Acute Myelogenous LeukemiaNCT00789256
Low Dose Melphalan and Bortezomib for AML and High-Risk MDS
A study testing Melphalan, Bortezomib and Melphalan and bortezomib in people with Acute Myelogenous Leukemia and Myelodysplastic Syndromes, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to determine the response rate of the combination of bortezomib and melphalan in patients with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic Syndromes (MDS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myelogenous Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Melphalan, Bortezomib and Melphalan and bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2004to Dec 2008
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathologic diagnosis of AML or high-risk MDS Patients with chronic myelomonocytic leukemia or a refractory cytopenia with multilineage dysplasia are eligible if that have one of the following criteria:
- >4 units of red blood cells transfused during the previous 3 months
- platelet count <50,000/uL
- absolute neutrophil count <1000/uL and a recent infection requiring antibiotics
- Patients may either be considered to be poor candidates for standard induction chemotherapy based on reasonable medical evidence or have declined such therapy, but still desire palliative treatment beyond that of best supportive care
- Primary refractory disease or have disease that has relapsed after prior cytoxic therapy
Show all 19Show fewer
- Karnofsky performance status of >50%
- Patients may receive prior growth factor therapy
- Patients who received prior therapies (ex. melphalan, 5-azacitidine, low-dose cytarabine) to control their MDS or AML prior to registration (Stratum 2), but are clearly nonresponders are eligible for enrollment if expected toxicity of the prior therapy has resolved
- Voluntary written informed consent
- If female, the subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
- If male, the subject agrees to use an acceptable method for contraception for the duration of the study
- Patients that have been previously treated will be eligible for study if:
- the previous therapy was ineffective and
- all expected toxicity of the previous treatment has resolved
- In general the following guidelines regarding the elapsed time from previous treatment to eligibility should be followed
- High intensity cytotoxic treatment (7\&3 induction, High Dose Ara-C): 4 weeks
- Hematopoeitic growth factors: no delay required
- Low intensity treatment (such as oral melphalan or hydrea, low dose cytarabine or 5-azacitidine) No delay required if expected toxicity has resolved and regimen ineffective
Who cannot join
- AML FAB M3
- No concomitant malignancy other than a curatively treated carcinoma in situ of cervix or basal or squamous cell carcinoma of the skin
- Active, uncontrolled infections
- Chronic liver disease not due to AML, or bilirubin >2.0mg/dL
- End stage kidney disease on dialysis
- Active CNS disease. A lumbar puncture prior to treatment is not required and should not be performed in the absence of significant CNS symptoms or signs
Show all 10Show fewer
- Patient has sensory peripheral neuropathy > grade 2 or painful peripheral neuropathy > grade 1 (see appendix A for NCI sensory neuropathy toxicity criteria) within 14 days before enrollment
- Hypersensitivity to bortezomib, boron or mannitol
- Female subject is pregnant or breast-feeding. 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 post-menopausal or surgically sterilized women
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Integrated Community Oncology Network
Jacksonville, Florida, 32256
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Pilot Study of Low Dose Melphalan and Bortezomib for Treatment of Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndromes
The purpose of this study is to determine the response rate of the combination of bortezomib and melphalan in patients with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic Syndromes (MDS).
Read the detailed description
In patients who develop acute myelogenous leukemia (AML) or a high-risk myelodysplastic syndrome (MDS), the current standard treatment involves multidrug induction chemotherapy utilizing an anthracycline or anthraquinone with cytarabine. While chemotherapy has proven effective at inducing remission in up to 90% of patients, elderly patients fair far worse. In patients over the age of sixty, the disease is not only less responsive to therapy, but an increased number of comorbid conditions makes induction therapy a more dangerous endeavor. Because of this, many patients are not offered standard induction chemotherapy and there is a dearth of viable alternatives for treatment of these otherwise fatal diseases.
