MyelomaPhase 2NCT03184194
Nivolumab Combined With Daratumumab With or Without Low-dose Cyclophosphamide
A Phase 2 study testing nivolumab-daratumumab and nivolumab-daratumumab with low-dose cyclophosphamide in people with Myeloma, run by Amsterdam UMC, location VUmc at 9 sites in Netherlands.
Trial summary
Evaluation of the effect of nivolumab and daratumumab with or without low-dose cyclophosphamide in patients with relapsed/refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- nivolumab-daratumumab and nivolumab-daratumumab with low-dose cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 9 sitesNetherlands
- Study dates
- 21 Feb 2018to 25 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years
- Subject must have documented multiple myeloma as defined by the criteria below:
- Monoclonal plasma cells in the bone marrow ≥10% at some point in their disease history or presence of a biopsy proven plasmacytoma.
- Measurable disease as defined by any of the following:
- Serum monoclonal paraprotein (M-protein) level ≥5 g/L (0.5 g/dL); or urine M-protein level ≥200 mg/24 hours; or serum immunoglobulin free light chain ≥100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kappa lambda free light chain ratio (See Appendix A)
- Relapsed or refractory disease. Relapse is defined as progression of disease after an initial response to previous treatment, more than 60 days after cessation of treatment. Refractory disease is defined as <25% reduction in M-protein or progression of disease during treatment or within 60 days after cessation of treatment.
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- Subject had at least 2 prior anti-myeloma regimens. (Note: Induction, bone marrow transplant with or without maintenance therapy is considered one regimen.)
- Subject has developed lenalidomide-refractory disease during prior treatment with a lenalidomide-containing regimen. Refractory disease is defined as <25% reduction in M-protein or progression of disease during treatment or within 60 days after cessation of treatment.
- Subject received prior treatment with a proteasome inhibitor-containing regimen for at least 2 consecutive cycles.
- world health organization (WHO) performance 0, 1, or 2
- Life expectancy at least 3 months
- Written informed consent
Who cannot join
- Prior therapy with daratumumab or other anti-CD38 therapies
- Non-secretory myeloma
- Systemic amyloid light-chain (AL) amyloidosis or plasma cell leukemia (>2.0x109/L circulating plasma cells by standard differential) or Waldenstrom's macroglobulinemia
- Subject has known meningeal involvement of multiple myeloma
- Subject has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before start of treatment. This included subjects who have received a cumulative dose of corticosteroid greater than or equal to the equivalence of 140 mg prednisone or a single dose of corticosteroid greater than or equal to the equivalence of 40 mg/day dexamethasone within the 2-week period before start of treatment.
- Prior treatment with an anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
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- Subject has previously received an allogeneic stem cell transplantation (at any time)
- Inadequate marrow reserve as defined by a platelet count <75 x 109/L (<50 x 109/L if ≥50% of bone marrow mononucleated cells are plasma cells) or an absolute neutrophil count <1.0 x 109/L
- a) Subject has known chronic obstructive pulmonary disease (COPD) with an Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal.
- Subject has known 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).
- Subject has clinically significant cardiac disease, including:
- Myocardial infarction within 6 months before Cycle 1, Day 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV)
- Cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE] Version 4 Grade 2 or higher) or clinically significant ECG abnormalities.
- Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) >470 msec.
- Significant hepatic dysfunction (total bilirubin >1.5 times normal value (except subjects with Gilbert syndrome, who can have total bilirubin <3.0 mg/dL) or transaminases > 3 times normal value), unless related to myeloma
- Creatinine clearance <30 ml/min.
- Known hypersensitivity to components of the investigational products or severe allergic or anaphylactic reactions to humanized products.
- Subject has any concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.
- Subject is known to be seropositive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS), or any positive test for hepatitis B or hepatitis C indicating acute or chronic infection.
- History of active malignancy during the past 3 years, except squamous cell and basal cell carcinomas of the skin and carcinoma in situ of the cervix or breast and incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative, or malignancy that in the opinion of the local investigator, with concurrence with the principal investigator, is considered cured with minimal risk of recurrence within 3 years.
