MULTIPLE MYELOMA and other monoclonal gammopathies

Imagen Dr. Jesús San Miguel

Monoclonal gammopathies and multiple myeloma are a group of diseases where tumor plasma cells grow abnormally in the bone marrow and a monoclonal protein increases in the blood and/or urine.

Multiple myeloma is the second most frequent blood tumor after lymphomas. Treatment for this disease has changed dramatically in the recent years thanks to the development of new therapies, such as the approval of 5 new drugs that have doubled the survival rate of patients with myeloma.

We are a reference center of the Spanish Myeloma Group; we receive and diagnose 3 to 4 cases a day.

Also, we are a reference center for pre-clinical research for new treatments, collaborating with different pharmaceutical companies and offering a training facility for over 100 foreign physicians that come to train in our hospital every year.

At the Clinica Universidad de Navarra we offer personalized treatment and follow-up for our patients. The drugs we administer and their intensity are individualized according to the particular characteristics of each patient. 

There are three types:

1. Monoclonal gammopathy of undetermined significance (MGUS): the most frequent type. It is a “benign” condition, with presence of a monoclonal protein in the blood or urine due to a slight increase of plasma cells, with no other alterations. Eleven percent of these cases evolve into multiple myeloma.

2. Asymptomatic / smoldering myeloma: in this case there is a larger amount of tumor cells in the bone marrow and a larger amount of monoclonal protein in the blood and/or urine, but no symptoms are present. The evolution is uncertain; some cases behave like a “benign” monoclonal gammopathy and others evolve into an active myeloma, becoming high-risk patients.

3. Multiple myeloma: this type shows symptoms such as anemia, bone damage, kidney failure of increase of calcium in the blood, and other analytic or radiological alterations that require immediate treatment.

Imagen del equipo de médicos asistenciales e investigadores del mieloma múltiple. Clínica Universidad de Navarra

Multiple myeloma and monoclonal gammopathy medical care and research team of the Clinica Universidad de Navarra and CIMA (Center for Applied Medical Research)

Our goal is to provide a precise diagnosis and early treatment to cure myeloma".



Dr. Jesus San Miguel is a world reference regarding this disease. Dr. San Miguel is currently the Chair of the International Myeloma Society.


We have led the changes in the diagnosis and response criteria for this disease. Our team has over 20 professionals researching on myeloma.


Currently, we have over 30 open clinical trials to offer new opportunities to our patients.

  • Dr. Jesus San Miguel is a world reference on this disease and Chair of the International Myeloma Society.
  • Our professional team has led the changes in the diagnosis and response criteria for myeloma in the International Myeloma Working Group
  • Reference center of the Spanish Myeloma Group for diagnosis: each day we receive 3-4 cases for evaluation.
  • Reference center for pre-clinical research in collaboration with different pharmaceutical companies to speed-up the step between the laboratory and the patient.
  • Over 20 professionals researching on myeloma
  • Over 30 open clinical trials in our center
  • Over 25 scientific publications in first level international journals
  • Training center for foreign physicians. Over 100 foreign hematologists come every year to train in our service.

Our professional team has contributed to:

  • The approval of at least, 5 drugs: Bortezomib (New England Journal of Medicine 2008, Lancet Oncology 2010), Lenalidomide (New England Journal of Medicine 2003), Pomalidomide (Lacet Oncology 2013), Panobinostat (Lancet Oncology 2014) y Daratumumab (New England Journal of Medicine 2015, New England Journal of Medicine 2017).
  • The construction of the current prognosis classification of myeloma in stages (ISS) (Journal of Clinical Oncology 2005).
  • The improvement of diagnosis criteria (Lancet Oncology 2014) and the assessment of the response to treatment (Lancet Oncology 2016), as part of the International Myeloma Working Group.
  • Predicting the risks of transformation of the pre-malignant forms to malignant (New England Journal of Medicine 2013, Lancet Oncology 2016).

We are conducting over 30 open clinical trials in all stages of the disease and all drugs under evaluation for myeloma, and also all types of autologous and allogeneic transplants

CAR cells anti BCMA

Monoclonal antibodies:

  • Daratumumab
  • Isatuximab
  • Bispecific antibodies targeting BCMA

New generation proteasome inhibitors:

  • Oprozomib
  • Carfilzomib

New immunomodulators

  • Pomalidomide
  • CELMODs, 3rd generation immunomodulator drugs

New alkylators

  • Melflufen

Checkpoint inhibitors

Other drugs (selective inhibitors)

  • Venetoclax
  • Selinexor
  • Panobinostat


We offer personalized medicine with a comprehensive genetic and phenotype diagnoses to provide each patient with the best possible treatment.

