Multiple MyelomaPhase 1/2Mel-VelNCT00784823
Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma
A Phase 1/2 study testing Bortezomib 1 mg/m2, Bortezomib 1.3 mg/m2 and Bortezomib 1.6 mg/m2 in people with Multiple Myeloma, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
The purpose of this study is to determine the tolerance and potential efficacy of combining dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma undergoing autologous stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib 1 mg/m2, Bortezomib 1.3 mg/m2 and Bortezomib 1.6 mg/m2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2013
- 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 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed diagnosis of multiple myeloma
- Show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan
- May have received intervening therapies for disease progression after dose-intense melphalan and enrollment in this protocol
- Age:18yrs-76yrs at time of melphalan administration
- Gender: There is no gender restriction
- Availability of >2x10^6 autologous peripheral blood CD34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation
Show all 9Show fewer
- Syngeneic transplantation is preferred
- For patients enrolled in the phase I part of this study, >1x10^6 autologous or syngeneic peripheral blood CD34+ cells/kg remaining in storage as "backup" in case of engraftment failure
- Recovery from complications of salvage therapy, if administered -
Who cannot join
- Diagnosis other than multiple myeloma
- Chemotherapy or radiotherapy within 28 days of initiating treatment in this study
- Prior dose-intense therapy within 56 days of initiating treatment in this study
- Uncontrolled bacterial,viral,fungal or parasitic infections
- Uncontrolled CNS metastases
- Known amyloid deposition in heart
Show all 18Show fewer
- Organ dysfunction
- LVEF<40% or cardiac failure not responsive to therapy
- FVC,FEV1,or DLCO<50% of predicted and/or receiving supplementary continuous oxygen
- Evidence of hepatic synthetic dysfunction, or total bilirubin>2x or AST>3x ULN
- Measured creatinine clearance <20ml/min
- Sensory peripheral neuropathy grade 4
- Karnofsky score<70% unless a result of bone disease directly caused by myeloma
- Life expectancy limited by another co-morbid illness
- History of another malignancy in remission <2yrs (other than basal cell carcinoma)
- Pregnant (women)or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment
- Documented hypersensitivity to melphalan or bortezomib or any components of the formulation
- Patients unable or unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: A Phase I/II Study of Escalating Doses of Bortezomib in Conjunction With High Dose Melphalan as a Conditioning Regimen for Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
The purpose of this study is to determine the tolerance and potential efficacy of combining dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma undergoing autologous stem cell transplantation.
Read the detailed description
Multiple myeloma is the second most common hematological malignancy that has affected approximately 40,000 Americans.Conventional chemotherapy has achieved limited control of this disease but studies have reported improved response rates for patients who are treated with dose-intense therapy and autologous hematopoietic stem cell transplantation. This Phase I/II study will investigate the potential of combination therapy of dose-intense melphalan with escalating doses of bortezomib.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib 1 mg/m2, Bortezomib 1.3 mg/m2, Bortezomib 1.6 mg/m2, 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.
Bortezomib 1 mg/m2Drug
Also called Velcade
- Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line
- Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1
- Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen
Bortezomib 1.3 mg/m2Drug
Also called Velcade
- Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line
- Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1
- Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen
Bortezomib 1.6 mg/m2Drug
Also called Velcade
- Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line
- Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1
- Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen
MelphalanDrug
Also called Alkeran
- Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour
- Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration
- The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period
- Melphalan will be given as a single dose (not split over 2 or more days)
- Dosing will be based body surface area calculated using actual body weight
| Study group | Role | What they receive |
|---|---|---|
| Phase I Cohort - Bortezomib 1 mg/m2 | Experimental | Bortezomib at 1 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2. Receives: Drug: Bortezomib 1 mg/m2; Drug: Melphalan |
| Phase I Cohort - Bortezomib 1.3 mg/m2 | Experimental | Bortezomib at 1.3 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2. Receives: Drug: Bortezomib 1.3 mg/m2; Drug: Melphalan |
| Phase I Cohort - Bortezomib 1.6 mg/m2 | Experimental | Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2. Receives: Drug: Bortezomib 1.6 mg/m2; Drug: Melphalan |
| Phase II Cohort | Experimental | Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2. Receives: Drug: Bortezomib 1.6 mg/m2; Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maximum Tolerated Dose of Bortezomib (MTD)
The Maximum Tolerated Dose of Bortezomib (MTD) Will be Defined as the Dose Level Prior to That Resulting in Two Out of Six Patients Experiencing a DLT
Measured: During dosing of Bortezomib on Day -4 to Day -1 of ASCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2013
- Study completionDec 2013
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.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3 + 3 Dose Escalation
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott D Rowley, MD, Principal investigator, Director-Blood and Marrow Transplantation Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784823
- Sponsor's protocol ID
- 06.05.109B
- Acronym
- Mel-Vel
- Status last verified
- Jul 2022
- First submitted
- 31 Oct 2008
- Last updated
- 11 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Escalating Doses of Bortezomib in Conjunction With High Dose Melphalan as a Conditioning Regimen for Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00784823
- Acronym / sponsor ID
- Mel-Vel / 06.05.109B
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Nov 2008 (estimated)
- Results
- Posted 11 Aug 2022
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 tolerance and potential efficacy of combining dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma undergoing autologous stem cell transplantation.
