Multiple MyelomaPhase 2NCT01215344
First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade
A Phase 2 study testing VELCADE, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Vanderbilt-Ingram Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to study the MRD status after VELCADE based induction therapy (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on MRD status post-transplant. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- VELCADE, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Mar 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed Multiple Myeloma as defined below within 120 days of starting cycle 1:
- Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
- Presence of M protein in serum or urine or both. Conventional M spike, serum free light chains, or 24 hour urine study. Non-secretory myeloma is not eligible for this study.
- In addition patient must have one of the following organ dysfunction criteria
- Hypercalcemia
- Renal insufficiency
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- Anemia
- Bone disease manifested by lytic lesion or osteoporosis (if osteoporosis is the only organ dysfunction criteria then BM should have ≥ 30% plasma cells)
- Confirmed Multiple myeloma as defined above within 90 days of starting cycle 1
- The following study assessments must be fulfilled and must be obtained with four weeks of starting cycle 1
- Hemoglobin > 7 g/dL, Platelet count > 75 X 10 to 9th power/L, and Absolute neutrophil count > 1 X 10 to 9th power/L
- Creatinine <2.5 mg/dL or calculated creatinine clearance > 30 ml/min/1.72 m2
- Bilirubin ≤ 1.5 mg/dL X ULN
- SGPT (ALT) and SGOT (AST) ≤ 2.5 times the upper limit of normal
- Ejection fraction ≥ 45% as measured by a MUGA scan or 2 D echocardiogram
- Pulmonary function tests show >60% predicted values for FVC, FEV1, and DLCO FEV1 must be > 1 liter.
- No prior systemic therapy with the exception of bisphosphonates for MM
- Prior glucocorticoid therapy for the treatment of multiple myeloma is not permitted EXCEPT if used in conjunction with palliative radiation to prevent vasogenic edema. In that case steroids should have been used for less than 7 days. Prior steroid use for non-malignant disorders is permitted and should have been restricted to less than the equivalent of prednisone 10 mg per day. Prior or concurrent topical or localized steroid therapy to treat non-malignant disorders is permitted
- Prior palliative and/ or localized radiation therapy is permitted provided at least 4 weeks have passed from date of last radiation therapy to starting cycle 1.
- Patients with prior solitary plasmacytoma treated with radiation therapy with curative intent are eligible if the disease has now progressed to active multiple myeloma and meeting all eligibility criteria for the protocol
- ECOG PS 0, 1 or 2
- For women of childbearing potential a negative serum pregnancy test is required within 4 weeks of starting cycle 1 and then every 4 weeks during the first 4 cycles of induction therapy
- Women of child bearing potential must be willing to refrain from sexual intercourse or willing to employ a dual method of contraception, one of which is highly effective (IUD, birth control pills, tubal ligation or partner's vasectomy) and another additional method (condom, diaphragm, or cervical cap) during the entire course of the study (start of therapy until 30 days after stem cell transplant).
- Sexually active males should be willing to use a condom (even if they have had a prior vasectomy) while having intercourse with any women during the course of the study (start of therapy until 30 days after stem cell transplant).
- 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.
Who cannot join
- Patients with smoldering myeloma or monoclonal gammopathy of unknown significance are not eligible
- Age > 70 years or < 18 years is not eligible
- Patient has > 1.5 × ULN Total Bilirubin
- Grade 2 or higher peripheral neuropathy due to ANY cause
- High index of suspicion of primary amyloid light chain (AL) amyloidosis.
- Patients with uncontrolled inter-current illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance or a prior history of Steven Johnson syndrome
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- Patients must not have a history of current or previous deep vein thrombosis or pulmonary embolism regardless of whether or not the patient is receiving anticoagulation therapy
- Female patients who are breastfeeding or pregnant.
- Patients known to be HIV positive
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 31.3), 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 has to be documented by the investigator as not medically relevant.
- Patient has hypersensitivity to VELCADE, boron or mannitol.
- Patient has received other investigational drugs within 14 days before enrollment
- 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
University of Tennessee Cancer Institute, Boston Baskin Cancer Group
Memphis, Tennessee, 38104
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Impact of First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade Based Therapy
The purpose of this study is to study the MRD status after VELCADE based induction therapy (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on MRD status post-transplant. Our hypothesis is that MRD-status will continue to increase significantly at 3 months post-transplant and will validate that HDC and ASCT needs to be performed even when patients have achieved major response after induction therapy with novel agents.
