Relapse and / or Refractory MyelomaPhase 2NCT03143036
Daratumumab, Thalidomide and Dexamethasone in Relapse and/or Refractory Myeloma
A Phase 2 study testing Daratumumab, thalidomide and dexamethasone in people with Relapse and / or Refractory Myeloma, run by National University Hospital, Singapore at 5 sites in 4 countries.
Trial summary
Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have survival of less than 1 year. A number of new drugs have been approved for the treatment of relapse myeloma in the last couple of years, including, Elotuzumab, Panobinostat, Ixazomib, carfilzomib and Pomalidomide. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Relapse and / or Refractory Myeloma
- What is being tested?
- Daratumumab, thalidomide and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 May 2018to 1 Jul 2022
- Phase
- Phase 2
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple myeloma, diagnosed according to standard criteria, with relapsing and refractory disease at study entry
- Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
- Serum M-protein ≥ 0.5g/dL, or
- In subjects without detectable serum M-protein, Urine M-protein ≥ 200mg/24 hour, or serum free light chai (sFLC) > 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio
- Must receive at least 1 line of prior treatment. (Induction therapy followed by stem cell transplantation and consolidation/maintenance therapy will be considered as one line of treatment)
- Must have relapsed disease and/or be refractory to prior treatment except for thalidomide or lenalidomide. Refractoriness is defined as disease progression on treatment or progression within 6 months after the last dose of a given therapy. Relapse is defined according to the criteria of IMWG
Show all 13Show fewer
- Males and females ≥ 18 years of age or > country's legal age for adult consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:
- Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is >50%)
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
- Calculated creatinine clearance ≥ 30mL/min.
- Written informed consent in accordance with federal, local and institutional guidelines
Who cannot join
- Female patients who are lactating or pregnant
- Multiple Myeloma of IgM subtype
- Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained
- POEMS syndrome
- Plasma cell leukemia or circulating plasma cells ≥ 2 x 109/L
- Waldenstrom's Macroglobulinaemia
Show all 28Show fewer
- Existing peripheral neuropathy of grade 2 or higher or presence of neuropathic pain
- Patients with known amyloidosis
- Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting Dara-TD treatment
- Focal radiation therapy within 7 days prior to start of Dara-TD. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of pomalidomide
- Immunotherapy (excluding steroids) 21 days prior to start of Dara-TD
- Major surgery (excluding kyphoplasty) within 28 days prior to start of Dara-TD
- Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained
- Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
- Patients with known cirrhosis
- Patients with creatinine clearance <30m/min
- Second malignancy within the past 3 years except:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Breast carcinoma in situ with full surgical resection
- Patients with myelodysplastic syndrome
- Patients with steroid or thalidomide hypersensitivity
- Patients previously treated with daratumumab or other anti-CD38 antibodies.
- Ongoing graft-versus-host disease
- Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to starting Dara-TD treatment
- Disease refractory to thalidomide or lenalidomide
- Contraindication to any of the required concomitant drugs or supportive treatments
- Any clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore
- Recruiting
Singapore General Hospital
Singapore
Hong Kong1 site, 1 recruiting
- Not yet recruiting
Queen Mary Hospital
Hong Kong
South Korea1 site, 1 recruiting
- Not yet recruiting
Samsung Medical Center
South Korea
About this study
Official title: Phase 2 Study of Daratumumab in Combination With Thalidomide and Dexamethasone in Relapse and / or Refractory Myeloma
Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have survival of less than 1 year. A number of new drugs have been approved for the treatment of relapse myeloma in the last couple of years, including, Elotuzumab, Panobinostat, Ixazomib, carfilzomib and Pomalidomide. However, most of these drugs either do not have good single agent activity or still belongs to the category of immunomodulatory drugs or proteasome inhibitors. Daratumumab is a monoclonal antibody against CD38 that is highly expressed on myeloma plasma cells. In phase ½ studies, it has impressive single agent activity in relapse and refractory myeloma with a very acceptable toxicity profile. This set the stage for combinations with daratumumab to increase efficacy and improve outcome of patients with myeloma. The use of immunomodulatory drugs, such as thalidomide and lenalidomide, has been shown to augment NK cell activity. NK cells are important mediator of antibody dependent cellular cytotoxicity. We therefore hypothesize that the combination of Daratumumab with thalidomide may therefore improve the efficacy of the treatment.
