Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Melphalan

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Standard of care; High dose Melphalan + Autologous Stem Cell Transplantation

Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation

Treatment with BI-505 10 mg/kg bi-weekly infusion, up to 9 doses over 4 months

BI-505

High dose melphalan

Autologous stem cell transplantation (ASCT)

Autologous stem cell transplantation

Alfred Garfall, MD

The purpose of this study is to investigate the safety and efficacy of administering BI-505 in conjunction with high dose melphalan and stem cell transplantation in multiple myeloma patients.

A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma

A Randomized Phase I/II Study of BI-505 in Conjunction With High-dose Melphalan and Autologous Stem Cell Transplantation for Multiple Myeloma

Volume of distribution at steady state (Vss)

BioInvent International AB

Behaviors and Mental Disorders

Quality of Life

Lenograstim

Busulfan

Busulfan test dose (32 mg/m\^2) on day -9 then 130 mg/m\^2 intravenous (IV) Days -7, -6, -5, and -4 + Melphalan 70 mg/m2 IV on Days -2 and -1. Stem Cell Transplant (SCT) Day 0.

High-dose Melphalan 200 mg/m2/day IV over 30 minutes on day -2. SCT Day 0.

Test dose (32 mg/m\^2) on day -9 then 130 mg/m\^2 by vein or adjusted dose on Days -7, -6, -5, and -4.

70 mg/m2 by vein over 30 minutes minutes on Days -2 and -1.

Quality of Life (QOL) questionnaire before starting the study drugs and then once every 4 weeks after the stem cell transplant, taking about 15 minutes to complete.

Questionnaire

Approximately 5 mcg/kg/day subcutaneously beginning on Day +5.

G-CSF

200 mg/m2 by vein over 30 minutes on Day -2.

High Dose Melphalan

Stem cell transplant

Muzaffar H. Qazilbash, MD

The goal of this clinical research study is to compare Busulfex (busulfan) with or without Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in patients who will receive an autologous stem cell transplant. The safety of this combination therapy will also be studied.

Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups.

* Group 1 will receive melphalan and busulfan.
* Group 2 will receive melphalan.

Both groups will have a stem cell transplant.

Study Drug Administration:

If you are in Group 1, you will first receive an additional low-level "test" dose of busulfan given by vein to check how your blood levels change over time. This information will be used to decide the next dose that is needed to reach a target blood level of busulfan. Blood (about 1 teaspoon each time) will be drawn up to 11 times during the next 11 hours after the test dose and the first high-dose busulfan treatment.

A heparin lock line will be placed in a vein to lower the number of needle sticks needed for these draws.

This test dose of busulfan can be given as an outpatient before you are admitted to the hospital, or you will be admitted on Day -10 (10 days before your transplant) and will receive the test dose on Day -9. If it is not possible for these blood level tests to be performed for technical or scheduling reasons, you will receive the standard, fixed (unchanging) dose of busulfan.

Eight (8) or 10 days before the transplant, you will be admitted to the hospital and given hydration fluids by vein.

On Days -7, -6, -5, and -4, you will receive busulfan by vein over 3 hours. You will receive melphalan on Days -2 and -1 by vein over 30 minutes. You will receive the stem cell transplant through the CVC on Day 0.

If you are in Group 2, you may be admitted to the hospital 3 days before the transplant. You will receive hydration fluids by vein. Two (2) days before the transplant, you will receive melphalan by vein over 30 minutes. You will not receive melphalan the day before the transplant.

Stem Cell Transplant:

The day that you receive the stem cell transplant is called Day 0. The stem cells will be given by vein through the CVC. The cells will travel to your bone marrow where they are designed to start making healthy, new blood cells after several weeks. You will sign a separate consent for the collection of your stem cells.

Beginning 5 days after the transplant, you will receive filgrastim (G-CSF) through a needle under your skin 1 time each day until your blood cell levels return to normal. Filgrastim is designed to help with the growth of white blood cells.

You will be in the hospital after the transplant for about 2-4 weeks.

Questionnaire:

You will be asked to complete a quality-of-life questionnaire before starting the study drugs and then once a week during Weeks 1, 2, and 4 after the stem cell transplant. The questionnaire will take about 15 minutes to complete.

Follow-Up Visits:

About 3 months after the transplant, you will have a bone marrow aspiration and biopsy to check the status of the disease. To collect a bone marrow aspiration and biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

Every 3 months during the first year after the transplant, blood (about 1-2 tablespoons) will be drawn to check your immune response and status of the disease.

About 1 year after the transplant, you will have a bone scan if the doctor thinks it is needed.

Length of Study:

One (1) year after the transplant, your participation in this study will be over.

If intolerable side effects from the chemotherapy occur or there is sign of disease after the transplant, you will be taken off study. If you have intolerable side effects after you receive chemotherapy, then you will still have the transplant. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant doctor decides it is needed.

This is an investigational study. Busulfan and melphalan are commercially available and FDA approved for the treatment of myeloma. The use of melphalan alone before an autologous stem cell transplant is considered standard of care. Using busulfan with melphalan is investigational.

Up to 205 patients will take part in this study. All will be enrolled at MD Anderson.

A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma

Participants that are still alive and without Multiple Myeloma 3 years after Stem cell Transplantation.

Complete response (CR), evaluated 90 days from transplant, defined as (i) negative immunofixation of the multiple myeloma (MM) protein in urine and serum, (ii) disappearance of any soft tissue plasmacytomas, and (iii) less than 5% plasma MM cells in the bone marrow. International Myeloma Working Group uniform response criteria.