- Conditions
- Multiple Myeloma
- Being tested
- VELCADE, Lenalidomide, Dexamethasone, DVT prophylaxis, Bisphosphonates
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VELCADEDrug
1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
LenalidomideDrug
25 mg by mouth on days 1-4 of each cycle
DexamethasoneDrug
20 mg the day before and the day after receiving VELCADE
DVT prophylaxisDrug
At least one asprin 81 mg per day. Other option per physician's choice
BisphosphonatesDrug
Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
Liposomal doxorubicinDrug
30 mg/m2 on day 4 of each cycle
DexamethasoneDrug
40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
| Study group | Role | What they receive |
|---|---|---|
| VRD | Experimental | VELCADE, Lenalidomide, Dexamethasone Receives: Drug: VELCADE; Drug: Lenalidomide; Drug: Dexamethasone; Drug: DVT prophylaxis; Drug: Bisphosphonates |
| VDD | Experimental | VELCADE, liposomal doxorubicin, dexamethasone Receives: Drug: VELCADE; Drug: DVT prophylaxis; Drug: Liposomal doxorubicin; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percent of Patients With Minimal Residual Disease (MRD) Status Changing to Negative at Day 100 (Post-AHCT), Among Patients With MRD Positive at the End of Induction (EOI).
Patients were treated with induction therapy (VRD) followed by autologous hematopoietic cell transplant (AHCT). MRD status of a patient with at least partial response was evaluated at the end of induction (EOI) and day 100 (post-AHCT). MRD of a patient is measured by seven-color flow cytometry.
Measured: 6-months post ASCT
Secondary outcomes (1)
Progression Free Survival by MRD Status at Day 100.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2015
- Study completionMar 2018
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Madan Jagasia, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215344
- Sponsor's protocol ID
- VICC BMT 1020
- Status last verified
- Apr 2018
- First submitted
- 4 Oct 2010
- Last updated
- 15 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade Based Therapy
- ClinicalTrials.gov ID
- NCT01215344
- Acronym / sponsor ID
- VICC BMT 1020
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Posted 28 Jun 2017
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 study the MRD status after VELCADE based induction therapy (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on MRD status post-transplant. Our hypothesis is that MRD-status will continue to increase significantly at 3 months post-transplant and will validate that HDC and ASCT needs to be performed even when patients have achieved major response after induction therapy with novel agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRD | Experimental | Drug: VELCADE, Drug: Lenalidomide, Drug: Dexamethasone, Drug: DVT prophylaxis, Drug: BisphosphonatesVELCADE, Lenalidomide, Dexamethasone |
| VDD | Experimental | Drug: VELCADE, Drug: DVT prophylaxis, Drug: Liposomal doxorubicin, Drug: DexamethasoneVELCADE, liposomal doxorubicin, dexamethasone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
- Presence of M protein in serum or urine or both. Conventional M spike, serum free light chains, or 24 hour urine study. Non-secretory myeloma is not eligible for this study.
- In addition patient must have one of the following organ dysfunction criteria
- Hypercalcemia
- Renal insufficiency
Key exclusion criteria (13 listed)
- Patients with smoldering myeloma or monoclonal gammopathy of unknown significance are not eligible
- Age > 70 years or < 18 years is not eligible
- Patient has > 1.5 × ULN Total Bilirubin
- Grade 2 or higher peripheral neuropathy due to ANY cause
- High index of suspicion of primary amyloid light chain (AL) amyloidosis.
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 |
|---|---|---|
| VELCADE1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle | Drug | VDD, VRD |
| Lenalidomide25 mg by mouth on days 1-4 of each cycle | Drug | VRD |
| Dexamethasone20 mg the day before and the day after receiving VELCADE | Drug | VRD |
| DVT prophylaxisAt least one asprin 81 mg per day. Other option per physician's choice | Drug | VDD, VRD |
| BisphosphonatesZoledronic acid by IB or pamidronate by IV can be used as per standard of care. | Drug | VRD |
| Liposomal doxorubicin30 mg/m2 on day 4 of each cycle | Drug | VDD |
| Dexamethasone40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4 | Drug | VDD |
Primary outcome
The Percent of Patients With Minimal Residual Disease (MRD) Status Changing to Negative at Day 100 (Post-AHCT), Among Patients With MRD Positive at the End of Induction (EOI).
Time frame: 6-months post ASCT
Patients were treated with induction therapy (VRD) followed by autologous hematopoietic cell transplant (AHCT). MRD status of a patient with at least partial response was evaluated at the end of induction (EOI) and day 100 (post-AHCT). MRD of a patient is measured by seven-color flow cytometry.
1 secondary outcome
Progression Free Survival by MRD Status at Day 100.
Time frame: up to 7 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink 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.
Madan Jagasia, MD principal investigator
Vanderbilt-Ingram Cancer Center
2 sites 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, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Vanderbilt-Ingram Cancer 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 25 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: finished, as of the sponsor's last update on 15 May 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.
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 28 Jun 2017). 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 Percent of Patients With Minimal Residual Disease (MRD) Status Changing to Negative at Day 100 (Post-AHCT), Among Patients With MRD Positive at the End of Induction (EOI). (time frame: 6-months post 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 15 May 2018.