In this study, we will plan to perform a phase II trial using the Daratumumab, Thalidomide, Dexamethasone combination in 100 myeloma patients with relapse myeloma in Asia.
Read the detailed description
Daratumumab is a humanized antibody against CD38 which is expressed on myeloma cells. Daratumumab exhibited single agent activity in myeloma and is a promising new treatment. Recently, 2 phase 1 / 2 studies establishes the dosing regimen for Daratumumab and impressive single agent activity of about 30% response rates in patients who relapse after prior lenalidomide and bortezomib. Daratumumab also appear to be well tolerated. The most common toxicity is infusion-related and almost all confined to the first cycle. On the whole these are manageable with early intervention, concurrent corticosteroids and anti-histamines as well as slowing infusion rate. More recently, early results from 2 randomise study comparing Daratumumab plus lenalidomide and dexamethasone compared to lenalidomide and dexamethasone, and Daratumumab plus bortezomib and dexamethasone compared to bortezomib and dexamethasone, showed that the addition of Daratumumab significantly improved response and progression free survival, including a high minimal residual disease (MRD) negative rate of more than 20% in the relapse myeloma populations.
In addition, the use of immunomodulatory drugs, such as thalidomide and lenalidomide, has been shown to augment NK cell activity. NK cells are important mediator of antibody dependent cellular cytotoxicity, which is an important mechanism of action for Daratumumab. Furthermore, in the studies using another antibody target SLAMF7, Elotuzumab, the addition of dexamethasone greatly improve efficacy. Furthermore, thalidomide plus dexamethasone combination have a long history in myeloma and is relatively well tolerated and cost-effective. We therefore propose to add Daratumumab to thalidomide and dexamethasone, as this combination will be relatively easy to deliver in the Asian population because of availability and there is good rationale that such a combination will be synergistic and well-tolerated
Patients will be assessed every 28 days (+/-10 days). Patients shall receive the treatment until disease progression, unacceptable toxicity as determined by treating physician, withdrawal of consent or mortality (whichever occurs first). After disease progression, the treating physician should provide long-term follow-up data on disease status and survival. For patients who discontinued treatment before disease progression occurred, disease assessment measurements shall be performed once every 28 days (+/- 10 days) until disease progression. After patients have documented progression of disease, they will be followed for survival every 3 months (+/-10 days) until study closure or until patients withdraws consent, is lost to follow-up or until death, whichever comes first. For any patient who is lost to follow-up, the study site shall attempt to ascertain survival information via public database search.
- Conditions
- Relapse and / or Refractory Myeloma
- Being tested
- Daratumumab, thalidomide and dexamethasone
- Keywords
- daratumumab
- Medical subject headings
- Recurrence, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab, thalidomide and dexamethasoneDrug
Patients will be treated with with the following schedule. IV daratumumab 16mg/kg body weight weekly for weeks 1-8 followed by daratumumab 16mg/kg body weight once every 2 weeks from weeks 9 to 24 and then daratumumab 16mg/kg once every 4 weeks from weeks 25 onwards until disease progression; PO thalidomide 100mg daily for 1 year and PO Dexamethasone 40mg (starting dose of dexamethasone is 20mg once weekly for patients >75 years old) once weekly for 1 year (13 cycles, each cycle is 4 weeks). After 1 year, patient only continue on daratumumab until progression
Patients will be assessed every 28 days (+/-10 days).
| Study group | Role | What they receive |
|---|---|---|
| Daratumumab, thalidomide and dexamethasone | Experimental | Not described Receives: Drug: Daratumumab, thalidomide and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
To assess the progression free survival (PFS) for daratumumab in combination with thalidomide and dexamethasone in Asian patients with relapsed myeloma.
