Multiple MyelomaPhase 3NCT04288765
Carfilzomib, Daratumumab, Lenalidomide and Dexamethasone as First Line Treatment in Multiple Myeloma
A Phase 3 study testing Daratumumab Only Product in Parenteral Dose Form in people with Multiple Myeloma, run by Grupo Cooperativo de Hemopatías Malignas at 1 site in Mexico.
Trial summary
Carfilzomib in combination with lenalidomide, daratumumab and dexamethasone (KRDd) can induce profound clinical responses. The investigators want to observe the effectiveness of the quadruple therapy of carfilzomib, lenalidomide, daratumumab and dexamethasone on patients receiving 8 cycles of KRDd with autologous stem… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Daratumumab Only Product in Parenteral Dose Form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2020to 28 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed and previously untreated multiple myeloma by the International Myeloma Working Group criteria that requires treatment based on: Presence of elevated calcium, renal failure, anemia and/or bone lesions (CRAB) Clonal bone marrow plasma cells ³ 60% Involved/uninvolved serum free light chain ratio ³ 100 >1 focal lesions on MRI studies (³5 mm in size)
- Age > 18 years
- Functional stage of 0 - 1 measured by the Eastern Cooperative Oncology Group (ECOG) scale.
- Capacity and willingness to provide a written informed consent.
Who cannot join
- POEMS syndrome
- Systemic amyloidosis
- Plasma cells leukemia
- Radiotherapy on multiple sites on the period of 4 weeks before the initiation of treatment (1 week if it is one region)
- Improper liver function: total bilirubin > 1.5 x upper limit of normal (ULN) or > 3 x ULN in patients with Gilbert syndrome, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3.0 x ULN.
- Non-controlled systematic active infection (viral, bacterial and/or fungic).
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- Patients with known infection by human immunodeficiency virus (HIV).
- Active infection by hepatitis B.
- Active infection by hepatitis C.
- Significant cardiovascular diseases as uncontrolled or symptomatic arrhythmias, congestive heart failure or acute myocardial infarction within 2 months prior to screening, or any New York Heart Association (NYHA) class 3 or 4 heart disease.
- Diagnosis of previous malignancies for 2 years, with exception of patients with basal or squamous cell carcinoma or "in situ" carcinoma of cervix or breast.
- History of allergic reaction or severe anaphylaxis to humanized or murine monoclonal antibodies.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Grupo Cooperativo de Hemopatías Malignas
Huixquilucan, State of Mexico, 52763
About this study
Carfilzomib in combination with lenalidomide, daratumumab and dexamethasone (KRDd) can induce profound clinical responses. The investigators want to observe the effectiveness of the quadruple therapy of carfilzomib, lenalidomide, daratumumab and dexamethasone on patients receiving 8 cycles of KRDd with autologous stem cell transplantation versus patients with 8 cycles of KRDd without autologous stem cell transplantation.
- Conditions
- Multiple Myeloma
- Being tested
- Daratumumab Only Product in Parenteral Dose Form
- Keywords
- Newly diagnosed
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab Only Product in Parenteral Dose FormDrug
Also called Lenalidomide, Carfilzomib, Dexamethasone
Induction = 8 cycles Carfilzomib on Day 1st, 8th and 15th Lenalidomide: Day 1 to 21
Daratumumab:
Cycles 1-2: weekly Cycles 3-4: every two weeks Cycles 5-8: every month Dexamethasone: 40 mg weekly
| Study group | Role | What they receive |
|---|---|---|
| Group A - Non transplant | Experimental | Carfilzomib Lenalidomide Daratumumab Dexamethasone Receives: Drug: Daratumumab Only Product in Parenteral Dose Form |
| Group B - transplant | Active comparator | Carfilzomib Lenalidomide Daratumumab Dexamethasone Autologous stem cell transplantation (ASCT) Receives: Drug: Daratumumab Only Product in Parenteral Dose Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response with negative minimal residual disease
Complete response with MRD-negative disease measured by inmunophenotype with the International Myeloma Working Group response criteria
Measured: 10 months
Secondary outcomes (3)
Overall survival
Overall survival measured on months on both study groups
Measured: 36 months
Progression free survival
Progression free survival measured on months from the time to the end of treatment to disease progression on both study groups
Measured: 36 months
Rate of Adverse Events
Rate of adverse events rated grade ≥3 by CTCAE 5.0
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Why it stopped: incomplete recruitment
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with newly diagnosed and previously untreated multiple myeloma living in Mexico that are fit for a quadruple therapy for multiple myeloma. Those patients that aren't fit or unavailable for transplant will go to the continuous treatment arm. The stratification of the study will be done by age and by cytogenetic risk.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Cooperativo de Hemopatías Malignas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288765
- Sponsor's protocol ID
- HAL 319/2019
- Status last verified
- Jul 2021
- First submitted
- 26 Feb 2020
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carfilzomib, Daratumumab, Lenalidomide and Dexamethasone as First Line Treatment in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04288765
- Acronym / sponsor ID
- HAL 319/2019
- Conditions
- Multiple Myeloma
- Keywords
- Newly diagnosed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: incomplete recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Grupo Cooperativo de Hemopatías MalignasUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 28 Feb 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.