Otsuka Pharmaceutical Development & Commercialization, Inc.

M.D. Anderson Cancer Center

Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant

Busulfan + Melphalan

High-dose Melphalan 200 mg/m2/day followed by a stem cell transplant

Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant.

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Muzaffar H. Qazilbash / Stem Cell Transplantation and Cellular Therapy

Progression-Free Survival (PFS)

Number of Participants With Complete Response (CR)

Treatment-Related Mortality (TRM) Between 2 Arms.

Grade 3 - Diarrhea

Grade 3 - Elevated ALT

Grade 3 - Elevated Tbili

Grade 3 - Infection

Grade 3 - Mucositis

Grade 3 - Nausea

Grade 3 - Neuropathy

Grade 3 - Neutropenic fever

Grade 3 - Pneumonia

Grade 3 - Tachycardia

Grade 3 - Transient blindness

Grade 3 - Anorexia

Grade 3 - Myocardial ischemia

Grade 3 - Pleural effusion

Grade 3 - Rash

Number of Participants That Had Grade 3-4 Toxicities.

Overall Survival (OS)

Overall Study

Antirheumatic Agents

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Cyclophosphamide

Dexamethasone

Lenalidomide

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Angiogenesis Inhibitors

Growth Inhibitors

Oral therapy with Cyclophosphamide, Lenalidomide and Dexamethasone.

High dose Melphalan therapy (200 mg/m2) followed by stem cell support for 2 cycles every 4 months (for 1 cycle if at least VGPR was achieved after the 1st MEL200)

Cyclophosphamide will be given orally at the dose of 300 mg/m2 on days 1, 8, 15 for 6 cycles every 28 days

Lenalidomide will be given orally at the dose of 25 mg/d for 21 days followed by a 7 days rest period (day 22 to 28)for 6 cycles every 28 days

Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15, 22 for 6 cycles every 28 days

Melphalan will be given iv at the dose of 200 mg/m2 for 1 day followed by stem cell support. The second MEL200 was performed 120 days after the first if ≤ PR was achieved after the 1st MEL200.

Francesca Gay, MD

This is a multicenter, randomized, open label study designed to compare the efficacy and safety of lenalidomide with low-dose alkylating agents versus high-dose melphalan followed by stem cell support in newly diagnosed symptomatic MM patients who are 65 years of age or younger.

Cyclophosphamide, Lenalidomide and Dexamethasone (CRD) Versus Melphalan (200 mg/m2) Followed By Autologous Stem Cell Transplant (ASCT) In Newly Diagnosed Multiple Myeloma Subjects

A Phase 3, Multicentre, Randomized, Controlled Study to Determine the Efficacy and Safety of Cyclophosphamide, Lenalidomide and Dexamethasone (CRD) Versus Melphalan (200 mg/m2) Followed By Stem Cell Transplant In Newly Diagnosed Multiple Myeloma Subjects

Fondazione EMN Italy Onlus

Prednisone

Oral therapy with Lenalidomide Melphalan and Prednisone.

High dose Melphalan therapy (200mg/sm)with autologous stem cell support, for 2 cycles every 4 months (only 1 cycle if the patient reached almost a VGPR after the 1st MEL200)

High dose Melphalan 200mg/sm with autologous stem cell support

Six months of oral therapy with Lenalidomide 10mg/day given 21 days in every 28 days cycle with the combination ofMelphalan and steroids (day 22 to 28), for 6 cycles every 28 days.

Given orally at the dose of 2 mg/Kg for 4 days followed by a 24 day rest period (days 5 to 28), for 6 cycles every 28 days

Melphalan will be given orally at the dose of 0.18 mg/Kg for 4 days, followed by a 24 days rest period (day 5 to 28)for 6 cycles every 28 days

To compare the efficacy of the combination of lenalidomide with low-dose melphalan versus high-dose melphalan in newly diagnosed, symptomatic MM patients.

Lenalidomide Melphalan and Prednisone Versus High Dose Melphalan in Newly Diagnosed Multiple Myeloma Patients

A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF LENALIDOMIDE, MELPHALAN AND PREDNISONE (MPR) Versus MELPHALAN (200 mg/m2) FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE MYELOMA SUBJECTS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma	NCT02756728	Multiple Myelom...	BI-505 High dose melph... Autologous stem...	18 Years - 70 Years	BioInvent International AB
A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma	NCT01413178	Myeloma	Busulfan Melphalan Questionnaire G-CSF High Dose Melph... Stem cell trans...	18 Years - 70 Years	M.D. Anderson Cancer Center
Cyclophosphamide, Lenalidomide and Dexamethasone (CRD) Versus Melphalan (200 mg/m2) Followed By Autologous Stem Cell Transplant (ASCT) In Newly Diagnosed Multiple Myeloma Subjects	NCT01091831	Multiple Myelom...	Cyclophosphamid... Lenalidomide Dexamethasone Melphalan	18 Years - 65 Years	Fondazione EMN Italy Onlus
Lenalidomide Melphalan and Prednisone Versus High Dose Melphalan in Newly Diagnosed Multiple Myeloma Patients	NCT00551928	Multiple Myelom... Newly Diagnosed...	Melphalan Lenalidomide Prednisone Melphalan	18 Years - 65 Years	Fondazione EMN Italy Onlus
Lenalidomide Melphalan and Prednisone Versus High Dose Melphalan in Newly Diagnosed Multiple Myeloma Patients	NCT00551928	Multiple Myelom... Newly Diagnosed...	Melphalan Lenalidomide Prednisone Melphalan	18 Years - 65 Years	Fondazione EMN Italy Onlus

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