Multiple MyelomaPhase 2NCT01438177
Chloroquine in Combination With VELCADE and Cyclophosphamide for Relapsed and Refractory Multiple Myeloma
A Phase 2 study testing Velcade, Cyclophosphamide and Chloroquine in people with Multiple Myeloma, run by NYU Langone Health at 1 site in United States.
Trial summary
This pilot phase II trial studies how well giving bortezomib and cyclophosphamide together with chloroquine works in treating patients with relapsed or refractory multiple myeloma. 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?
- Velcade, Cyclophosphamide and Chloroquine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Feb 2014
- Phase
- Phase 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
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of VELCADE, or agree to completely abstain from heterosexual intercourse. Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
- Diagnosis of multiple myeloma based on standard criteria as follows:
- Major Criteria:
- Plasmacytomas on tissue biopsy
- Bone marrow plasmacytosis (>30% plasma cells)
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- Monoclonal immunoglobulin spike on serum electrophoresis (IgG >3.5 G/dL or IgA > 2.0 G/dL) or kappa or lambda light chain excretion> 1 G/day on 24 hour urine protein electrophoresis
- Minor Criteria
- Bone marrow plasmacytosis (10 to 30% plasma cells)
- Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
- Lytic bone lesions
- Normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL
- Any of the following sets of criteria will confirm the diagnosis of Multiple Myeloma:
- Any two of the major criteria
- Major criterion I plus minor criterion b, c, or d
- Major criterion III plus minor criterion a or c
- Minor criteria a, b and c or a, b and d
- Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of ≥ 1 Gm/dL and/or urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours.
- Patients must have refractory myeloma as defined by a greater than 25% increase in their M-protein. They should have progressed on a combination of VELCADE and cyclophosphamide.
- Non-secretors must have measurable protein by Freelite or measurable disease such as plasmacytoma to be eligible.
- Karnofsky performance status ≥ 50
- Patients treated with local radiotherapy with or without a brief exposure to steroids are eligible. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed
- Meets the following pretreatment laboratory criteria at Baseline (Day 1 of Cycle 1, before study drug administration)
- Absolute neutrophil count ≥ 0.5 x 10^3/uL
- Calculated or measured creatinine clearance ≥ 30 mL/min
- Age 18 years or older
Who cannot join
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
- Plasma cell leukemia
- Receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
- Infection not controlled by antibiotics
- HIV infection. Patients should provide consent for HIV testing according to the institution's standard practice
- Known active hepatitis B or C
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- Patient had myocardial infarction within 6 months prior to enrollment, New York Hospital Association (NYHA) Class III or IV heart failure, (see appendix D), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
- Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
- Female subject is pregnant or lactating. Confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women.
- Patient has > Grade 2 peripheral neuropathy
- Patient has known hypersensitivity to VELCADE, boron or mannitol, quinidine or quinidine derivatives or to cyclophosphamide or any component of the formulation.
- Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
- Patients with preexisting retinal or visual field changes.
- Patient has > 1.5 x upper limit of normal Total Bilirubin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Trial of Chloroquine in Combination With VELCADE and Cyclophosphamide in Patients With Relapsed and Refractory Myeloma
This pilot phase II trial studies how well giving bortezomib and cyclophosphamide together with chloroquine works in treating patients with relapsed or refractory multiple myeloma.
Read the detailed description
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chloroquine may help chemotherapy drugs work better by making cancer cells more sensitive to the drug. Giving bortezomib and cyclophosphamide together with chloroquine may kill more cancer cells.
- Conditions
- Multiple Myeloma
- Being tested
- Velcade, Cyclophosphamide, Chloroquine
- Keywords
- myeloma, multiple myeloma, relapsed myeloma, refractory myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelcadeDrug
Also called Bendamustine HCl, Treanda, Bortezomib
CyclophosphamideDrug
Also called Cytoxan, Neosar, Endoxan, Revimmune
ChloroquineDrug
Also called Aralen
| Study group | Role | What they receive |
|---|---|---|
| Velcade+Cyclophosphamide+Chloroquine | Experimental | VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.
Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.
Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.
Each cycle is 42 days in length. Receives: Drug: Velcade; Drug: Cyclophosphamide; Drug: Chloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (CR + PR After 2 Cycles)
Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria:
CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h
Measured: Up to 2 years
Secondary outcomes (3)
Number of Participants With Adverse Events of Grade 3 or Higher
Adverse events reported here were at least possibly related to the protocol therapy.
Measured: Treatment period plus 30 days post-treatment
Percentage of Subjects Who Have Complete Response or Partial Response and Have 2+ or Higher Autophagy
Measured: until clinical response (up to 2 years)
Median Duration of Response of This Regimen
Duration of response is the time from response (CR or PR) until progression of disease or relapse. Responses and progression were evaluated based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006).
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: PI left institution.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Grossbard, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438177
- Sponsor's protocol ID
- 10-02008
- Status last verified
- Feb 2020
- First submitted
- 8 Sep 2011
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Durie BG, Harousseau JL, Miguel JS, Blade J, Barlogie B, Anderson K, Gertz M, Dimopoulos M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M, Crowley J, Belch A, Boccadaro M, Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, Powles R, Richardson P, Shimizu K, Tosi P, Morgan G, Rajkumar SV; International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia. 2006 Sep;20(9):1467-73. doi: 10.1038/sj.leu.2404284. Epub 2006 Jul 20.
PubMed 16855634
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Trial of Chloroquine in Combination With VELCADE and Cyclophosphamide in Patients With Relapsed and Refractory Myeloma
- ClinicalTrials.gov ID
- NCT01438177
- Acronym / sponsor ID
- 10-02008
- Conditions
- Multiple Myeloma
- Keywords
- myeloma, multiple myeloma, relapsed myeloma, refractory myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Posted 1 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot phase II trial studies how well giving bortezomib and cyclophosphamide together with chloroquine works in treating patients with relapsed or refractory multiple myeloma.
Detailed description
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chloroquine may help chemotherapy drugs work better by making cancer cells more sensitive to the drug. Giving bortezomib and cyclophosphamide together with chloroquine may kill more cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Velcade+Cyclophosphamide+Chloroquine | Experimental | Drug: Velcade, Drug: Cyclophosphamide, Drug: ChloroquineVELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32. Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35. Chloroquine given at 500 mg orally daily on days 1-14 and 22-35. Each cycle is 42 days in length. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of VELCADE, or agree to completely abstain from heterosexual intercourse. Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
- Diagnosis of multiple myeloma based on standard criteria as follows:
- Minor Criteria
- Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of ≥ 1 Gm/dL and/or urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours.
Key exclusion criteria (16 listed)
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
- Plasma cell leukemia
- Receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
- Infection not controlled by antibiotics
- HIV infection. Patients should provide consent for HIV testing according to the institution's standard practice
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 |
|---|---|---|
| VelcadeAlso: Bendamustine HCl, Treanda, Bortezomib | Drug | Velcade+Cyclophosphamide+Chloroquine |
| CyclophosphamideAlso: Cytoxan, Neosar, Endoxan, Revimmune | Drug | Velcade+Cyclophosphamide+Chloroquine |
| ChloroquineAlso: Aralen | Drug | Velcade+Cyclophosphamide+Chloroquine |
Primary outcome
Response Rate (CR + PR After 2 Cycles)
Time frame: Up to 2 years
Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria: CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h
3 secondary outcomes
Number of Participants With Adverse Events of Grade 3 or Higher
Time frame: Treatment period plus 30 days post-treatment
Percentage of Subjects Who Have Complete Response or Partial Response and Have 2+ or Higher Autophagy
Time frame: until clinical response (up to 2 years)
Median Duration of Response of This Regimen
Time frame: up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16855634Durie BG, Harousseau JL, Miguel JS, Blade J, Barlogie B, Anderson K, Gertz M, Dimopoulos M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M, Crowley J, Belch A, Boccadaro M, Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, Powles R, Richardson P, Shimizu K, Tosi P, Morgan G, Rajkumar SV; International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia. 2006 Sep;20(9):1467-73. doi: 10.1038/sj.leu.2404284. Epub 2006 Jul 20.
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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.
Michael Grossbard, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Velcade, Cyclophosphamide and Chloroquine in people with Multiple Myeloma, run by NYU Langone Health at 1 site 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 26 inclusion and 16 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: stopped early, as of the sponsor's last update on 24 Feb 2020. 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 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 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?
Yes. Results are posted in the registry (first posted 1 Jun 2015). 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?
Response Rate (CR + PR After 2 Cycles) (time frame: Up to 2 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 NCT01438177, 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 24 Feb 2020.