Multiple MyelomaPhase 1/2DMVNCT00516191
A Phase I/II Study of Liposomal Doxorubicin (Doxil)/Melphalan/Bortezomib (Velcade) in Relapsed/Refractory Multiple Myeloma
A Phase 1/2 study testing Liposomal Doxorubicin/Melphalan/Bortezomib in people with Multiple Myeloma, run by University of California, San Francisco at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of four dose levels of liposomal doxorubicin, melphalan, and bortezomib in patients with relapsed/refractory MM and to identify a maximum tolerated dose (MTD) of this combination. 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?
- Liposomal Doxorubicin/Melphalan/Bortezomib
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Dec 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously diagnosed with multiple myeloma; Durie-Salmon Stage I, II, or III based on standard criteria
- Progressive disease, defined as 25% increase in serum M-protein or Bence Jones protein (an absolute increase of 0.5 gram/dL serum M-protein or at least 200 mg/24 hours of urine light chain excretion). For non-secretory multiple myeloma, progressive disease is defined as bone marrow biopsy with >25% increase in plasma cells or an absolute increase of at least 10% over prior known level. Alternatively, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia or relapse from CR.
- 18 year or older and willing and able to comply with the protocol requirements.
- Patient has signed informed consent.
- Unless a female patient is post-menopausal or surgically sterilized, must be willing to use an acceptable method of birth control (hormonal contraceptive, intrauterine device, diaphragm, with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male patient must agree to use an acceptable method for contraception for the duration of the study.
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- ECOG performance Status of < or equal to 2.
- Life expectancy is at least 3 months.
- Initial Required Laboratory Values within 14 days of baseline i.e. Cycle 1, Day 1 (note that renal insufficiency, including dialysis dependence is permissable):
- ANC>1,000uL without the use of colony stimulating factors
- Platelets >50,000/L without transfusion support 7 days before the test
- Bilirubin < or equal to 2.0 mg/dL
- AST < or equal to 4 x upper limit of normal
- Prior therapy: Patient must have had at least 2 prior therapeutic regimens as defined below for treatment of multiple myeloma
- Biologic therapy:
- Prior nonmyeloablative transplantation allowed provided patient does not have significant graft-versus-host disease and is off aggressive immunosuppressive therapy for at least 30 days. Low dose immunosuppression is allowed (i.e. Prednisone at dose < or equal to 10 mg daily, low dose tacrolimus (subtherapeutic levels) or other agents with equivalent low-dose immunosuppression).
- Chemotherapy:
- Mobilization with chemotherapy followed by either single or tandem autologous transplantation is counted as 1 prior regimen.
- Mobilization with chemotherapy followed by autologous and subsequent nonmyeloablative allogenic transplantation is counted as 1 prior regimen.
- Any combination of drugs given concurrently is counted as a single regimen.
Who cannot join
- Pregnant or breast-feeding
- History of allergic reaction to compounds containing boron or mannitol.
- Active uncontrolled viral (including HIV), bacterial, or fungal infection.
- Grade III or IV toxicity due to previous anti-neoplastic therapy (except alopecia).
- Grade > or equal to 2 motor or sensory neuropathy as defined by the NCI Common Toxicity Criteria (NCI CTC):
- Grade 2: Either mild objective weakness or objective sensory loss/parasthesia (including tingling) that interferes with function, but not interfering with ADLs.
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- Grade 3: Objective weakness or sensory loss/parasthesia interfering with ADLs.
- Grade 4: Paralysis or permanent sensory loss that interferes with function.
- Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia.
- For any patients whose lifetime cumulative doxorubicin dose exceeds 400 mg/m(2), patients with LVEF < or equal to 35% by MUGA are excluded. In other patients, MUGA is not required but if performed, LVEF must be > or equal to 35%.
- Concurrent administration of liposomal doxorubicin, melphalan, and bortezomib (single or two drug combinations of these are permissable).
- Less than 3 weeks since most recent chemotherapy or concurrent chemotherapy.
- Use of corticosteroids (>10 mg prednisone/day or equivalent).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
The primary objective of this study is to evaluate the safety and tolerability of four dose levels of liposomal doxorubicin, melphalan, and bortezomib in patients with relapsed/refractory MM and to identify a maximum tolerated dose (MTD) of this combination.
- Conditions
- Multiple Myeloma
- Being tested
- Liposomal Doxorubicin/Melphalan/Bortezomib
- Keywords
- Multiple Myeloma, Velcade, Doxil, Melphalan
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Doxorubicin/Melphalan/BortezomibDrug
Also called Liposomal Doxorubicin=Doxil, Melphalan=Alkeran, Bortezomib=Velcade
Day 1 Bortezomib 0.7 mg/m(2)IV + Doxil 10-20 mg/m(2)IV+Melphalan 5-10mg/m(2)IV Day 4 Bortezomib 0.7 mg/m(2)IV Day 8 Bortezomib 0.7 mg/m(2)IV Day 11 Bortezomib 0.7 mg/m(2)IV
The treatment cycles will be repeated every 28 days. Dose Level 1: Doxil 10mg/m(2), Melphalan 5 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 2: Doxil 10mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 3: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 4: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 1.0mg/m(2)
What is being measured
The primary outcome is the main question the study is designed to answer.