Low dose melphalan has previously been shown to be an effective palliative treatment for patients diagnosed with AML and high-risk MDS. It was found to have an overall response rate of 40% in AML patients (30% complete remission and 10% partial remission) and a 57% overall response in high-risk MDS patients (33% complete remission, 5% partial remission, and 19% minor responses). This therapy, while not curative, is one of the few options for patients unable to tolerate more intensive treatment regimens, but desiring a potentially effective palliative regimen.
Bortezomib (VELCADE®) is an intravenously administered reversible, selective inhibitor of the 26S proteosome. Although all of the mechanisms by which this novel drug acts as an antineoplastic agent are not fully understood, in vivo and in vitro studies indicate they ultimately result in the inhibition of the gene expression necessary for cell growth and survival pathways, apoptotic pathways, and cellular adhesion, migration, and angiogenesis mechanisms.
Preclinical and clinical evaluation of the combination of melphalan and bortezomib has demonstrated impressive synergy in refractory multiple myeloma cell lines and patients with myeloma. This study aims to determine if these findings hold true in AML and MDS patients.
- Being tested
- Melphalan, Bortezomib, Melphalan and bortezomib
- Keywords
- Acute Myelogenous Leukemia, AML, Myelodysplastic Syndromes, MDS, Melphalan, Bortezomib, Velcade
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
Also called Velcade
Melphalan: 2mg orally, once daily
BortezomibDrug
Bortezomib: 1.0mg/M2 IV on days 1, 4, 8, 11
Melphalan and bortezomibDrug
| Study group | Role | What they receive |
|---|---|---|
| Study treatment | Experimental | All patients will receive the following regimen: 1) Melphalan 2 mg orally, once daily. 2) Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11. Receives: Drug: Melphalan; Drug: Bortezomib; Drug: Melphalan and bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate of the Combination of Bortezomib and Melphalan in Patients With AML and High-risk MDS.
Determine disease response to treatment using Cheson 2000 report of an international working group to standardize response criteria for myelodysplastic syndromes.
Measured: Post Cycle 1 through 28 days post-treatment
Secondary outcomes (2)
Determine Safety Profile of the Combination of Bortezomib and Melphalan.
The safety profile is based on the number of adverse events experienced by participants as reported in the Adverse Events results section for this protocol.
Measured: Start of treatment through 28 days post-treatment
Number of Participants With Correlation Between in Vitro and in Vivo Activity of the Combination of Bortezomib and Melphalan.
Leukemic cells will be collected to test the presence of the study drugs using a cell viability assay in vitro and in vivo.
Measured: Pre-treatment and at complete response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startSep 2004
- Primary completionDec 2008
- Study completionDec 2008
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 (23)Papers the sponsor has linked to this study.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Marc Gautier, Dartmouth-Hitchcock Medical Center
- Investigators
- Marc Gautier, MD, Principal investigator, Dartmouth-Hitchcock Medical CenterJeffrey Bubis, DO, Principal investigator, Integrated Community Oncology Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789256
- Sponsor's protocol ID
- D0337
- Status last verified
- Oct 2018
- First submitted
- 6 Oct 2008
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Phillips GL, Reece DE, Shepherd JD, Barnett MJ, Brown RA, Frei-Lahr DA, Klingemann HG, Bolwell BJ, Spinelli JJ, Herzig RH, et al. High-dose cytarabine and daunorubicin induction and postremission chemotherapy for the treatment of acute myelogenous leukemia in adults. Blood. 1991 Apr 1;77(7):1429-35.
PubMed 2009367Johnson PR, Yin JA. Prognostic factors in elderly patients with acute myeloid leukaemia. Leuk Lymphoma. 1994 Dec;16(1-2):51-6. doi: 10.3109/10428199409114139.
PubMed 7696931Maslak PG, Weiss MA, Berman E, Yao TJ, Tyson D, Golde DW, Scheinberg DA. Granulocyte colony-stimulating factor following chemotherapy in elderly patients with newly diagnosed acute myelogenous leukemia. Leukemia. 1996 Jan;10(1):32-9.