- Subjects with active interstitial pneumonitis
- Subjects with active, known or suspected autoimmune disease or inflammatory disorder (including inflammatory bowel disease [eg, colitis, Crohn's disease], systemic lupus erythematosus, Wegener's syndrome, myasthenia gravis, Grave's disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with a condition (other than MM) requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Subject is known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder) or the subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- Pregnant or lactating females
- Women of childbearing potential not willing to use adequate contraception, defined as hormonal birth control or intrauterine device, during the trial and for 1 year after the last dose of daratumumab or nivolumab or lenalidomide. Men who are sexually active with women of childbearing potential who are not willing to use adequate contraception for the duration of treatment with the study drugs and for 1 year after the last dose of daratumumab or nivolumab or lenalidomide.
- Peripheral neuropathy of ≥grade 2.
- History of allergy to study drug components
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
Meander MC
Amersfoort, Utrecht
VU University Medical Center
Amsterdam, North Holland, 1081HV
Rijnstate ziekenhuis
Arnhem, Ge
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland
UMC Groningen
Groningen, Provincie Groningen
MUMC
Maastricht, Li
St. Antonius Ziekenhuis
Nieuwegein, Utrecht
Radboud MC
Nijmegen, Ge
UMC Utrecht
Utrecht, Utrecht
About this study
Official title: A Phase 2 Study of Nivolumab Combined With Daratumumab With or Without Low-dose Cyclophosphamide in Relapsed/Refractory Multiple Myeloma
Evaluation of the effect of nivolumab and daratumumab with or without low-dose cyclophosphamide in patients with relapsed/refractory multiple myeloma.
Read the detailed description
Myeloma patients who develop bortezomib and lenalidomide-resistant disease have a very poor survival of only a median of 9 months, indicating that new agents are urgently needed. Recent studies have shown that daratumumab as a single agent is effective and well tolerated in these heavily pretreated MM patients. However, approximately 60% of patients do not achieve a partial response, and ultimately all patients will develop progressive disease during daratumumab therapy. In less pretreated patients daratumumab-based combinations (daratumumab plus lenalidomide-dexamethasone or daratumumab plus bortezomib-dexamethasone) were very effective and well tolerated. Therefore, in this study, the investigators will combine daratumumab with other agents to improve survival of heavily pretreated MM patients.
The PD-1 blocker nivolumab, as single agent, does not induce objective responses but induces stable disease in approximately 67% of relapsed/refractory MM patients. We have recently shown that daratumumab treatment results in increased T cell frequencies by eliminating CD38-positive immune suppressor cells, which probably contributes to the durable responses observed with daratumumab.
Cyclophosphamide, at a dose substantially lower than the maximum tolerated dose, has next to its direct anti-tumor activity serveral other effects including anti-angiogenic effects, induction of changes in the micro-environment, and also improvement of the anti-tumor immune response.
In this study, the investigators will combine two or three immune modulating agents with different mechanisms of action in order to improve the outcome of relapsed/refractory MM patients.
The investigators will evaluate in Part A, nivolumab combined with daratumumab with or without low-dose cyclophosphamide (total 40 patients). Based on efficacy and tolerability, the investigators will treat in Part B 20 additional patients with nivolumab combined with daratumumab either with or without low-dose cyclophosphamide based on tolerability and efficacy data obtained in Part A.