Detailed description
Multiple myeloma is the second most common hematological malignancy that has affected approximately 40,000 Americans.Conventional chemotherapy has achieved limited control of this disease but studies have reported improved response rates for patients who are treated with dose-intense therapy and autologous hematopoietic stem cell transplantation. This Phase I/II study will investigate the potential of combination therapy of dose-intense melphalan with escalating doses of bortezomib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 3 + 3 Dose Escalation
| Arm | Type | Receives |
|---|---|---|
| Phase I Cohort - Bortezomib 1 mg/m2 | Experimental | Drug: Bortezomib 1 mg/m2, Drug: MelphalanBortezomib at 1 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2. |
| Phase I Cohort - Bortezomib 1.3 mg/m2 | Experimental | Drug: Bortezomib 1.3 mg/m2, Drug: MelphalanBortezomib at 1.3 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2. |
| Phase I Cohort - Bortezomib 1.6 mg/m2 | Experimental | Drug: Bortezomib 1.6 mg/m2, Drug: MelphalanBortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2. |
| Phase II Cohort | Experimental | Drug: Bortezomib 1.6 mg/m2, Drug: MelphalanBortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A confirmed diagnosis of multiple myeloma
- Show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan
- Age:18yrs-76yrs at time of melphalan administration
- Gender: There is no gender restriction
- Availability of >2x10^6 autologous peripheral blood CD34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation
Key exclusion criteria (18 listed)
- Diagnosis other than multiple myeloma
- Chemotherapy or radiotherapy within 28 days of initiating treatment in this study
- Prior dose-intense therapy within 56 days of initiating treatment in this study
- Uncontrolled bacterial,viral,fungal or parasitic infections
- Uncontrolled CNS metastases
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 |
|---|---|---|
| Bortezomib 1 mg/m2Also: Velcade* Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line * Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1 * Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen | Drug | Phase I Cohort - Bortezomib 1 mg/m2 |
| Bortezomib 1.3 mg/m2Also: Velcade* Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line * Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1 * Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen | Drug | Phase I Cohort - Bortezomib 1.3 mg/m2 |
| Bortezomib 1.6 mg/m2Also: Velcade* Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line * Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1 * Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen | Drug | Phase I Cohort - Bortezomib 1.6 mg/m2, Phase II Cohort |
| MelphalanAlso: Alkeran* Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour * Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration * The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period * Melphalan will be given as a single dose (not split over 2 or more days) * Dosing will be based body surface area calculated using actual body weight | Drug | Phase I Cohort - Bortezomib 1 mg/m2, Phase I Cohort - Bortezomib 1.3 mg/m2, Phase I Cohort - Bortezomib 1.6 mg/m2, Phase II Cohort |
Primary outcome
The Maximum Tolerated Dose of Bortezomib (MTD)
Time frame: During dosing of Bortezomib on Day -4 to Day -1 of ASCT
The Maximum Tolerated Dose of Bortezomib (MTD) Will be Defined as the Dose Level Prior to That Resulting in Two Out of Six Patients Experiencing a DLT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Multiple Myeloma
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1/2
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
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.
Scott D Rowley, MD principal investigator
Director-Blood and Marrow Transplantation Program
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 Bortezomib 1 mg/m2, Bortezomib 1.3 mg/m2 and Bortezomib 1.6 mg/m2 in people with Multiple Myeloma, run by Hackensack Meridian 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 9 inclusion and 18 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 11 Aug 2022. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2022). 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?
The Maximum Tolerated Dose of Bortezomib (MTD) (time frame: During dosing of Bortezomib on Day -4 to Day -1 of ASCT). 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 11 Aug 2022.