PubMed 8558934Leith CP, Kopecky KJ, Godwin J, McConnell T, Slovak ML, Chen IM, Head DR, Appelbaum FR, Willman CL. Acute myeloid leukemia in the elderly: assessment of multidrug resistance (MDR1) and cytogenetics distinguishes biologic subgroups with remarkably distinct responses to standard chemotherapy. A Southwest Oncology Group study. Blood. 1997 May 1;89(9):3323-9.
PubMed 9129038Denzlinger C, Bowen D, Benz D, Gelly K, Brugger W, Kanz L. Low-dose melphalan induces favourable responses in elderly patients with high-risk myelodysplastic syndromes or secondary acute myeloid leukaemia. Br J Haematol. 2000 Jan;108(1):93-5. doi: 10.1046/j.1365-2141.2000.01825.x.
PubMed 10651730Omoto E, Deguchi S, Takaba S, Kojima K, Yano T, Katayama Y, Sunami K, Takeuchi M, Kimura F, Harada M, Kimura I. Low-dose melphalan for treatment of high-risk myelodysplastic syndromes. Leukemia. 1996 Apr;10(4):609-14.
PubMed 8618435Mitchell BS. The proteasome--an emerging therapeutic target in cancer. N Engl J Med. 2003 Jun 26;348(26):2597-8. doi: 10.1056/NEJMp030092. No abstract available.
PubMed 12826633King RW, Deshaies RJ, Peters JM, Kirschner MW. How proteolysis drives the cell cycle. Science. 1996 Dec 6;274(5293):1652-9. doi: 10.1126/science.274.5293.1652.
PubMed 8939846Karin M, Cao Y, Greten FR, Li ZW. NF-kappaB in cancer: from innocent bystander to major culprit. Nat Rev Cancer. 2002 Apr;2(4):301-10. doi: 10.1038/nrc780.
PubMed 12001991Haefner B. NF-kappa B: arresting a major culprit in cancer. Drug Discov Today. 2002 Jun 15;7(12):653-63. doi: 10.1016/s1359-6446(02)02309-7.
PubMed 12110242Dokter WH, Tuyt L, Sierdsema SJ, Esselink MT, Vellenga E. The spontaneous expression of interleukin-1 beta and interleukin-6 is associated with spontaneous expression of AP-1 and NF-kappa B transcription factor in acute myeloblastic leukemia cells. Leukemia. 1995 Mar;9(3):425-32.
PubMed 7885041Felix CA. Secondary leukemias induced by topoisomerase-targeted drugs. Biochim Biophys Acta. 1998 Oct 1;1400(1-3):233-55. doi: 10.1016/s0167-4781(98)00139-0.
PubMed 9748598Chernov MV, Bean LJ, Lerner N, Stark GR. Regulation of ubiquitination and degradation of p53 in unstressed cells through C-terminal phosphorylation. J Biol Chem. 2001 Aug 24;276(34):31819-24. doi: 10.1074/jbc.M103170200. Epub 2001 Jun 28.
PubMed 11431470Olsson I, Bergh G, Ehinger M, Gullberg U. Cell differentiation in acute myeloid leukemia. Eur J Haematol. 1996 Jul;57(1):1-16. doi: 10.1111/j.1600-0609.1996.tb00483.x.
PubMed 8698118Padua RA, Guinn BA, Al-Sabah AI, Smith M, Taylor C, Pettersson T, Ridge S, Carter G, White D, Oscier D, Chevret S, West R. RAS, FMS and p53 mutations and poor clinical outcome in myelodysplasias: a 10-year follow-up. Leukemia. 1998 Jun;12(6):887-92. doi: 10.1038/sj.leu.2401044.
PubMed 9639416
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Low Dose Melphalan and Bortezomib for Treatment of Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00789256
- Acronym / sponsor ID
- D0337
- Keywords
- Acute Myelogenous Leukemia, AML, Myelodysplastic Syndromes, MDS, Melphalan, Bortezomib, Velcade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Sep 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Nov 2008 (estimated)
- Results
- Posted 22 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the response rate of the combination of bortezomib and melphalan in patients with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic Syndromes (MDS).
Detailed description
In patients who develop acute myelogenous leukemia (AML) or a high-risk myelodysplastic syndrome (MDS), the current standard treatment involves multidrug induction chemotherapy utilizing an anthracycline or anthraquinone with cytarabine. While chemotherapy has proven effective at inducing remission in up to 90% of patients, elderly patients fair far worse. In patients over the age of sixty, the disease is not only less responsive to therapy, but an increased number of comorbid conditions makes induction therapy a more dangerous endeavor. Because of this, many patients are not offered standard induction chemotherapy and there is a dearth of viable alternatives for treatment of these otherwise fatal diseases.
Low dose melphalan has previously been shown to be an effective palliative treatment for patients diagnosed with AML and high-risk MDS. It was found to have an overall response rate of 40% in AML patients (30% complete remission and 10% partial remission) and a 57% overall response in high-risk MDS patients (33% complete remission, 5% partial remission, and 19% minor responses). This therapy, while not curative, is one of the few options for patients unable to tolerate more intensive treatment regimens, but desiring a potentially effective palliative regimen.
Bortezomib (VELCADE®) is an intravenously administered reversible, selective inhibitor of the 26S proteosome. Although all of the mechanisms by which this novel drug acts as an antineoplastic agent are not fully understood, in vivo and in vitro studies indicate they ultimately result in the inhibition of the gene expression necessary for cell growth and survival pathways, apoptotic pathways, and cellular adhesion, migration, and angiogenesis mechanisms.
Preclinical and clinical evaluation of the combination of melphalan and bortezomib has demonstrated impressive synergy in refractory multiple myeloma cell lines and patients with myeloma. This study aims to determine if these findings hold true in AML and MDS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study treatment | Experimental | Drug: Melphalan, Drug: Bortezomib, Drug: Melphalan and bortezomibAll patients will receive the following regimen: 1) Melphalan 2 mg orally, once daily. 2) Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Pathologic diagnosis of AML or high-risk MDS Patients with chronic myelomonocytic leukemia or a refractory cytopenia with multilineage dysplasia are eligible if that have one of the following criteria:
- Patients may either be considered to be poor candidates for standard induction chemotherapy based on reasonable medical evidence or have declined such therapy, but still desire palliative treatment beyond that of best supportive care
- Primary refractory disease or have disease that has relapsed after prior cytoxic therapy
- Karnofsky performance status of >50%
- Patients may receive prior growth factor therapy
Key exclusion criteria (10 listed)
- AML FAB M3
- No concomitant malignancy other than a curatively treated carcinoma in situ of cervix or basal or squamous cell carcinoma of the skin
- Active, uncontrolled infections
- Chronic liver disease not due to AML, or bilirubin >2.0mg/dL
- End stage kidney disease on dialysis
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 |
|---|---|---|
| MelphalanAlso: VelcadeMelphalan: 2mg orally, once daily | Drug | Study treatment |
| BortezomibBortezomib: 1.0mg/M2 IV on days 1, 4, 8, 11 | Drug | Study treatment |
| Melphalan and bortezomib | Drug | Study treatment |
Primary outcome
Response Rate of the Combination of Bortezomib and Melphalan in Patients With AML and High-risk MDS.
Time frame: Post Cycle 1 through 28 days post-treatment
Determine disease response to treatment using Cheson 2000 report of an international working group to standardize response criteria for myelodysplastic syndromes.
2 secondary outcomes
Determine Safety Profile of the Combination of Bortezomib and Melphalan.
Time frame: Start of treatment through 28 days post-treatment
Number of Participants With Correlation Between in Vitro and in Vivo Activity of the Combination of Bortezomib and Melphalan.
Time frame: Pre-treatment and at complete response
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2009367Phillips GL, Reece DE, Shepherd JD, Barnett MJ, Brown RA, Frei-Lahr DA, Klingemann HG, Bolwell BJ, Spinelli JJ, Herzig RH, et al. High-dose cytarabine and daunorubicin induction and postremission chemotherapy for the treatment of acute myelogenous leukemia in adults. Blood. 1991 Apr 1;77(7):1429-35.