Carfilzomib in combination with lenalidomide, daratumumab and dexamethasone (KRDd) can induce profound clinical responses. The investigators want to observe the effectiveness of the quadruple therapy of carfilzomib, lenalidomide, daratumumab and dexamethasone on patients receiving 8 cycles of KRDd with autologous stem cell transplantation versus patients with 8 cycles of KRDd without autologous stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with newly diagnosed and previously untreated multiple myeloma living in Mexico that are fit for a quadruple therapy for multiple myeloma. Those patients that aren't fit or unavailable for transplant will go to the continuous treatment arm. The stratification of the study will be done by age and by cytogenetic risk.
| Arm | Type | Receives |
|---|---|---|
| Group A - Non transplant | Experimental | Drug: Daratumumab Only Product in Parenteral Dose FormCarfilzomib Lenalidomide Daratumumab Dexamethasone |
| Group B - transplant | Active comparator | Drug: Daratumumab Only Product in Parenteral Dose FormCarfilzomib Lenalidomide Daratumumab Dexamethasone Autologous stem cell transplantation (ASCT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with newly diagnosed and previously untreated multiple myeloma by the International Myeloma Working Group criteria that requires treatment based on: Presence of elevated calcium, renal failure, anemia and/or bone lesions (CRAB) Clonal bone marrow plasma cells ³ 60% Involved/uninvolved serum free light chain ratio ³ 100 >1 focal lesions on MRI studies (³5 mm in size)
- Age > 18 years
- Functional stage of 0 - 1 measured by the Eastern Cooperative Oncology Group (ECOG) scale.
- Capacity and willingness to provide a written informed consent.
Key exclusion criteria (13 listed)
- POEMS syndrome
- Systemic amyloidosis
- Plasma cells leukemia
- Radiotherapy on multiple sites on the period of 4 weeks before the initiation of treatment (1 week if it is one region)
- Improper liver function: total bilirubin > 1.5 x upper limit of normal (ULN) or > 3 x ULN in patients with Gilbert syndrome, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3.0 x ULN.
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 |
|---|---|---|
| Daratumumab Only Product in Parenteral Dose FormAlso: Lenalidomide, Carfilzomib, DexamethasoneInduction = 8 cycles Carfilzomib on Day 1st, 8th and 15th Lenalidomide: Day 1 to 21 Daratumumab: Cycles 1-2: weekly Cycles 3-4: every two weeks Cycles 5-8: every month Dexamethasone: 40 mg weekly | Drug | Group A - Non transplant, Group B - transplant |
Primary outcome
Complete response with negative minimal residual disease
Time frame: 10 months
Complete response with MRD-negative disease measured by inmunophenotype with the International Myeloma Working Group response criteria
3 secondary outcomes
Overall survival
Time frame: 36 months
Progression free survival
Time frame: 36 months
Rate of Adverse Events
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daratumumab Only Product in Parenteral Dose Form in people with Multiple Myeloma, run by Grupo Cooperativo de Hemopatías Malignas at 1 site in Mexico.
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 4 inclusion and 13 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: withdrawn, as of the sponsor's last update on 9 Jul 2021. 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 Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Complete response with negative minimal residual disease (time frame: 10 months). 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 9 Jul 2021.