Multiple MyelomaPhase 1/2NCT01057225
Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma
A Phase 1/2 study testing carfilzomib, cyclophosphamide and thalidomide in people with Multiple Myeloma and Stage I Multiple Myeloma, run by Mayo Clinic at 3 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma
- What is being tested?
- carfilzomib, cyclophosphamide and thalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2010to 5 Sep 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Creatinine =< 2 mg/dL
- Calculated Creatinine Clearance >= 30 mL/min
- Total Bilirubin =< 2.0 mg/dL
- Alkaline Phosphatase =< 3 x ULN
- ALT =< 3 x ULN
- Absolute neutrophil count >= 1000/uL
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- Platelet >= 75000/uL
- Hemoglobin >= 8.0 g/dL
- Untreated symptomatic myeloma: Prior non-systemic therapy for the treatment of solitary plasmacytoma is permitted, but >= 1 month should have elapsed from the last day of radiation; prior therapy with clarithromycin, DHEA, anakinra, pamidronate or zoledronic acid is permitted; any additional agents not listed must be approved by the Principal Investigator
- Prior high dose corticosteroid therapy for twelve days (480 mg total dose) or less is permitted for emergent complications from newly diagnosed multiple myeloma
- Measurable disease of multiple myeloma, as defined by at least ONE of the following:
- Serum monoclonal protein >= 1.0 g by protein electrophoresis
- OR > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- OR serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio; OR monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
- ECOG performance status (PS) 0, 1, 2; ECOG PS of 3 will be allowed if secondary to pain in the opinion of the Investigator
- Willingness and able to provide informed written consent
- Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- Willingness to return to Mayo Clinic enrolling institution for follow-up
Who cannot join
- MGUS or smoldering myeloma
- Peripheral sensory neuropathy >= Grade 2 as defined by CTEP Active Version of the CTCAE
- Active malignancy with the exception of non melanoma skin cancer or in situ cervical or breast cancer
- Pregnant women or women of reproductive ability who are unwilling to use effective contraception
- Nursing women
- Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment
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- Known hypersensitivity, allergy or inability to tolerate any of the agents employed
- Active, uncontrolled infection
- Severe cardiac comorbidity
- New York Heart Association Class III or IV Heart Failure
- Recent history of myocardial infarction in the six months prior to registration
- Uncontrolled angina or electrocardiographic evidence of acute ischemia
- Severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of active conduction system abnormalities
- Cardiac amyloidosis with hypotension (systolic BP less than 100 mmHg)
- Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
- The following medications are not permitted during the trial: any other investigational treatment; any cytotoxic chemotherapy; any other systemic anti-neoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy
- Palliative radiation therapy is permitted if clinically indicated and not indicative of progressive disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425-6350
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: A Phase I/II Trial of Cyclophosphamide, Carfilzomib, Thalidomide and Dexamethasone (CYCLONE) in Patients With Newly Diagnosed Active Multiple Myeloma
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone in treating patients with newly diagnosed active multiple myeloma.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. (Phase I) II. In newly diagnosed myeloma to evaluate the response rate (CR, nCR, and VGPR) to carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone after four 28 day cycles. (Phase II)
SECONDARY OBJECTIVES:
- Determine the overall response rate (CR, nCR, PR) after 4, 8, 12 cycles. II. Determine the duration of progression-free and overall survival for patients receiving this regimen.
III. To evaluate the incidence of toxicities for this regimen. IV. To evaluate the ability to successfully collect peripheral blood stem cells following four months of combination therapy.
OUTLINE: This is a phase I, dose escalation study of carfilzomib followed by a phase II study.
Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months, then every 3 months for 1 year, and then every 6 months for up to 3 years.
- Conditions
- Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- Being tested
- carfilzomib, cyclophosphamide, thalidomide, dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carfilzomibDrug
Also called PR-171
Given IV
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
Given orally
thalidomideDrug
Also called alpha-phthalimidoglutarimide, Contergan, Kevadon, Synovir
Given orally
dexamethasoneDrug
Also called Aeroseb-Dex, Decaderm, Decadron, Decaspray
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28. Receives: Drug: carfilzomib; Drug: cyclophosphamide; Drug: thalidomide; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (Phase I)
To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone.
For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2.
We are reporting the number of DLTs
Measured: From baseline to end of active treatment, up to 12 28-day cycles.
Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II)
The proportion of patients who have at least a confirmed very good partial response will be calculated by taking the number of patients with a very good partial response or a complete response divided by the total number of patients.
A complete response is defined as:
- Negative immunofixation of the serum and urine
- If at on study, only the measurable non-bone marrow parameter was FLC, normalization of FLC ratio
- < 5% plasma cells in bone marrow
- Disappearance of any soft tissue plasmacytomas
A very good partial response is defined as:
- Serum and urine M-component detectable by immunofixation but not on electrophoresis or
- If at on study, serum measurable, ≥ 90% or greater reduction in serum Mcomponent
- Urine M-component <100 mg per 24 hour
Measured: Following the first 4 cycles of treatment (28 day cycles)
Secondary outcomes (9)
Progression-free Survival (Phase II)
PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following:
- Increase of 25% from lowest confirmed response in: Serum M-component (absolute increase must be ≥ 0.5 g/dl)c Urine M-component (absolute increase must be ≥ 200 mg/24 hour) If at on study, only the measurable non-bone marrow parameter was FLC, the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl) Bone marrow plasma cell percentage (absolute % must be 10%)d Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
- Development of hypercalcemia (corrected serum calcium >11.5 mg/dl) that can be attributed solely to the plasma cell proliferative disorder
Measured: From baseline to progression or death up to 3 years
Time to Treatment Failure
The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier
Measured: From baseline to end of active treatment
Stem Cell Collection and Engraftment (Phase II)
For patients going on to stem cell collection, the total number of CD34 positive cells collected per collection, days to platelets over 20,000 without transfusion and ANC over 1000 will be recorded. If a patient fails to collect adequate stem cells for transplant, this will be recorded as such. The number of patients with successful stem cell mobilization are reported.