- Conditions
- Myeloma
- Being tested
- nivolumab-daratumumab, nivolumab-daratumumab with low-dose cyclophosphamide
- Keywords
- daratumumab, nivolumab, cyclophosphamide
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumab-daratumumabDrug
Also called Opdivo-darzalex
nivolumab-daratumumab will be given without low-dose cyclophosphamide until progression
nivolumab-daratumumab with low-dose cyclophosphamideDrug
Also called Opdivo-darzalex with endoxan
nivolumab-daratumumab with low-dose cyclophosphamide will be given until progression
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab-daratumumab | Experimental | daratumumab 16 mg/kg: 8 times once weekly, then 8 times every 2 weeks; then every 4 weeks; nivolumab: 240 mg every 2 weeks during first 6 cycles, followed by 480 mg every 4 weeks Receives: Drug: nivolumab-daratumumab |
| Nivolumab-daratumumab with cylclophosphamide | Experimental | daratumumab 16 mg/kg: weekly for 8 weeks, then Q2W for 16 weeks, ten Q4W thereafter; nivolumab: 240 mg every 2 weeks during first 6 cycles, followed by 480 mg every 4 weeks; low-dose cyclophosphamide 50mg daily on days 1-28 of each 28-day cycle; Receives: Drug: nivolumab-daratumumab with low-dose cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
the best response obtained during treatment
Measured: active treatment period up to 5 years
Secondary outcomes (4)
incidence of treatment emergent adverse events
type, frequency and severity of adverse events
Measured: active treatment period up to 5 years
progression-free survival
time from registration to progression or death from any cause, whichever comes first)
Measured: up to 5 years
overall survival
measured until death from any cause. Patients still alive or lost to follow up are censored at the date they were last known to be alive
Measured: up to 5 years
tumor expression profile as prognostic factor for response/survival
tumor expresssion profile by flow-cytometric detection
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start21 Feb 2018
- Primary completion25 Jan 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, UMC Utrecht, Maastricht University Medical Center, Meander Medical Center, St. Antonius Hospital, Isala, Albert Schweitzer Hospital, Radboud University Medical Center, University Medical Center Groningen, Rijnstate Hospital
- Responsible party
- Principal investigator, WCJ van de Donk, Amsterdam UMC, location VUmc
- Investigators
- Niels van de Donk, MD PhD, Principal investigator, VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184194
- Sponsor's protocol ID
- CA209-755
- Status last verified
- May 2024
- First submitted
- 2 Jun 2017
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Noori S, Verkleij CPM, Zajec M, Langerhorst P, Bosman PWC, de Rijke YB, Zweegman S, VanDuijn M, Luider T, van de Donk NWCJ, Jacobs JFM. Monitoring the M-protein of multiple myeloma patients treated with a combination of monoclonal antibodies: the laboratory solution to eliminate interference. Clin Chem Lab Med. 2021 Aug 16;59(12):1963-1971. doi: 10.1515/cclm-2021-0399. Print 2021 Nov 25.
PubMed 34392637
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Nivolumab Combined With Daratumumab With or Without Low-dose Cyclophosphamide in Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03184194
- Acronym / sponsor ID
- CA209-755
- Conditions
- Myeloma
- Keywords
- daratumumab, nivolumab, cyclophosphamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, UMC Utrecht, Maastricht University Medical Center, Meander Medical Center, St. Antonius Hospital, Isala, Albert Schweitzer Hospital, Radboud University Medical Center, University Medical Center Groningen, Rijnstate Hospital
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 12 Jun 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.
Evaluation of the effect of nivolumab and daratumumab with or without low-dose cyclophosphamide in patients with relapsed/refractory multiple myeloma.
Detailed description
Myeloma patients who develop bortezomib and lenalidomide-resistant disease have a very poor survival of only a median of 9 months, indicating that new agents are urgently needed. Recent studies have shown that daratumumab as a single agent is effective and well tolerated in these heavily pretreated MM patients. However, approximately 60% of patients do not achieve a partial response, and ultimately all patients will develop progressive disease during daratumumab therapy. In less pretreated patients daratumumab-based combinations (daratumumab plus lenalidomide-dexamethasone or daratumumab plus bortezomib-dexamethasone) were very effective and well tolerated. Therefore, in this study, the investigators will combine daratumumab with other agents to improve survival of heavily pretreated MM patients.
The PD-1 blocker nivolumab, as single agent, does not induce objective responses but induces stable disease in approximately 67% of relapsed/refractory MM patients. We have recently shown that daratumumab treatment results in increased T cell frequencies by eliminating CD38-positive immune suppressor cells, which probably contributes to the durable responses observed with daratumumab.
Cyclophosphamide, at a dose substantially lower than the maximum tolerated dose, has next to its direct anti-tumor activity serveral other effects including anti-angiogenic effects, induction of changes in the micro-environment, and also improvement of the anti-tumor immune response.
In this study, the investigators will combine two or three immune modulating agents with different mechanisms of action in order to improve the outcome of relapsed/refractory MM patients.