Flow cytometry is a key instrument for diagnosis and prognosis valuations of monoclonal gammopathies. It allows precise characterizing of markers in plasma cells of a myeloma to guide diagnosis and prognosis.

We have led the most sensitive methods to detect the minimal residual disease in order to obtain higher precision when monitoring the efficiency of treatments.

Imagen del Dr. Bruno Paiva. Hematólogo y Codirector de CIMA LAB Diagnostics

Flow cytometry has been key when modifying the latest response classification of myeloma and establishing the negative prognosis of the persistence of the negative minimal residual disease".


Deputy Scientific Director of CIMA LAB Diagnostics

The genetic classification of myeloma is fundamental to establish an adequate prognosis.

Studies on mutations and sequencing have allowed finding unfavorable mutations among patients where others tests result normal. These studies guide the use of certain treatments.

  • Karyotype
  • FISH in selected plasma cells
  • Mutation panel
  • Massive sequencing studies
Imagen de la Dra. Mª José Calasanz. Codirectora de CIMA LAB Diagnostics

We count on all the genetic and genomic techniques to diagnose hereditary diseases (monogenic pathology, syndromes and hereditary cancer), as well as diagnostic, predictive and prognostic markers in solid tumors and hematologic neoplasias".


Deputy Scientific Director of CIMA LAB Diagnostics

Positron Emission Tomography (PET): with glucose and methionine. The latter radiopharmaceutical has a wider diagnostic sensitivity for myeloma.

Full-body CAT with low doses of radiation: allows obtaining high-quality images with higher sensitivity than conventional X-rays.

3-Tesla MRI: the most potent resonance that obtains higher precision diagnoses of images.

We are one of the three groups in the world working on the evaluation of methionine to diagnose myeloma. This radiopharmaceutical provides higher sensitivity and diagnostic specificity that glucose".


The symptoms of the disease are derived from the uncontrolled proliferation of plasma cells in the bone marrow. These cells displace normal cells, resulting in a picture of anemia with its associated symptoms: fatigue, pallor, tachycardia, hot flushes, etc.

There is also bone destruction that can cause more or less intense bone pain and even spontaneous fractures or fractures to minimal trauma.

In addition, atypical cells produce and secrete an abnormal immunoglobulin to the blood (component or monoclonal band) that when filtered by the kidney can cause renal failure.

In the recent years, new progress has been made regarding this disease, increasing significantly these patients’ survival rate.

In patients under 70 that fulfill the criteria, the ideal treatment is the bone marrow self-transplant.

4-5 induction treatment cycles with new drugs (bortezomib, thalidomide, lenalidomide, etc.) and then self-transplant. After, new drugs can be administered to consolidate and maintain the response to the disease.

If the patient is not a candidate for bone marrow self-transplant, the indicated treatment is to administer alkylation agents: melphalan, prednisone, etc, previously the classic treatment, but adding these new drugs:

  • Monoclonal antibodies such as daratumumab, isatuximab, bispecific antibodies anti BCMA.
  • New immunomodulators: Pomalidomide, lenalidomide, etc.
  • New generation proteosome inhibitors: oprozomib, carfilzomib, etc.
  • Other selective inhibitor drugs: venetoclax, selinexor, panobinostat, etc.

The Clinica Universidad de Navarra currently has 45 open clinical trials about multiple myeloma that provide a therapeutic opportunity for our patients as they can have access to these new drugs.

Thanks to these clinical trials we have contributed to the approval of at least 5 new drugs to fight against this disease: Bortezomib (New England Journal of Medicine 2008, Lancet Oncology 2010), Lenalidomide (New England Journal of Medicine 2003), Pomalidomide (Lacet Oncology 2013), Panobinostat (Lancet Oncology 2014) y Daratumumab (New England Journal of Medicine 2015, New England Journal of Medicine 2017).

Imagen del equipo de investigación del ensayo clínico de Celgene sobre el mieloma múltiple.
This is Sven’s story, a patient treated in the Clinic for a multiple myeloma

We have the most sophisticated developments, such as molecular biology studies, to assess the multiple prognostic factors that are essential for selecting the most appropriate treatment for each patient.”

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Clinical professionals perform a continuing research and training, always to the benefit of the patient.

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Researched to offer new possibilities and the latest therapeutic advances
for our patients.

Imagen de un investigador del Área de Terapia Celular de la Clínica Universidad de Navarra