), gain/amp(1q) (the threshold for copy number variation is 20%, and the threshold for translocation is 10%. 5. The Eastern Cooperative Oncology Group (ECOG) score is 0, 1, or 2 points. The ECOG score of 3 points due to myeloma bone disease can be included. 6. Subjects had not received any anti-MM chemotherapy, extensive pelvic irradiation (more than half of the pelvic area), or anti-MM glucocorticoids, except those who used glucocorticoids for no more than 14 days to control symptoms. 7. Total bilirubin \< 1.5 × upper limit of normal (ULN) (total bilirubin in patients with Gilbert's syndrome can be restricted to \<3 × ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. 8. Creatinine clearance rate ≥ 30 mL/min (calculated by cockcroft and Gault formulas). 9. Routine blood test within 7 days before the first day of cycle 1 meets the following criteria: white blood cell (WBC) count ≥ 1.5×10\^9/L, absolute neutrophil count ≥ 1.0×10\^9/L, blood count (hemoglobin) at least 75 g/L, and platelet count ≥ 75×10\^9/L (if bone marrow plasmacytes \< 50%) or platelet count ≥ 50×10\^9/L (if bone marrow plasmacytes ≥ 50%). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Voluntarily signing the Informed Consent Form (ICF). 2. Age: ≥ 18 years old and \< 70 years old. 3. Newly diagnosed MM according to International Myeloma Working Group (IMWG) criteria, with at least one measurable disease: The serum M protein detected by serum protein electrophoresis (SPEP) is ≥ 1g/dL (≥ 10 g/L), or if it is immunoglobulin A (IgA) or immunoglobulin D (IgD) subtype, quantitative levels of total IgA or IgD can be used as a substitute; Or urine M-protein level ≥ 200 mg/24 h; Or if only the serum free light chain (FLC) ratio is abnormal, the affected serum FLC ≥ 100 mg/L (normal FLC ratio: 0.26 to 1.65). 4. At least two high-risk cytogenetic abnormalities: t(4;14), t(14;16), t(14;20), del(17p), gain/amp(1q) (the threshold for copy number variation is 20%, and the threshold for translocation is 10%. 5. The Eastern Cooperative Oncology Group (ECOG) score is 0, 1, or 2 points. The ECOG score of 3 points due to myeloma bone disease can be included. 6. Subjects had not received any anti-MM chemotherapy, extensive pelvic irradiation (more than half of the pelvic area), or anti-MM glucocorticoids, except those who used glucocorticoids for no more than 14 days to control symptoms. 7. Total bilirubin \< 1.5 × upper limit of normal (ULN) (total bilirubin in patients with Gilbert's syndrome can be restricted to \<3 × ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. 8. Creatinine clearance rate ≥ 30 mL/min (calculated by cockcroft and Gault formulas). 9. Routine blood test within 7 days before the first day of cycle 1 meets the following criteria: white blood cell (WBC) count ≥ 1.5×10\^9/L, absolute neutrophil count ≥ 1.0×10\^9/L, hemoglobin ≥ 75 g/L, and platelet count ≥ 75×10\^9/L (if bone marrow plasmacytes \< 50%) or platelet count ≥ 50×10\^9/L (if bone marrow plasmacytes ≥ 50%). 10. Patients receiving erythropoietin, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), platelet agonists (for example, eltrombopag, thrombopoietin, interleukin-11), must have a 2-week interval between receiving growth factor support and screening assessment. 11. Patients receiving blood product transfusions: at least 2 weeks between hemoglobin assessment and the last red blood cell (RBC) transfusion; at least one week between platelet assessment and the last platelet transfusion. 12. The subjects have no contraindications of receiving prophylactic anticoagulant drug recommended by the study. 13. Female subjects of childbearing age must meet the following two criteria: agree to take effective contraceptive measures from the date of signing the ICF to 3 months after the last administration of the drug; negative serum pregnancy test during screening. Exclusion Criteria: 1. Primary plasma cell leukemia. 2. Secondary amyloidosis. 3. Central nervous system (CNS) involvement. 4. Patients planning to receive allogeneic hematopoietic stem cell transplantation. 5. Patients with \> grade 2 peripheral neuropathy or ≥ grade 2 peripheral neuropathy with pain, regardless of receiving therapy or not. 6. Intolerance, allergy or contraindication to glucocorticoids, bortezomib, lenalidomide or daratumumab. 7. Clinically significant heart diseases: myocardial infarction before screening, or unstable or uncontrollable diseases related to or affecting cardiac function (such as unstable angina, congestive heart failure, New York Heart Association classification III-IV). Uncontrolled arrhythmia or clinically significant electrocardiogram (ECG) abnormalities. During screening, the 12-lead ECG showed a corrected QT interval (QTc) of \> 470 msec. 8. Uncontrolled diabetes mellitus and hypertension. 9. Patients with a history of other malignant tumors within 5 years. 10. Active human immunodeficiency virus (HIV) infection or positive serum HIV. 11. Active hepatitis B or C infection. Hepatitis serological test should be performed during screening. If hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) of patients are positive, DNA polymerase chain reaction (PCR) test should be confirmed as negative before enrollment (After anti hepatitis B virus treatment, DNA PCR test should be confirmed as negative before enrollment). If hepatitis C antibody is positive, RNA PCR test should be performed, and the results should be confirmed as negative before enrollment. 12. Pregnant or lactating women. 13. Expected life \< 6 months. 14. Any uncontrolled gastrointestinal dysfunction that affects the capacity to ingest or absorb the tablets. 15. A major surgery history within 2 weeks prior to the start of screening, or will not fully recover from the surgery, or are scheduled for surgery during the study period. Kyphoplasty or vertebroplasty is not considered as a major surgery. Notes: Subjects who plan to undergo surgery under local anesthesia can participate in the study. 16. Patients who received attenuated live vaccines within 4 weeks prior to the first administration of the study drug. 17. According to the researcher's judgment, any uncontrolled serious mental illness, physical illness, or other symptoms/conditions that may affect treatment, compliance, or the capacity to sign the ICF. 18. Patients with contraindications to any concomitant drugs or supportive therapy. 19. Patients with any diseases or complications that may interfere with the study procedure. 20. Patients who are unwilling or unable to follow the protocol.

Treatments Being Tested

DRUG

DVRd

The patients will receive 4 cycles of DVRd induction therapy. After achieving PR or better response, they will receive stem cell mobilization, collection and the following ASCT. Then, the patients will accept 4 cycles of DVRd consolidation and DVR maintenance therapy. Once they sustain MRD negative condition for at least 12 months, the patients will enter the maintenance stage of lenalidomide monotherapy. Otherwise, the triple drug maintenance therapy will be continued for a total of 24 cycles or until disease progression, death, intolerance, withdrawal due to other reasons, or termination/end of the study.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06158269), the sponsor (Institute of Hematology & Blood Diseases Hospital, China), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06158269 clinical trial studying?

Evaluate the efficacy of DVRd in patients with newly diagnosed double-hit multiple myeloma (MM) and the feasibility of minimal residual disease (MRD) guided maintenance therapy The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06158269?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06158269?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT06158269. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06158269. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.