Multiple MyelomaPhase 2NCT06158269
DVRd in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma
A Phase 2 study testing DVRd in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- DVRd
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2023to Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signing the Informed Consent Form (ICF).
- Age: ≥ 18 years old and < 70 years old.
- 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).
- 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%.
- 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.
- 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.
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- 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.
- Creatinine clearance rate ≥ 30 mL/min (calculated by cockcroft and Gault formulas).
- 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%).
- 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.
- 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.
- The subjects have no contraindications of receiving prophylactic anticoagulant drug recommended by the study.
- 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.
Who cannot join
- Primary plasma cell leukemia.
- Secondary amyloidosis.
- Central nervous system (CNS) involvement.
- Patients planning to receive allogeneic hematopoietic stem cell transplantation.
- Patients with > grade 2 peripheral neuropathy or ≥ grade 2 peripheral neuropathy with pain, regardless of receiving therapy or not.
- Intolerance, allergy or contraindication to glucocorticoids, bortezomib, lenalidomide or daratumumab.
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- 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.
- Uncontrolled diabetes mellitus and hypertension.
- Patients with a history of other malignant tumors within 5 years.
- Active human immunodeficiency virus (HIV) infection or positive serum HIV.
- 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.
- Pregnant or lactating women.
- Expected life < 6 months.
- Any uncontrolled gastrointestinal dysfunction that affects the capacity to ingest or absorb the tablets.
- 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.
- Patients who received attenuated live vaccines within 4 weeks prior to the first administration of the study drug.
- 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.
- Patients with contraindications to any concomitant drugs or supportive therapy.
- Patients with any diseases or complications that may interfere with the study procedure.
- Patients who are unwilling or unable to follow the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin
Lugui Qiu, 0086-022-23909171, qiulg@ihcams.ac.cn
About this study
Official title: 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
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
Read the detailed description
This study is a single arm phase II study treating patients with newly diagnosed double-hit MM with DVRd induction therapy. This study will enroll 40 patients with double-hit MM who are eligible for autologous stem cell transplantation (ASCT) to evaluate the efficacy of DVRd and the feasibility of MRD guided maintenance therapy. The protocol is: DVRd induction therapy for 4 cycles, followed by ASCT, then DVRd consolidation therapy for 4 cycles, and the last DVR maintenance therapy. After induction therapy, during 60 to 90 days after ASCT, after consolidation therapy, and every 4 cycles during maintenance therapy, the patients will accept MRD monitoring. Patients with MRD negative for at least 12 months will enter the maintenance phase of lenalidomide monotherapy. Otherwise, they will accept DVR maintenance therapy for a total of 24 cycles or until disease progression, death, intolerance, withdrawal due to other reasons, or termination/end of the study.
- Conditions
- Multiple Myeloma
- Being tested
- DVRd
- Keywords
- double-hit, daratumumab, bortezomib, lenalidomide, minimal residual disease, tailored maintenance therapy
- Medical subject headings
- Multiple Myeloma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVRdDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| DVRd group | Experimental | Daratumumab combined with bortezomib, lenalidomide and dexamethasone Receives: Drug: DVRd |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD negative rate
MRD detected by next generation sequencing
Measured: through study completion, an average of 3 year
Secondary outcomes (7)
Duration of negative MRD
From the first record of negative MRD to the first record of positive MRD or the end of follow-up, whichever came first, assessed up to 3 year
Measured: through study completion, an average of 3 year
stringent complete response (sCR)
stringent complete response
Measured: through study completion, an average of 3 year
ORR
Overall response rate (ORR): Complete response (CR) + Very good partial response (VGPR) + Partial response (PR)
Measured: through study completion, an average of 3 year
Duration of response (DOR)
The duration from the first record of achieving at least PR to the occurrence of progressive disease (PD) or death caused by PD, whichever occurs at first
Measured: through study completion, an average of 3 year
Mobilization success rate
Mobilization success rate, high-quality mobilization rate and poor-quality mobilization
Measured: after all patients accepted stem cell mobilization, an average of 1.5 year
Progression-free survival (PFS)
From date of enrollment of patients until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 year
Measured: through study completion, an average of 3 year
Overall survival (OS)
From date of enrollment of patients until the date of death from any cause, whichever came first, assessed up to 3 year
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 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 Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiu Lugui, Institute of Hematology & Blood Diseases Hospital, China
- Investigators
- Lugui Qiu, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158269
- Sponsor's protocol ID
- MMY2094
- Status last verified
- Nov 2023
- First submitted
- 21 Sep 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06158269
- Acronym / sponsor ID
- MMY2094
- Conditions
- Multiple Myeloma
- Keywords
- double-hit, daratumumab, bortezomib, lenalidomide, minimal residual disease, tailored maintenance therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Dec 2023 (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.
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
Detailed description
This study is a single arm phase II study treating patients with newly diagnosed double-hit MM with DVRd induction therapy. This study will enroll 40 patients with double-hit MM who are eligible for autologous stem cell transplantation (ASCT) to evaluate the efficacy of DVRd and the feasibility of MRD guided maintenance therapy. The protocol is: DVRd induction therapy for 4 cycles, followed by ASCT, then DVRd consolidation therapy for 4 cycles, and the last DVR maintenance therapy. After induction therapy, during 60 to 90 days after ASCT, after consolidation therapy, and every 4 cycles during maintenance therapy, the patients will accept MRD monitoring. Patients with MRD negative for at least 12 months will enter the maintenance phase of lenalidomide monotherapy. Otherwise, they will accept DVR maintenance therapy for a total of 24 cycles or until disease progression, death, intolerance, withdrawal due to other reasons, or termination/end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DVRd group | Experimental | Drug: DVRdDaratumumab combined with bortezomib, lenalidomide and dexamethasone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily signing the Informed Consent Form (ICF).
- Age: ≥ 18 years old and < 70 years old.
- 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).
- 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%.
- 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.
Key exclusion criteria (20 listed)
- Primary plasma cell leukemia.
- Secondary amyloidosis.
- Central nervous system (CNS) involvement.
- Patients planning to receive allogeneic hematopoietic stem cell transplantation.
- Patients with > grade 2 peripheral neuropathy or ≥ grade 2 peripheral neuropathy with pain, regardless of receiving therapy or not.
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 |
|---|---|---|
| DVRdThe 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. | Drug | DVRd group |
Primary outcome
MRD negative rate
Time frame: through study completion, an average of 3 year
MRD detected by next generation sequencing
7 secondary outcomes
Duration of negative MRD
Time frame: through study completion, an average of 3 year
stringent complete response (sCR)
Time frame: through study completion, an average of 3 year
ORR
Time frame: through study completion, an average of 3 year
Duration of response (DOR)
Time frame: through study completion, an average of 3 year
Mobilization success rate
Time frame: after all patients accepted stem cell mobilization, an average of 1.5 year
Progression-free survival (PFS)
Time frame: through study completion, an average of 3 year
Overall survival (OS)
Time frame: through study completion, an average of 3 year
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 6 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Lugui Qiu principal investigator
Institute of Hematology & Blood Diseases Hospital, China
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 DVRd in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 13 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 6 Dec 2023. 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 China. 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?
Contact Lugui Qiu (0086-022-23909171, qiulg@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD negative rate (time frame: through study completion, an average of 3 year). 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 6 Dec 2023.