- Background: PubMed 7696931Johnson PR, Yin JA. Prognostic factors in elderly patients with acute myeloid leukaemia. Leuk Lymphoma. 1994 Dec;16(1-2):51-6. doi: 10.3109/10428199409114139.
- Background: PubMed 8558934Maslak PG, Weiss MA, Berman E, Yao TJ, Tyson D, Golde DW, Scheinberg DA. Granulocyte colony-stimulating factor following chemotherapy in elderly patients with newly diagnosed acute myelogenous leukemia. Leukemia. 1996 Jan;10(1):32-9.
- Background: PubMed 9129038Leith CP, Kopecky KJ, Godwin J, McConnell T, Slovak ML, Chen IM, Head DR, Appelbaum FR, Willman CL. Acute myeloid leukemia in the elderly: assessment of multidrug resistance (MDR1) and cytogenetics distinguishes biologic subgroups with remarkably distinct responses to standard chemotherapy. A Southwest Oncology Group study. Blood. 1997 May 1;89(9):3323-9.
- Background: PubMed 10651730Denzlinger C, Bowen D, Benz D, Gelly K, Brugger W, Kanz L. Low-dose melphalan induces favourable responses in elderly patients with high-risk myelodysplastic syndromes or secondary acute myeloid leukaemia. Br J Haematol. 2000 Jan;108(1):93-5. doi: 10.1046/j.1365-2141.2000.01825.x.
- Background: PubMed 8618435Omoto E, Deguchi S, Takaba S, Kojima K, Yano T, Katayama Y, Sunami K, Takeuchi M, Kimura F, Harada M, Kimura I. Low-dose melphalan for treatment of high-risk myelodysplastic syndromes. Leukemia. 1996 Apr;10(4):609-14.
- Background: PubMed 12826633Mitchell BS. The proteasome--an emerging therapeutic target in cancer. N Engl J Med. 2003 Jun 26;348(26):2597-8. doi: 10.1056/NEJMp030092. No abstract available.
- Background: PubMed 8939846King RW, Deshaies RJ, Peters JM, Kirschner MW. How proteolysis drives the cell cycle. Science. 1996 Dec 6;274(5293):1652-9. doi: 10.1126/science.274.5293.1652.
- Background: PubMed 12001991Karin M, Cao Y, Greten FR, Li ZW. NF-kappaB in cancer: from innocent bystander to major culprit. Nat Rev Cancer. 2002 Apr;2(4):301-10. doi: 10.1038/nrc780.
- Background: PubMed 12110242Haefner B. NF-kappa B: arresting a major culprit in cancer. Drug Discov Today. 2002 Jun 15;7(12):653-63. doi: 10.1016/s1359-6446(02)02309-7.
- Background: PubMed 7885041Dokter WH, Tuyt L, Sierdsema SJ, Esselink MT, Vellenga E. The spontaneous expression of interleukin-1 beta and interleukin-6 is associated with spontaneous expression of AP-1 and NF-kappa B transcription factor in acute myeloblastic leukemia cells. Leukemia. 1995 Mar;9(3):425-32.
- Background: PubMed 9748598Felix CA. Secondary leukemias induced by topoisomerase-targeted drugs. Biochim Biophys Acta. 1998 Oct 1;1400(1-3):233-55. doi: 10.1016/s0167-4781(98)00139-0.
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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.
Marc Gautier, MD principal investigator
Dartmouth-Hitchcock Medical Center
Jeffrey Bubis, DO principal investigator
Integrated Community Oncology Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melphalan, Bortezomib and Melphalan and bortezomib in people with Acute Myelogenous Leukemia and Myelodysplastic Syndromes, run by Dartmouth-Hitchcock Medical Center at 2 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 19 inclusion and 10 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 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2013). 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 of the Combination of Bortezomib and Melphalan in Patients With AML and High-risk MDS. (time frame: Post Cycle 1 through 28 days post-treatment). 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 NCT00789256, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.