- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01215344
First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade
April 15, 2018 updated by: Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Memphis, Tennessee, United States, 38104
- University of Tennessee Cancer Institute, Boston Baskin Cancer Group
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Nashville, Tennessee, United States, 37232
- Vanderbilt-Ingram Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: VRD
VELCADE, Lenalidomide, Dexamethasone
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1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
25 mg by mouth on days 1-4 of each cycle
20 mg the day before and the day after receiving VELCADE
At least one asprin 81 mg per day.
Other option per physician's choice
Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
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Experimental: VDD
VELCADE, liposomal doxorubicin, dexamethasone
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1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
20 mg the day before and the day after receiving VELCADE
At least one asprin 81 mg per day.
Other option per physician's choice
40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
30 mg/m2 on day 4 of each cycle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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6-months post ASCT
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival by MRD Status at Day 100.
Time Frame: up to 7 years
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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
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up to 7 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
October 4, 2010
First Submitted That Met QC Criteria
October 5, 2010
First Posted (Estimate)
October 6, 2010
Study Record Updates
Last Update Posted (Actual)
May 15, 2018
Last Update Submitted That Met QC Criteria
April 15, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplastic Processes
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Neoplasm, Residual
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Antibiotics, Antineoplastic
- Bone Density Conservation Agents
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Lenalidomide
- Bortezomib
- Doxorubicin
- Liposomal doxorubicin
- Diphosphonates
Other Study ID Numbers
- VICC BMT 1020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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