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

NCT01215344 | Completed Phase 2 Results DMC

• 1 other identifier: VICC BMT 1020
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (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).

  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.

  6-months post ASCT

Secondary Outcomes (1)

• Progression Free Survival by MRD Status at Day 100.

  up to 7 years

Study Arms (2)

VRD

EXPERIMENTAL

VELCADE, Lenalidomide, Dexamethasone

Drug: VELCADE; Drug: Lenalidomide; Drug: Dexamethasone; Drug: DVT prophylaxis; Drug: Bisphosphonates

VDD

EXPERIMENTAL

VELCADE, liposomal doxorubicin, dexamethasone

Drug: VELCADE; Drug: DVT prophylaxis; Drug: Liposomal doxorubicin; Drug: Dexamethasone

Interventions

VELCADE DRUG

1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle

VDD; VRD

Lenalidomide DRUG

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

VRD

Dexamethasone DRUG

20 mg the day before and the day after receiving VELCADE

VRD

DVT prophylaxis DRUG

At least one asprin 81 mg per day. Other option per physician's choice

VDD; VRD

Bisphosphonates DRUG

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

VRD

Liposomal doxorubicin DRUG

30 mg/m2 on day 4 of each cycle

VDD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

Study Sites (2)

University of Tennessee Cancer Institute, Boston Baskin Cancer Group

Memphis, Tennessee, 38104, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Lenalidomide; Dexamethasone; Diphosphonates; liposomal doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Organophosphonates; Organophosphorus Compounds

Results Point of Contact

• Title: Madan Jagasa, M.D.
• Organization: Vanderbilt-Ingram Cancer Center

madan.jagasia@vanderbilt.edu

(6150 936-8422

Study Officials

• Madan Jagasia, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine; Director, Outpatient Transplant Program; Section Chief, Hematology and Stem Cell Transplant; Hematologist/Oncologist

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 6, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2018
• Last Updated: May 15, 2018
• Results First Posted: June 28, 2017

Record last verified: 2018-04

Locations

US (2)