Measured: Following the first 4 courses of treatment
Complete Response (Phase II)
In patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy.
Measured: Following the first 4 courses of treatment
Survival Time (Phase II)
Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier
Measured: From baseline to death
Progression Free Survival (12 Month)
Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 12 month mark.
Measured: 12 months
Progession Free Survival (24 Month)
Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 24 month mark.
Measured: 24 months
Overall Survival (12 Month)
12 Month Overall survival is defined as the proportion of patients to still be alive after 12 months.
Measured: From baseline to death
Overall Survival (24 Month)
24 Month Overall survival is defined as the proportion of patients to still be alive after 24 months.
Measured: From baseline to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2014
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph R. Mikhael, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057225
- Sponsor's protocol ID
- MC0982
- Other IDs
- NCI-2009-01699, PT-171-502, 09-004091, MC0982
- Status last verified
- Nov 2017
- First submitted
- 26 Jan 2010
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Cyclophosphamide, Carfilzomib, Thalidomide and Dexamethasone (CYCLONE) in Patients With Newly Diagnosed Active Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01057225
- Acronym / sponsor ID
- MC0982
- Conditions
- Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Posted 23 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone in treating patients with newly diagnosed active multiple myeloma.
Detailed description
PRIMARY OBJECTIVES:
- To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. (Phase I) II. In newly diagnosed myeloma to evaluate the response rate (CR, nCR, and VGPR) to carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone after four 28 day cycles. (Phase II)
SECONDARY OBJECTIVES:
- Determine the overall response rate (CR, nCR, PR) after 4, 8, 12 cycles. II. Determine the duration of progression-free and overall survival for patients receiving this regimen.
III. To evaluate the incidence of toxicities for this regimen. IV. To evaluate the ability to successfully collect peripheral blood stem cells following four months of combination therapy.
OUTLINE: This is a phase I, dose escalation study of carfilzomib followed by a phase II study.
Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months, then every 3 months for 1 year, and then every 6 months for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: carfilzomib, Drug: cyclophosphamide, Drug: thalidomide, Drug: dexamethasonePatients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Creatinine =< 2 mg/dL
- Calculated Creatinine Clearance >= 30 mL/min
- Total Bilirubin =< 2.0 mg/dL
- Alkaline Phosphatase =< 3 x ULN
- ALT =< 3 x ULN
Key exclusion criteria (17 listed)
- MGUS or smoldering myeloma
- Peripheral sensory neuropathy >= Grade 2 as defined by CTEP Active Version of the CTCAE
- Active malignancy with the exception of non melanoma skin cancer or in situ cervical or breast cancer
- Pregnant women or women of reproductive ability who are unwilling to use effective contraception
- Nursing women
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 |
|---|---|---|
| carfilzomibAlso: PR-171Given IV | Drug | Arm I |
| cyclophosphamideAlso: CPM, CTX, Cytoxan, EndoxanGiven orally | Drug | Arm I |
| thalidomideAlso: alpha-phthalimidoglutarimide, Contergan, Kevadon, SynovirGiven orally | Drug | Arm I |
| dexamethasoneAlso: Aeroseb-Dex, Decaderm, Decadron, DecasprayGiven orally | Drug | Arm I |
Primary outcome
Maximum Tolerated Dose (Phase I)
Time frame: From baseline to end of active treatment, up to 12 28-day cycles.
To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2. We are reporting the number of DLTs
Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II)
Time frame: Following the first 4 cycles of treatment (28 day cycles)
The proportion of patients who have at least a confirmed very good partial response will be calculated by taking the number of patients with a very good partial response or a complete response divided by the total number of patients. A complete response is defined as: * Negative immunofixation of the serum and urine * If at on study, only the measurable non-bone marrow parameter was FLC, normalization of FLC ratio * < 5% plasma cells in bone marrow * Disappearance of any soft tissue plasmacytomas A very good partial response is defined as: * Serum and urine M-component detectable by immunofixation but not on electrophoresis or * If at on study, serum measurable, ≥ 90% or greater reduction in serum Mcomponent * Urine M-component <100 mg per 24 hour
9 secondary outcomes
Progression-free Survival (Phase II)
Time frame: From baseline to progression or death up to 3 years
Time to Treatment Failure
Time frame: From baseline to end of active treatment
Stem Cell Collection and Engraftment (Phase II)
Time frame: Following the first 4 courses of treatment
Complete Response (Phase II)
Time frame: Following the first 4 courses of treatment
Survival Time (Phase II)
Time frame: From baseline to death
Progression Free Survival (12 Month)
Time frame: 12 months
Progession Free Survival (24 Month)
Time frame: 24 months
Overall Survival (12 Month)
Time frame: From baseline to death
Overall Survival (24 Month)
Time frame: From baseline to death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph R. Mikhael, M.D. study chair
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing carfilzomib, cyclophosphamide and thalidomide in people with Multiple Myeloma and Stage I Multiple Myeloma, run by Mayo Clinic at 3 sites in United States.
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 18 inclusion and 17 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 23 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Tolerated Dose (Phase I) (time frame: From baseline to end of active treatment, up to 12 28-day cycles.). The study lists 2 primary outcomes in all. 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 12 Dec 2017.