The investigators will evaluate in Part A, nivolumab combined with daratumumab with or without low-dose cyclophosphamide (total 40 patients). Based on efficacy and tolerability, the investigators will treat in Part B 20 additional patients with nivolumab combined with daratumumab either with or without low-dose cyclophosphamide based on tolerability and efficacy data obtained in Part A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab-daratumumab | Experimental | Drug: nivolumab-daratumumabdaratumumab 16 mg/kg: 8 times once weekly, then 8 times every 2 weeks; then every 4 weeks; nivolumab: 240 mg every 2 weeks during first 6 cycles, followed by 480 mg every 4 weeks |
| Nivolumab-daratumumab with cylclophosphamide | Experimental | Drug: nivolumab-daratumumab with low-dose cyclophosphamidedaratumumab 16 mg/kg: weekly for 8 weeks, then Q2W for 16 weeks, ten Q4W thereafter; nivolumab: 240 mg every 2 weeks during first 6 cycles, followed by 480 mg every 4 weeks; low-dose cyclophosphamide 50mg daily on days 1-28 of each 28-day cycle; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >=18 years
- Subject must have documented multiple myeloma as defined by the criteria below:
- Relapsed or refractory disease. Relapse is defined as progression of disease after an initial response to previous treatment, more than 60 days after cessation of treatment. Refractory disease is defined as <25% reduction in M-protein or progression of disease during treatment or within 60 days after cessation of treatment.
- Subject had at least 2 prior anti-myeloma regimens. (Note: Induction, bone marrow transplant with or without maintenance therapy is considered one regimen.)
- Subject has developed lenalidomide-refractory disease during prior treatment with a lenalidomide-containing regimen. Refractory disease is defined as <25% reduction in M-protein or progression of disease during treatment or within 60 days after cessation of treatment.
Key exclusion criteria (28 listed)
- Prior therapy with daratumumab or other anti-CD38 therapies
- Non-secretory myeloma
- Systemic amyloid light-chain (AL) amyloidosis or plasma cell leukemia (>2.0x109/L circulating plasma cells by standard differential) or Waldenstrom's macroglobulinemia
- Subject has known meningeal involvement of multiple myeloma
- Subject has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before start of treatment. This included subjects who have received a cumulative dose of corticosteroid greater than or equal to the equivalence of 140 mg prednisone or a single dose of corticosteroid greater than or equal to the equivalence of 40 mg/day dexamethasone within the 2-week period before start of treatment.
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 |
|---|---|---|
| nivolumab-daratumumabAlso: Opdivo-darzalexnivolumab-daratumumab will be given without low-dose cyclophosphamide until progression | Drug | Nivolumab-daratumumab |
| nivolumab-daratumumab with low-dose cyclophosphamideAlso: Opdivo-darzalex with endoxannivolumab-daratumumab with low-dose cyclophosphamide will be given until progression | Drug | Nivolumab-daratumumab with cylclophosphamide |
Primary outcome
overall response rate
Time frame: active treatment period up to 5 years
the best response obtained during treatment
4 secondary outcomes
incidence of treatment emergent adverse events
Time frame: active treatment period up to 5 years
progression-free survival
Time frame: up to 5 years
overall survival
Time frame: up to 5 years
tumor expression profile as prognostic factor for response/survival
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Derived from this study: PubMed 34392637Noori S, Verkleij CPM, Zajec M, Langerhorst P, Bosman PWC, de Rijke YB, Zweegman S, VanDuijn M, Luider T, van de Donk NWCJ, Jacobs JFM. Monitoring the M-protein of multiple myeloma patients treated with a combination of monoclonal antibodies: the laboratory solution to eliminate interference. Clin Chem Lab Med. 2021 Aug 16;59(12):1963-1971. doi: 10.1515/cclm-2021-0399. Print 2021 Nov 25.
- 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.
Niels van de Donk, MD PhD principal investigator
VUmc
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nivolumab-daratumumab and nivolumab-daratumumab with low-dose cyclophosphamide in people with Myeloma, run by Amsterdam UMC, location VUmc at 9 sites in Netherlands.
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 12 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: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
overall response rate (time frame: active treatment period up to 5 years). 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 NCT03184194, which also lists 1 linked publication.
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 22 May 2024.