Comprehensive
Cancer Center

¿Qué es el Mieloma Múltiple?
Mieloma es el cáncer de las células plasmáticas en la médula ósea. La sangre contiene tanto glóbulos rojos como glóbulos blancos. Los glóbulos blancos generan los anticuerpos que combaten las infecciones. Existe un tipo de glóbulos blancos (células plasmáticas) que están localizados en las áreas blandas de los huesos humanos. En el mieloma, una de las células plasmáticas se convierte cancerosa y se multiplica. A causa de esta multiplicación, ciertos anticuerpos son creados en una cantidad demasiada grande.

Los pacientes se vuelven anémicos porque el crecimiento de las células plasmáticas interfiere con la producción de las plaquetas y de las células sanguíneas rojas y blancas. Ellas también pueden sufrir infecciones y pueden tener tendencia a descompensarse. Los anticuerpos anormales son peligrosos porque si ellos se acumulan en los riñones, una falla renal puede ocurrir. Tumores de células plasmáticas también pueden formarse, apareciendo en los huesos de la cadera, columna vertebral, costillas y cráneo.

¿Cuáles son los Síntomas Comunes?
Por cuanto el mieloma destruye el hueso, se causa dolor o los huesos pueden colapsar. Los Síntomas pueden incluir::

¿Cuáles son los Factores de Riesgo?
Investigaciones están siendo realizadas por cuanto la causa del mieloma no es aún conocida. Los hombres tienen tendencia a ser afectados ligeramente más que las mujeres, y gente de 40 años o más tienen un riesgo mayor.

Diagnóstico y tratamiento
Un diagnostico puede estar basado en los Síntomas y los resultados de las siguientes pruebas::

Por cuanto el mieloma múltiple empeora con el tiempo, administrar la condición puede extender la calidad de vida. Las opciones de tratamiento incluyen:

Un especialista de la columna vertebral puede ayudar a tratar el dolor causado por esta enfermedad.

If you are diagnosed with Multiple Myeloma, who are the people who will care for you?

Oncologists

Infusion Area Nurses

Radiation Area Nurses

Exam Area Nurses

Pharmacists

Research Coordinators

Nursing Assistants

Social Workers

Nutritionist

Schedulers

Financial Counselors

Treatment Goals
Individualized therapeutic goals are the basis of treatment regimens. These goals may include:

The eradication of all evidence of disease, which may necessitate the patient's accepting greater levels of toxicity

Controlling activity of the disease so that damage to other organs of the body may be prevented by using a toxicity level acceptable to the patient

Preserving the patient's quality of life for as long as possible with minimal intervention

Offering intervention for the management of pain and other disease symptoms

Managing myeloma over the long-term for those patients in remission

Management Options for Myeloma
Myeloma therapy is customized for each patient. There is no standard therapy for active Myeloma. There are, however, therapies that have been traditionally used for the treatment of Myeloma and these have a track record that has been documented in scientific journals.

Many factors must be taken into account in the treatment of Myeloma, such as the patient's general state of health, other medical diseases or issues, how effectively the disease is being controlled, as well as the patient's response to therapy in the past. Many variables must be considered in the diagnosis of Myeloma and in determining its prognosis. There is no single test for Myeloma.

It is recommended that eligible patients participate in clinical trials so that therapies for Multiple Myeloma may be further advanced. Clinical trials are designed to be at least as effective as traditional therapies, especially Phase II and Phase III trials.

The patient's disease classification and disease status determine the scope of management options.

Disease Classification
There are two disease classifications for patients with Multiple Myeloma: inactive disease or active disease.

Asymptomatic in nature, inactive disease does not require immediate treatment. Inactive disease patients do not present with any myeloma-related organ or tissue impairment. Inactive disease includes the following classification subtypes:

Monoclonal gammopathy of undetermined significance (MGUS)

Smoldering myeloma (SMM)

Indolent myeloma (IMM)

Stage I disease

Symptomatic or active disease requires treatment. Patients with Myeloma in Stage II or Stage III disease fall into this category.

Disease Status
Treatment options for those who have already received therapy are different than for those who have not. A patient's disease status is fully taken into account.

Those patients with newly diagnosed disease have myeloma that has not yet been treated.

Patients who have received therapy fall into the following categories:

Responsive disease is the term used to describe myeloma that is responding to therapy. A decrease in M protein of at least 50 percent has been documented. There are Myeloma specialists who consider a decrease in M protein between 25 percent and 50 percent to be minimal response while other medical authorities consider this to fall within the range of stable disease.

Stable disease is the term used to describe Myeloma that has not responded to treatment. While the decrease in M protein has not reached 50 percent, the disease has not gotten worse. There are Myeloma specialists who consider a decrease in M protein between 25 percent and 50 percent to fall within minimal response.

Progressive disease is the term used to describe active Myeloma that is becoming worse. M protein is increasing with accompanying organ or tissue impairment. Relapsed and/or refractory disease can also be considered progressive disease.

Relapsed disease is the term used to describe Myeloma that first responded to therapy but began progressing again at a later time. Patients may be more specifically categorized as having relapsed after initial therapy began or after therapy that followed.