--To evaluate the safety and tolerability of four dose levels of liposomal doxorubicin, melphalan, and bortezomib in patients with relapsed/refractory MM and to identify a maximum tolerated dose of this combination.
Measured: 6 years
Secondary outcomes (1)
--To determine the efficacy of DMV therapy --Tabulate all the toxicities of DMV at the MTD by NCI criteria
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startOct 2004
- Primary completionOct 2010
- Study completionDec 2010
Why it stopped: low accrual
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.
- More trials run by University of California, San FranciscoThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Thomas G. Martin, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516191
- Sponsor's protocol ID
- UC-2408
- Acronym
- DMV
- Status last verified
- Mar 2015
- First submitted
- 13 Aug 2007
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Liposomal Doxorubicin (Doxil)/Melphalan/Bortezomib (Velcade) in Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00516191
- Acronym / sponsor ID
- DMV / UC-2408
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Velcade, Doxil, Melphalan
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Aug 2007 (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.
The primary objective of this study is to evaluate the safety and tolerability of four dose levels of liposomal doxorubicin, melphalan, and bortezomib in patients with relapsed/refractory MM and to identify a maximum tolerated dose (MTD) of this combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Previously diagnosed with multiple myeloma; Durie-Salmon Stage I, II, or III based on standard criteria
- Progressive disease, defined as 25% increase in serum M-protein or Bence Jones protein (an absolute increase of 0.5 gram/dL serum M-protein or at least 200 mg/24 hours of urine light chain excretion). For non-secretory multiple myeloma, progressive disease is defined as bone marrow biopsy with >25% increase in plasma cells or an absolute increase of at least 10% over prior known level. Alternatively, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia or relapse from CR.
- 18 year or older and willing and able to comply with the protocol requirements.
- Patient has signed informed consent.
- Unless a female patient is post-menopausal or surgically sterilized, must be willing to use an acceptable method of birth control (hormonal contraceptive, intrauterine device, diaphragm, with spermicide, condom with spermicide, or abstinence) for the duration of the study.
Key exclusion criteria (13 listed)
- Pregnant or breast-feeding
- History of allergic reaction to compounds containing boron or mannitol.
- Active uncontrolled viral (including HIV), bacterial, or fungal infection.
- Grade III or IV toxicity due to previous anti-neoplastic therapy (except alopecia).
- Grade > or equal to 2 motor or sensory neuropathy as defined by the NCI Common Toxicity Criteria (NCI CTC):
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 |
|---|---|---|
| Liposomal Doxorubicin/Melphalan/BortezomibAlso: Liposomal Doxorubicin=Doxil, Melphalan=Alkeran, Bortezomib=VelcadeDay 1 Bortezomib 0.7 mg/m(2)IV + Doxil 10-20 mg/m(2)IV+Melphalan 5-10mg/m(2)IV Day 4 Bortezomib 0.7 mg/m(2)IV Day 8 Bortezomib 0.7 mg/m(2)IV Day 11 Bortezomib 0.7 mg/m(2)IV The treatment cycles will be repeated every 28 days. Dose Level 1: Doxil 10mg/m(2), Melphalan 5 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 2: Doxil 10mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 3: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 4: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 1.0mg/m(2) | Drug | – |
Primary outcome
--To evaluate the safety and tolerability of four dose levels of liposomal doxorubicin, melphalan, and bortezomib in patients with relapsed/refractory MM and to identify a maximum tolerated dose of this combination.
Time frame: 6 years
1 secondary outcome
--To determine the efficacy of DMV therapy --Tabulate all the toxicities of DMV at the MTD by NCI criteria
Time frame: 6 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- UCSF Cancer Center Home PageLink provided by the sponsor.
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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.
Thomas G. Martin, M.D. principal investigator
University of California, San Francisco
1 site 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 Liposomal Doxorubicin/Melphalan/Bortezomib in people with Multiple Myeloma, run by University of California, San Francisco 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 20 inclusion and 13 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: withdrawn, as of the sponsor's last update on 4 Mar 2015. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
--To evaluate the safety and tolerability of four dose levels of liposomal doxorubicin, melphalan, and bortezomib in patients with relapsed/refractory MM and to identify a maximum tolerated dose of this combination. (time frame: 6 years). 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 4 Mar 2015; AzTrials last refreshed its copy on 7 Nov 2026.