Measured: Time from commencement of treatment to disease progression or death, whichever occurs first, assessed up to 100 months
Secondary outcomes (4)
Overall Response Rate (ORR)
percentage of patients enrolled that achieve a complete response (CR), or stringent complete response (sCR), or very good partial response (VGPR), or partial response (PR) based on the International Myeloma Working Group criteria
Measured: anytime from commencement of treatment with daratumumab, thalidomide and dexamethasone to the end of studyaseline until disease progression, unmanageable adverse event or death, whichever occurs first, approximately up to 3 years
Overall survival (OS)
Time from commencement of treatment with daratumumab, thalidomide and dexamethasone to the date of death.
Measured: Up to approximately 5 years (anticipated) after the last participant is enrolled
Duration of response (DOR)
the time from first evidence of PR or VGPR, or CR, or sCR to confirmation of disease progression or death due to any cause.
Measured: the time from first evidence of PR or VGPR, or CR, or sCR to confirmation of disease progression or death due to any cause, assessed up to 100 months
Number of Participants affected by Adverse Events
assessed on the basis of the frequency and severity of adverse events
Measured: from the time of enrolment into study till 3 years from the date of the last patient randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 May 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Relapse and / or Refractory MyelomaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Model description
- This is a phase 2 study of the combination of Daratumumab, thalidomide and dexamethasone in 100 Asian patients with relapse or refractory multiple myeloma.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP, International Myeloma Foundation
- Responsible party
- Sponsor
- Investigators
- Wee Joo Chng, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143036
- Sponsor's protocol ID
- AMN004
- Status last verified
- May 2018
- First submitted
- 13 Apr 2017
- Last updated
- 7 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lonial S, Weiss BM, Usmani SZ, Singhal S, Chari A, Bahlis NJ, Belch A, Krishnan A, Vescio RA, Mateos MV, Mazumder A, Orlowski RZ, Sutherland HJ, Blade J, Scott EC, Oriol A, Berdeja J, Gharibo M, Stevens DA, LeBlanc R, Sebag M, Callander N, Jakubowiak A, White D, de la Rubia J, Richardson PG, Lisby S, Feng H, Uhlar CM, Khan I, Ahmadi T, Voorhees PM. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016 Apr 9;387(10027):1551-1560. doi: 10.1016/S0140-6736(15)01120-4. Epub 2016 Jan 7.
PubMed 26778538Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, Minnema MC, Lassen U, Krejcik J, Palumbo A, van de Donk NW, Ahmadi T, Khan I, Uhlar CM, Wang J, Sasser AK, Losic N, Lisby S, Basse L, Brun N, Richardson PG. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. N Engl J Med. 2015 Sep 24;373(13):1207-19. doi: 10.1056/NEJMoa1506348. Epub 2015 Aug 26.
PubMed 263085963. Palumbo A, Chanan-Khan A, Weisel K, et al. Phase III randomized controlled study of daratumumab, bortezomib and dexamethasone (DVd) versus bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma (RRMM): CASTOR study. J Clin Oncol 2016; 34 (Suppl abstr LBA4)
4. Dimopoulos MA, Oriol A, Nahi H, et al. An open-label, randomised phase 3 study of daratumumab, lenalidomide, dexamethasone (DRD) versus lenalidomide and dexamethasone (RD) in relapsed or refractory multiple myeloma (RRMM): POLLUX. EHA 2016 Abstract LB2238
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Daratumumab in Combination With Thalidomide and Dexamethasone in Relapse and / or Refractory Myeloma
- ClinicalTrials.gov ID
- NCT03143036
- Acronym / sponsor ID
- AMN004
- Conditions
- Relapse and / or Refractory Myeloma
- Keywords
- daratumumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Janssen, LP, International Myeloma Foundation
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 8 May 2017 (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.
Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have survival of less than 1 year. A number of new drugs have been approved for the treatment of relapse myeloma in the last couple of years, including, Elotuzumab, Panobinostat, Ixazomib, carfilzomib and Pomalidomide. However, most of these drugs either do not have good single agent activity or still belongs to the category of immunomodulatory drugs or proteasome inhibitors. Daratumumab is a monoclonal antibody against CD38 that is highly expressed on myeloma plasma cells. In phase ½ studies, it has impressive single agent activity in relapse and refractory myeloma with a very acceptable toxicity profile. This set the stage for combinations with daratumumab to increase efficacy and improve outcome of patients with myeloma. The use of immunomodulatory drugs, such as thalidomide and lenalidomide, has been shown to augment NK cell activity. NK cells are important mediator of antibody dependent cellular cytotoxicity. We therefore hypothesize that the combination of Daratumumab with thalidomide may therefore improve the efficacy of the treatment.
In this study, we will plan to perform a phase II trial using the Daratumumab, Thalidomide, Dexamethasone combination in 100 myeloma patients with relapse myeloma in Asia.
Detailed description
Daratumumab is a humanized antibody against CD38 which is expressed on myeloma cells. Daratumumab exhibited single agent activity in myeloma and is a promising new treatment. Recently, 2 phase 1 / 2 studies establishes the dosing regimen for Daratumumab and impressive single agent activity of about 30% response rates in patients who relapse after prior lenalidomide and bortezomib. Daratumumab also appear to be well tolerated. The most common toxicity is infusion-related and almost all confined to the first cycle. On the whole these are manageable with early intervention, concurrent corticosteroids and anti-histamines as well as slowing infusion rate. More recently, early results from 2 randomise study comparing Daratumumab plus lenalidomide and dexamethasone compared to lenalidomide and dexamethasone, and Daratumumab plus bortezomib and dexamethasone compared to bortezomib and dexamethasone, showed that the addition of Daratumumab significantly improved response and progression free survival, including a high minimal residual disease (MRD) negative rate of more than 20% in the relapse myeloma populations.
In addition, the use of immunomodulatory drugs, such as thalidomide and lenalidomide, has been shown to augment NK cell activity. NK cells are important mediator of antibody dependent cellular cytotoxicity, which is an important mechanism of action for Daratumumab. Furthermore, in the studies using another antibody target SLAMF7, Elotuzumab, the addition of dexamethasone greatly improve efficacy. Furthermore, thalidomide plus dexamethasone combination have a long history in myeloma and is relatively well tolerated and cost-effective. We therefore propose to add Daratumumab to thalidomide and dexamethasone, as this combination will be relatively easy to deliver in the Asian population because of availability and there is good rationale that such a combination will be synergistic and well-tolerated
Patients will be assessed every 28 days (+/-10 days). Patients shall receive the treatment until disease progression, unacceptable toxicity as determined by treating physician, withdrawal of consent or mortality (whichever occurs first). After disease progression, the treating physician should provide long-term follow-up data on disease status and survival. For patients who discontinued treatment before disease progression occurred, disease assessment measurements shall be performed once every 28 days (+/- 10 days) until disease progression. After patients have documented progression of disease, they will be followed for survival every 3 months (+/-10 days) until study closure or until patients withdraws consent, is lost to follow-up or until death, whichever comes first. For any patient who is lost to follow-up, the study site shall attempt to ascertain survival information via public database search.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase 2 study of the combination of Daratumumab, thalidomide and dexamethasone in 100 Asian patients with relapse or refractory multiple myeloma.
| Arm | Type | Receives |
|---|---|---|
| Daratumumab, thalidomide and dexamethasone | Experimental | Drug: Daratumumab, thalidomide and dexamethasone |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Multiple myeloma, diagnosed according to standard criteria, with relapsing and refractory disease at study entry
- Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
- Must receive at least 1 line of prior treatment. (Induction therapy followed by stem cell transplantation and consolidation/maintenance therapy will be considered as one line of treatment)
- Must have relapsed disease and/or be refractory to prior treatment except for thalidomide or lenalidomide. Refractoriness is defined as disease progression on treatment or progression within 6 months after the last dose of a given therapy. Relapse is defined according to the criteria of IMWG
- Males and females ≥ 18 years of age or > country's legal age for adult consent
Key exclusion criteria (28 listed)
- Female patients who are lactating or pregnant
- Multiple Myeloma of IgM subtype
- Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained
- POEMS syndrome
- Plasma cell leukemia or circulating plasma cells ≥ 2 x 109/L
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, thalidomide and dexamethasonePatients will be treated with with the following schedule. IV daratumumab 16mg/kg body weight weekly for weeks 1-8 followed by daratumumab 16mg/kg body weight once every 2 weeks from weeks 9 to 24 and then daratumumab 16mg/kg once every 4 weeks from weeks 25 onwards until disease progression; PO thalidomide 100mg daily for 1 year and PO Dexamethasone 40mg (starting dose of dexamethasone is 20mg once weekly for patients >75 years old) once weekly for 1 year (13 cycles, each cycle is 4 weeks). After 1 year, patient only continue on daratumumab until progression Patients will be assessed every 28 days (+/-10 days). | Drug | Daratumumab, thalidomide and dexamethasone |
Primary outcome
Progression free survival (PFS)
Time frame: Time from commencement of treatment to disease progression or death, whichever occurs first, assessed up to 100 months
To assess the progression free survival (PFS) for daratumumab in combination with thalidomide and dexamethasone in Asian patients with relapsed myeloma.
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: anytime from commencement of treatment with daratumumab, thalidomide and dexamethasone to the end of studyaseline until disease progression, unmanageable adverse event or death, whichever occurs first, approximately up to 3 years
Overall survival (OS)
Time frame: Up to approximately 5 years (anticipated) after the last participant is enrolled
Duration of response (DOR)
Time frame: the time from first evidence of PR or VGPR, or CR, or sCR to confirmation of disease progression or death due to any cause, assessed up to 100 months
Number of Participants affected by Adverse Events
Time frame: from the time of enrolment into study till 3 years from the date of the last patient randomized
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Background: PubMed 26778538Lonial S, Weiss BM, Usmani SZ, Singhal S, Chari A, Bahlis NJ, Belch A, Krishnan A, Vescio RA, Mateos MV, Mazumder A, Orlowski RZ, Sutherland HJ, Blade J, Scott EC, Oriol A, Berdeja J, Gharibo M, Stevens DA, LeBlanc R, Sebag M, Callander N, Jakubowiak A, White D, de la Rubia J, Richardson PG, Lisby S, Feng H, Uhlar CM, Khan I, Ahmadi T, Voorhees PM. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016 Apr 9;387(10027):1551-1560. doi: 10.1016/S0140-6736(15)01120-4. Epub 2016 Jan 7.
- Background: PubMed 26308596Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, Minnema MC, Lassen U, Krejcik J, Palumbo A, van de Donk NW, Ahmadi T, Khan I, Uhlar CM, Wang J, Sasser AK, Losic N, Lisby S, Basse L, Brun N, Richardson PG. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. N Engl J Med. 2015 Sep 24;373(13):1207-19. doi: 10.1056/NEJMoa1506348. Epub 2015 Aug 26.
- Background3. Palumbo A, Chanan-Khan A, Weisel K, et al. Phase III randomized controlled study of daratumumab, bortezomib and dexamethasone (DVd) versus bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma (RRMM): CASTOR study. J Clin Oncol 2016; 34 (Suppl abstr LBA4)
- Background4. Dimopoulos MA, Oriol A, Nahi H, et al. An open-label, randomised phase 3 study of daratumumab, lenalidomide, dexamethasone (DRD) versus lenalidomide and dexamethasone (RD) in relapsed or refractory multiple myeloma (RRMM): POLLUX. EHA 2016 Abstract LB2238
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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.
Wee Joo Chng principal investigator
National University Hospital, Singapore
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daratumumab, thalidomide and dexamethasone in people with Relapse and / or Refractory Myeloma, run by National University Hospital, Singapore at 5 sites in 4 countries.
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 28 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: status not confirmed, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Singapore, Hong Kong, South Korea, Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wee Joo Chng (6779 5555, mdccwj@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Time from commencement of treatment to disease progression or death, whichever occurs first, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03143036, which also lists 4 linked publications.
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 7 Jun 2018.