Refractory disease is the term used to describe Myeloma that has not responded to initial therapy. Myeloma that does not respond to subsequent treatment is referred to as relapsed Myeloma. For this type of Myeloma, the condition is also described as relapsed and refractory disease.

There are two types of refractory disease:

Refractory disease that is progressing is referred to as non-responding progressing refractory disease. Because treatment of this type of Myeloma may be difficult, innovative therapy is recommended as an option for treatment.

Refractory disease that is not worsening is referred to as non-responding non-progressing refractory disease. Often patients with this condition do as well as patients who have responsive disease.

Approaches to Treatment
Interventions will vary depending on whether the patient has active or inactive disease.

Active Disease

Initial therapy is administered to patients with newly-diagnosed, active and symptomatic myeloma. These patients also receive bisphosphonates and the supportive care needed to treat bone disease and other complications. After prior treatment and outcomes have been reviewed, subsequent treatment options are decided. Patients have the opportunity to participate in a clinical trial at every step of this intervention.

Inactive Disease

Unless their disease begins to progress, patients with inactive and asymptomatic disease are observed and not treated unless their disease progresses. Where there is evidence of active disease with end organ damage, a clinical trial may be recommended without therapy. For some patients with smoldering or indolent Myeloma or Stage 1 disease, bisphosphonates and other forms of supportive care may be recommended. For patients with inactive disease, Thalidomide and other agents are being tested.

During your treatment for Multiple Myeloma, patient safety is a priority at TCCC

It is the responsibility of all healthcare workers to ensure that all patients are treated in a safe, effective, appropriate, and efficient manner. You caregivers follow a strict set of guidelines to protect your safety, including:

Improving the accuracy of patient identification--using at least two patient identifiers whenever administering medications, taking blood samples and other specimens for clinical testing, or providing any other treatments or procedures.

Improving the effectiveness of communication among caregivers.

Utilizing a list of drugs with look-alike/sound-alike names, abbreviations, acronyms and symbols to prevent errors involving the interchange of these drugs.

Reducing the risk of health care-associated infections.

Reducing the risk of patient harm or injuries resulting from falls.

Obtaining and documenting an accurate and complete list of the patient's current medications and communicating this list to the next provider of service when a patient is referred or transferred to another setting, service, practitioner or level of care within or outside the organization.

You should always should feel that you have the opportunity to ask questions and that you are given ample time by the caregiver to respond to your questions.

If something is bothering you, tell your team. Don't be shy about asking for help with controlling pain, depression, or any other concern. Keep a diary so you can keep a record of issues and concerns and then follow up with a phone call or visit to you doctor.

Trinitas Cancer Center Announces Clinical Trial To Begin For Previously Untreated Patients With Multiple Myeloma
A Phase II Trial with VELCADE® (PS-341), Cytoxan (cyclophosphamide), Dexamethasone and Thalomid® (VEL-CTD)

Aptium Oncology Research Network Protocol #05-MM-01*

Trinitas Comprehensive Cancer Center (Trinitas CCC) announced today its participation in a nationwide, multi-center clinical trial for previously untreated patients with multiple myeloma. As part of the Aptium Oncology Research Network, Trinitas CCC is working in partnership with several U.S. cancer centers and principal investigators. Dr. Gerardo Capo is serving as the principle investigator locally at Trinitas CCC. Participation in the 05-MM-01 study is currently available in NJ through the Trinitas Comprehensive Cancer Center, which is currently one of 10 medical facilities in the United States accepting volunteers for this Phase II study.

Heading the study for the Aptium Oncology Research Network is Dr. Brian Durie from the Cedars Sinai Outpatient Cancer Center in Los Angeles. Dr. Durie is the National Director for Hematology Malignancies for Aptium Oncology and Chairman of the International Myeloma Foundation. Also leading this study and collaborating with Trinitas CCC is Dr. Sundar Jagannath, Chief of the Multiple Myeloma Program and Bone Marrow and Stem Cell Transplantation Program at St. Vincent's Comprehensive Cancer Center in New York City and Editor-in-Chief of Clinical Lymphoma & Myeloma.

Trinitas CCC researchers hope to move rapidly to begin this clinical trial. The Phase II study is open label, single arm and multi-institutional. It will evaluate an investigational* treatment regimen that includes sequential use of multiple myeloma drugs. The drugs in this study consist of VELCADE® (developed and provided by Millennium Pharmaceuticals, Inc.), Cytoxan (commercially available), dexamethasone (commercially available), and Thalomid® [provided by Celgene Corporation through the PTAP (Protocol Treatment Assistance Program)] and will be administered in varying doses and combinations in six treatment cycles.

