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Trial record 65 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade

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ClinicalTrials.gov Identifier: NCT01215344
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : June 28, 2017
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: VELCADE Drug: Lenalidomide Drug: Dexamethasone Drug: DVT prophylaxis Drug: Bisphosphonates Drug: Liposomal doxorubicin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade Based Therapy
Study Start Date : November 2010
Actual Primary Completion Date : November 2015
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: VRD
VELCADE, Lenalidomide, Dexamethasone
Drug: VELCADE
1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle

Drug: Lenalidomide
25 mg by mouth on days 1-4 of each cycle

Drug: Dexamethasone
20 mg the day before and the day after receiving VELCADE

Drug: DVT prophylaxis
At least one asprin 81 mg per day. Other option per physician's choice

Drug: Bisphosphonates
Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.

Experimental: VDD
VELCADE, liposomal doxorubicin, dexamethasone
Drug: VELCADE
1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle

Drug: DVT prophylaxis
At least one asprin 81 mg per day. Other option per physician's choice

Drug: Liposomal doxorubicin
30 mg/m2 on day 4 of each cycle

Drug: Dexamethasone
40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Progression Free Survival by MRD Status at Day 100. [ Time Frame: up to 7 years ]
    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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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215344


Locations
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United States, Tennessee
University of Tennessee Cancer Institute, Boston Baskin Cancer Group
Memphis, Tennessee, United States, 38104
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
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Principal Investigator: Madan Jagasia, MD Vanderbilt-Ingram Cancer Center

Additional Information:
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Responsible Party: Madan Jagasia, MD, Associate Professor of Medicine; Director, Outpatient Transplant Program; Section Chief, Hematology and Stem Cell Transplant; Hematologist/Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01215344     History of Changes
Other Study ID Numbers: VICC BMT 1020
First Posted: October 6, 2010    Key Record Dates
Results First Posted: June 28, 2017
Last Update Posted: May 15, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Hemostatic Disorders
Doxorubicin
Liposomal doxorubicin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Dexamethasone
Dexamethasone acetate
Lenalidomide
Bortezomib
BB 1101
Diphosphonates
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs