Neoplasms

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Multiple Myeloma

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Doxorubicin

Liposomal doxorubicin

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VELCADE, liposomal doxorubicin, dexamethasone

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

VELCADE

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

DVT prophylaxis

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

Bisphosphonates

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

Madan Jagasia, MD

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.

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

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

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.

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

Vanderbilt-Ingram Cancer Center

Associate Professor of Medicine; Director, Outpatient Transplant Program; Section Chief, Hematology and Stem Cell Transplant; Hematologist/Oncologist

VELCADE, Lenalidomide, Dexamethasone

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

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

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

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

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

VRD (VELCADE, Lenalidomide, Dexamethasone)

VELCADE, liposomal doxorubicin, dexamethasone

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

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

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

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

VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Madan Jagasa, M.D.

VELCADE, Lenalidomide, Dexamethasone (VRD)

VELCADE, Liposomal Doxorubicin, Dexamethasone (VDD)

Newly diagnosed, symptomatic multiple myeloma (MM) patients. Patients were treated with induction therapy VRD followed by AHCT. MRD staus was evaluated for patients with at least partial response at the end of induction (EOI) therapy. Ten of these patients had MRD negative at EOI.

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 with MRD status negative at day 100 (post-AHCT). They have MRD negative or positve at EOI.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade	NCT01215344	Multiple Myelom...	VELCADE Lenalidomide Dexamethasone DVT prophylaxis Bisphosphonates Liposomal doxor... Dexamethasone	18 Years - 70 Years	Vanderbilt-Ingram Cancer Center
First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade	NCT01215344	Multiple Myelom...	VELCADE Lenalidomide Dexamethasone DVT prophylaxis Bisphosphonates Liposomal doxor... Dexamethasone	18 Years - 70 Years	Vanderbilt-Ingram Cancer Center

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