Multiple MyelomaPhase 3CTdNCT02248428
Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma
A Phase 3 study testing Clarithromycin, Thalidomide and Cyclophosphamide in people with Multiple Myeloma, run by Jinling Hospital, China at 1 site in China.
Trial summary
Due to economic reasons, thalidomide is still widely used as a first line drug for Multiple Myeloma patients in China. However,the efficacy of CTd is still lower than the therapeutic regimens with new drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Clarithromycin, Thalidomide and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Diagnosed with active multiple myeloma
- Previously untreated
- Karnofsky performance status(KPS) ≥50（KPS<50 will be allowed if related to bony disease）
- New York Heart Association(NYHA) functional ≤class III
Who cannot join
- Hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics;
- Concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin;
- A history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin.
- Impaired renal function,Creatinine ≥221umol/L；
- Pregnant or breast feeding females.
- Any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210002
Zhai, doctor, 13951947646, ypzhai@medmail.com.cn
Yongping Zhai, doctor
About this study
Official title: Clarithromycin Plus CTd (Cyclophosphamide,Thalidomide and Dexamethasone)Regimen for Patients With Newly Diagnosed Multiple Myeloma:a Phase 3 , Multicenter,Randomized, Open-Label Trial.
Due to economic reasons, thalidomide is still widely used as a first line drug for Multiple Myeloma patients in China. However,the efficacy of CTd is still lower than the therapeutic regimens with new drugs. Clarithromycin may have partly efficacy in association with steroids and thalidomide for Multiple Myeloma patients. This multicenter, randomized, phase 3 clinical trial is proposed to explore whether clarithromycin could potentiate responsiveness of CTd (Cyclophosphamide, Thalidomide and Dexamethasone) regimen in Newly Diagnosed Multiple Myeloma patients. The trial will also evaluate the side effects caused by the combination of these drugs.
Read the detailed description
This phase III,randomized controlled trial will enroll 130(65 each arm) newly diagnosed patients with active disease from 4 medical centers in East China.
The participants are randomly equally selected to receive BiCTd regimen arm or CTd regimen arm. The treatment consists of eight induction and consolidation therapy followed by maintenance therapy.
BiCTd(Clarithromycin, Cyclophosphamide, Thalidomide and Dexamethasone) regimen arm：
Induction and consolidation Phase:
All patients will also receive aspirin 100mg PO QD while receiving BiCTd. Aspirin will continue through maintenance.
Clarithromycin 500 mg orally daily on days 1-28,thalidomide 100-200mg orally on days d1-28, dexamethasone 40 mg orally on days on 1,8,15,22, and cyclophosphamide 300 mg/m^2 intravenously on day 1-3. Eight Cycles were repeated every 28 days.
If efficacy <PR after 4 cycles of induction， or disease progression at anytime，patients will be quitted.
Maintenance Therapy:
Patients who complete the induction and consolidation regimen could be started on maintenance therapy as follows: Maintenance with CP (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,repeated every 28 days) regimen until disease progression.
CTd regimen arm：
Induction and consolidation Phase:
All patients will also receive aspirin 100mg PO QD while receiving CTd. Aspirin will continue through maintenance.
Thalidomide 100-200mg orally on days d1-28, dexamethasone 40 mg orally on days on 1,8,15,22, and cyclophosphamide 300 mg/m^2 intravenously on day 1-3. Eight Cycles were repeated every 28 days.
If efficacy <PR after 4 cycles of induction， or disease progression at anytime，patients will be quitted.
If no further reduction in the serum and urine M protein in the next cycle，patients may cross over to BiCTd regimen.
Maintenance Therapy:
Patients who complete the induction and consolidation regimen could be started on maintenance therapy as follows: Maintenance with CP (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,repeated every 28 days) regimen until disease progression Then, patients will be followed up for 24 months after chemotherapy. The investigators will record all the laboratory and clinical investigations to assess response at different points of the study. We also assess adverse events (AEs), as graded according to NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) Version 4.0.Response categories were based on the International Myeloma Working Group uniform response criteria.
- Conditions
- Multiple Myeloma
- Being tested
- Clarithromycin, Thalidomide, Cyclophosphamide, Dexamethasone
- Keywords
- multiple myeloma, Clarithromycin, CTd
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
Also called Abbott- 56268, Biaxin, CLARITH
500mg orally daily on days 1-28,repeated every 28 days
ThalidomideDrug
Also called Distaval, Thalomid
Thalidomide 100-200mg orally per night on days 1-28,repeated every 28 days
CyclophosphamideDrug
Also called Endoxan, Cytoxan, Neosar, Procytox
300mg/m^2 intravenously daily on day 1-3,repeated every 28 days
DexamethasoneDrug
Also called Decadron, Aeroseb-Dex, Decaderm, DM
40 mg orally weekly on days 1,8,15,22,repeated every 28 days
| Study group | Role | What they receive |
|---|---|---|
| BiCTd regimen | Experimental | Induction and consolidation therapy: BiCTd regimen for 8 cycles. Patients received Clarithromycin 500 mg orally on days 1-28,thalidomide 100-200mg orally on days d1-28, dexamethasone 40mg orally on days on 1,8,15,22, and cyclophosphamide 300mg/m^2 intravenously on day 1-3. Cycles were repeated every 28 days.
Maintenance therapy:CP regimen (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,repeated every 28 days) until disease progression.
If efficacy <PR after 4 cycles of induction or disease progression at anytime，patients will be quitted. Receives: Drug: Clarithromycin; Drug: Thalidomide; Drug: Cyclophosphamide; Drug: Dexamethasone |
| CTd regimen | Active comparator | Induction and consolidation therapy: CTd regimen for 8 cycles. Patients received thalidomide 100-200mg orally on days d1-28, dexamethasone 40 mg orally on days on 1,8,15,22, and cyclophosphamide 300 mg/m^2 intravenously on day 1-3. Cycles were repeated every 28 days.
Maintenance therapy:CP regimen (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,28 Days per Cycle) until disease progression.
If efficacy <PR after 4 cycles of induction or disease progression at anytime，patients will be quitted.
If no further reduction in the serum and urine M protein in the next cycle，patients may cross over to BiCTd regimen. Receives: Drug: Thalidomide; Drug: Cyclophosphamide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Very Good Partial Remission (VGPR) or Better
Quality of response: % Complete Response (CR) + Very Good Partial Remission (VGPR) to induction BiCTd or CTd as assessed using International Myeloma Working Group Response Definitions. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.
Measured: up to 4 months
Secondary outcomes (3)
Median Progression Free Survival (PFS) in months
PFS: Time from study entry to progression/relapse or death from study entry to death of any cause, assessed using International Myeloma Working Group Response Definitions. Progressive Disease (PD): One of the following criteria must be met: a. Increase of 25% or greater in serum M protein (absolute increase greater or equal to 0.5g/dl); b. Increase of 25% or greater in urine M protein (absolute increase greater than 200 mg/24h); c. Increase of 25% or greater in the difference between the involved and uninvolved free light chain (absolute increase greater than 10 mg/dl); d. Increase of 25% or greater in bone marrow plasma cell percentage (absolute percent greater than 5% in case the patient was in CR and 10% otherwise); i.e. Definite development of new bone lesions or soft tissue plasmacytomas, or increase in the size of existing plasmacytomas by greater or equal to 25%. Development of hypercalcemia (serum calcium > 11.5 mg/dl) attributable only to the plasma cell dyscrasia.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 Months
2 Year Overall Survival (OS) Rate
Percentage of participants with Overall Survival in response to BiCTd or CTd in newly diagnosed multiple myeloma patients with active disease. Overall survival is time from study entry to death of any cause.
Measured: up to 24 months
Number of participants with adverse events
Adverse events (AEs) were graded according to NCI-CTCAE Version 4.0
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startApr 2012
- Primary completionSep 2019 (estimated)
- Study completionSep 2020 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongping Zhai, Jinling Hospital, China
- Investigators
- Yongping Zhai, doctor, Study chair, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248428
- Sponsor's protocol ID
- NAB20140324
- Acronym
- CTd
- Status last verified
- Sep 2017
- First submitted
- 22 Sep 2014
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clarithromycin Plus CTd (Cyclophosphamide,Thalidomide and Dexamethasone)Regimen for Patients With Newly Diagnosed Multiple Myeloma:a Phase 3 , Multicenter,Randomized, Open-Label Trial.
- ClinicalTrials.gov ID
- NCT02248428
- Acronym / sponsor ID
- CTd / NAB20140324
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, Clarithromycin, CTd
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 25 Sep 2014 (estimated)
- 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.
Due to economic reasons, thalidomide is still widely used as a first line drug for Multiple Myeloma patients in China. However,the efficacy of CTd is still lower than the therapeutic regimens with new drugs. Clarithromycin may have partly efficacy in association with steroids and thalidomide for Multiple Myeloma patients. This multicenter, randomized, phase 3 clinical trial is proposed to explore whether clarithromycin could potentiate responsiveness of CTd (Cyclophosphamide, Thalidomide and Dexamethasone) regimen in Newly Diagnosed Multiple Myeloma patients. The trial will also evaluate the side effects caused by the combination of these drugs.
Detailed description
This phase III,randomized controlled trial will enroll 130(65 each arm) newly diagnosed patients with active disease from 4 medical centers in East China.
The participants are randomly equally selected to receive BiCTd regimen arm or CTd regimen arm. The treatment consists of eight induction and consolidation therapy followed by maintenance therapy.
BiCTd(Clarithromycin, Cyclophosphamide, Thalidomide and Dexamethasone) regimen arm：
Induction and consolidation Phase:
All patients will also receive aspirin 100mg PO QD while receiving BiCTd. Aspirin will continue through maintenance.
Clarithromycin 500 mg orally daily on days 1-28,thalidomide 100-200mg orally on days d1-28, dexamethasone 40 mg orally on days on 1,8,15,22, and cyclophosphamide 300 mg/m^2 intravenously on day 1-3. Eight Cycles were repeated every 28 days.
If efficacy <PR after 4 cycles of induction， or disease progression at anytime，patients will be quitted.
Maintenance Therapy:
Patients who complete the induction and consolidation regimen could be started on maintenance therapy as follows: Maintenance with CP (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,repeated every 28 days) regimen until disease progression.
CTd regimen arm：
Induction and consolidation Phase:
All patients will also receive aspirin 100mg PO QD while receiving CTd. Aspirin will continue through maintenance.
Thalidomide 100-200mg orally on days d1-28, dexamethasone 40 mg orally on days on 1,8,15,22, and cyclophosphamide 300 mg/m^2 intravenously on day 1-3. Eight Cycles were repeated every 28 days.
If efficacy <PR after 4 cycles of induction， or disease progression at anytime，patients will be quitted.
If no further reduction in the serum and urine M protein in the next cycle，patients may cross over to BiCTd regimen.
Maintenance Therapy:
Patients who complete the induction and consolidation regimen could be started on maintenance therapy as follows: Maintenance with CP (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,repeated every 28 days) regimen until disease progression Then, patients will be followed up for 24 months after chemotherapy. The investigators will record all the laboratory and clinical investigations to assess response at different points of the study. We also assess adverse events (AEs), as graded according to NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) Version 4.0.Response categories were based on the International Myeloma Working Group uniform response criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiCTd regimen | Experimental | Drug: Clarithromycin, Drug: Thalidomide, Drug: Cyclophosphamide, Drug: DexamethasoneInduction and consolidation therapy: BiCTd regimen for 8 cycles. Patients received Clarithromycin 500 mg orally on days 1-28,thalidomide 100-200mg orally on days d1-28, dexamethasone 40mg orally on days on 1,8,15,22, and cyclophosphamide 300mg/m^2 intravenously on day 1-3. Cycles were repeated every 28 days. Maintenance therapy:CP regimen (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,repeated every 28 days) until disease progression. If efficacy <PR after 4 cycles of induction or disease progression at anytime，patients will be quitted. |
| CTd regimen | Active comparator | Drug: Thalidomide, Drug: Cyclophosphamide, Drug: DexamethasoneInduction and consolidation therapy: CTd regimen for 8 cycles. Patients received thalidomide 100-200mg orally on days d1-28, dexamethasone 40 mg orally on days on 1,8,15,22, and cyclophosphamide 300 mg/m^2 intravenously on day 1-3. Cycles were repeated every 28 days. Maintenance therapy:CP regimen (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,28 Days per Cycle) until disease progression. If efficacy <PR after 4 cycles of induction or disease progression at anytime，patients will be quitted. If no further reduction in the serum and urine M protein in the next cycle，patients may cross over to BiCTd regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Diagnosed with active multiple myeloma
- Previously untreated
- Karnofsky performance status(KPS) ≥50（KPS<50 will be allowed if related to bony disease）
Key exclusion criteria (6 listed)
- Hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics;
- Concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin;
- A history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin.
- Impaired renal function,Creatinine ≥221umol/L；
- Pregnant or breast feeding females.
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 |
|---|---|---|
| ClarithromycinAlso: Abbott- 56268, Biaxin, CLARITH500mg orally daily on days 1-28,repeated every 28 days | Drug | BiCTd regimen |
| ThalidomideAlso: Distaval, ThalomidThalidomide 100-200mg orally per night on days 1-28,repeated every 28 days | Drug | BiCTd regimen, CTd regimen |
| CyclophosphamideAlso: Endoxan, Cytoxan, Neosar, Procytox300mg/m^2 intravenously daily on day 1-3,repeated every 28 days | Drug | BiCTd regimen, CTd regimen |
| DexamethasoneAlso: Decadron, Aeroseb-Dex, Decaderm, DM40 mg orally weekly on days 1,8,15,22,repeated every 28 days | Drug | BiCTd regimen, CTd regimen |
Primary outcome
Percentage of Participants With Very Good Partial Remission (VGPR) or Better
Time frame: up to 4 months
Quality of response: % Complete Response (CR) + Very Good Partial Remission (VGPR) to induction BiCTd or CTd as assessed using International Myeloma Working Group Response Definitions. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.
3 secondary outcomes
Median Progression Free Survival (PFS) in months
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 Months
2 Year Overall Survival (OS) Rate
Time frame: up to 24 months
Number of participants with adverse events
Time frame: up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
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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.
Yongping Zhai, doctor study chair
Jinling 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 3 study testing Clarithromycin, Thalidomide and Cyclophosphamide in people with Multiple Myeloma, run by Jinling 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 6 inclusion and 6 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 6 Sep 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongping Zhai, doctor (13951947646, ypzhai@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Very Good Partial Remission (VGPR) or Better (time frame: up to 4 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 6 Sep 2017.