Over the past three decades, the treatment for multiple myeloma has been mainly palliative with a median life expectancy of 3 years and less than 10% living 10 years or longer. "Nearly all patients experience a relapse after their initial treatment, and unfortunately, there is still no cure,Ã¢â‚¬Â said Gerardo Capo, Medical Oncology and Hematology specialist at the Trinitas Comprehensive Cancer Center. Ã¢â‚¬Å"The best therapies we have still only provide a controlled remission in the most successful instances. There is clearly an urgent need for more therapies. This clinical trial may offer an option for multiple myeloma.Ã¢â‚¬Â

Participants in the 05-MM-01 clinical trial must meet the following eligibility:

• A confirmed diagnosis of multiple myeloma requiring treatment
• No prior chemotherapy, immunotherapy, vaccine, or other agents for the treatment of active multiple myeloma
• Adequate cardiac, liver and kidney function
• Age 18 or older

"We have some of the best minds in Multiple Myeloma research working on this clinical trial," said Gary Horan, President of Trinitas Hospital. "Cancer is a major focus of our clinical research activities at Trinitas and this clinical trial is a prime example of our commitment to discover possible ways to fight cancer."

For additional information on this clinical trial, please visit our web site at www.trinitasccc.org or contact Maria Serrano, Clinical Research Manager at 908-994-8539.

* The treatment regimens in this study are considered investigational due to the fact that there has not been FDA approval of the use of the drugs in these combinations for the treatment of newly diagnosed multiple myeloma. VELCADE® is currently approved by the United States Food and Drug Administration (US FDA) and it is registered in Europe for the treatment of multiple myeloma patients who have received at least one prior therapy.

Find Out more about Clinical Trials

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Anemia, por tener muy poco hierro en la sangre

Fatiga y cansancio

Infecciones recurrentes

Problemas con los riñones

Dolor severo en los huesos, especialmente en la espalda

Fracturas repentinas de los huesos, usualmente en la espalda, costillas, brazos o piernas

Demasiado calcio en la sangre por la degradación de los huesos

Problemas de sangrado

Confusión, dificultades en la visión y dolores de cabeza (causados al no llegar sangre a la piel, dedos de las manos, dedos de los pies y nariz)

Una prueba de sangre

Prueba de orina

Rayos X de los huesos. Los rayos X mostrarán las lesiones o osteoporosis extendida si es que la persona tiene mieloma múltiple

Imágenes por resonancia magnética (MRI) pueden predecir el resultado para pacientes en las fases iniciales de la enfermedad

Muestras de la médula ósea (biopsia) son observadas con un microscopio. Un número grande de células plasmáticas en varias fases de desarrollo son evidentes en la persona con mieloma múltiple

Por cuanto el mieloma múltiple empeora con el tiempo, administrar la condición puede extender la calidad de vida. Las opciones de tratamiento incluyen:

Transplante de la médula ósea

Quimioterapia

Medicamentos, incluyendo antibióticos para controlar las infecciones, prevenir problemas renales o para controlar la anemia

Radioterapia

Transfusiones para prevenir la anemia sistémica

Oncologists

Infusion Area Nurses

Radiation Area Nurses

Exam Area Nurses

Pharmacists

Research Coordinators

Nursing Assistants

Social Workers

Nutritionist

Schedulers

Financial Counselors

The eradication of all evidence of disease, which may necessitate the patient's accepting greater levels of toxicity

Controlling activity of the disease so that damage to other organs of the body may be prevented by using a toxicity level acceptable to the patient

Preserving the patient's quality of life for as long as possible with minimal intervention

Offering intervention for the management of pain and other disease symptoms

Managing myeloma over the long-term for those patients in remission

Monoclonal gammopathy of undetermined significance (MGUS)

Smoldering myeloma (SMM)

Indolent myeloma (IMM)

Stage I disease

Progressive disease is the term used to describe active Myeloma that is becoming worse. M protein is increasing with accompanying organ or tissue impairment. Relapsed and/or refractory disease can also be considered progressive disease.

Relapsed disease is the term used to describe Myeloma that first responded to therapy but began progressing again at a later time. Patients may be more specifically categorized as having relapsed after initial therapy began or after therapy that followed.

Refractory disease is the term used to describe Myeloma that has not responded to initial therapy. Myeloma that does not respond to subsequent treatment is referred to as relapsed Myeloma. For this type of Myeloma, the condition is also described as relapsed and refractory disease.

There are two types of refractory disease:

Refractory disease that is progressing is referred to as non-responding progressing refractory disease. Because treatment of this type of Myeloma may be difficult, innovative therapy is recommended as an option for treatment.

Refractory disease that is not worsening is referred to as non-responding non-progressing refractory disease. Often patients with this condition do as well as patients who have responsive disease.

Improving the accuracy of patient identification--using at least two patient identifiers whenever administering medications, taking blood samples and other specimens for clinical testing, or providing any other treatments or procedures.

Improving the effectiveness of communication among caregivers.

Utilizing a list of drugs with look-alike/sound-alike names, abbreviations, acronyms and symbols to prevent errors involving the interchange of these drugs.

Reducing the risk of health care-associated infections.

Reducing the risk of patient harm or injuries resulting from falls.

Obtaining and documenting an accurate and complete list of the patient's current medications and communicating this list to the next provider of service when a patient is referred or transferred to another setting, service, practitioner or level of care within or outside the organization.

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