Symptoms and General Pathology

All Conditions

Syndrome

All Drugs and Chemicals

Antibodies

Immunomodulating Agents

Immunoglobulins

Immunoglobulins, Intravenous

gamma-Globulins

Rho(D) Immune Globulin

Immunologic Factors

Immunoglobulin

Dimitri Psimaras, MD

Paraneoplastic Neurological Syndromes (PNS) are rare remote effects of cancer, not directly attributed to mass lesions, metastases, infections, ischemia, coagulopathy, metabolic disruptions or tumour treatment. Currently, PNS treatment is mostly limited to tumour treatment. Because of an initial inflammatory stage early in the evolution of the PNS several immunotherapy modalities have been tried. Intravenous human immunoglobulins could be expected to provide a stabilization or even improvement of PNS, if administered early enough to prevent permanent neuronal damage.

Paraneoplastic neurological syndromes (PNS) are remote effects of malignant neoplasia on neural tissue, not directly caused by mass lesions, metastases, infections, ischemia, coagulopathy, metabolic disruptions or treatment. The symptoms and signs of PNS are diverse, usually acute or subacute. Onconeural antibodies are detected in their serum, and sometimes in their Cerebrospinal Fluid (CSF); onconeural antibodies are highly specific for identifying patients with neurologic symptoms as having a paraneoplastic syndrome. The most frequent ones are anti-Hu, anti-Yo and anti-CV2/CRMP5. Although a known cancer patient may present with a PNS, neurologic symptoms precede other manifestations of a tumor in about 65% of patients.

Currently, autoimmunity is postulated to underlie the pathophysiology of PNS. Tumor cells can sometimes express antigens normally found only in the nervous system, an immunologically privileged site. Onconeural antigens on tumors can be identified as foreign by the immune system and an immune attack can be elicited against them. In the subset of PNS patients, the immune system could also recognize and attack onconeural antigens in normal nervous tissue. This autoimmune hypothesis for the pathogenesis of PNS is supported by a series of arguments: Onconeural antibodies are found in serum and CSF; Cerebrospinal fluid studies show inflammation in 93% of patients; In the acute phase of paraneoplastic cerebellar degeneration hypermetabolism in 18F-Fluoro-2-Desoxy-Glucose Positron Emission Tomography (FDG-PET) scan and increased perfusion on Single Photon Emission Computed Tomography (SPECT) have been described and attributed to inflammatory changes; Pathological examination of the nervous system from patients with anti-Hu associated paraneoplastic encephalomyelitis demonstrates loss of neurons in affected areas with extensive T-cells infiltration and immunohistochemical studies on damaged neural tissue after autopsy reveal inflammatory infiltrations.

Effective treatment of PNS requires an early clinical suspicion followed by rapid diagnosis, through detection of onconeural antibodies, and identification of the underlying tumor. Unfortunately appropriate treatment of the cancer is most often unsuccessful to improve neurological symptoms and these patients are generally left bedridden until death. It's seems important to associate an immune treatment but has never been adequately tested. Experience with immunotherapy modalities, such as corticosteroids, plasma exchange, immunosuppressants or human intravenous immunoglobulin (IVIg), relies on case reports, retrospective studies, and a couple of prospective studies in patients generally treated at a late stage. To date, it has not been possible to set up a prospective therapeutic trial evaluating the role of early immune treatment, administered less than 6 months after the onset of symptoms, in these patients. Considerable evidence for an initial inflammatory stage (early in the evolution of the PNS), and isolated case reports of early immunological intervention suggest that this approach may be valid to treat these disorders. Because IVIg are often use in neuro-immunological disorders (ex. first-line therapy in Guillain-Barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, multifocal motor neuropathy and dermatomyositis) with little and well known side effects and no interaction with cancer treatment we decide to use IVIg for our trial.

The Aim of the study is to improve neurological impairment and function in patients with early diagnosis of various PNS associated with well-characterized onconeural antibodies anti-Hu, anti-Yo, anti-CV2/CRMP5. The primary endpoint of the study is the percentage of patients with neurological improvement after 3 months of immunotherapy with IVIg. "Success" is defined by ≥ 1 point lower score in the modified Rankin Scale (mRS) after treatment compared to baseline. This is a prospective, open-label trial explores the efficacy of drugs approved for treatment of immune-mediated neurological disorders given early in the evolution of PNS associated with well-characterized onconeural antibodies. A total number of 17 patients will be treated. This is a multicenter study carried under the auspices of the French National Reference Center on PNS.

Immunotherapy and Paraneoplastic Neurological Syndromes

Early Onset Immunotherapy by Intravenous Immunoglobulin in Well-characterized Onconeural-antibody-positive Paraneoplastic Neurological Syndromes

"Success" is defined by ≥ 1 point lower score in the modified Rankin Scale (mRS) after treatment compared to baseline. "Failure" is defined by failure to meet the success definition.

Progression-free survival at 6 months defined as the percentage of patients that remain neurologically stable after 6 months of treatment of defined by the mRS and the PNS Neurological Scale.

Assistance Publique - Hôpitaux de Paris

Neoplasms

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Neoplasm Metastasis

Immunologic Deficiency Syndromes

Primary Immunodeficiency Diseases

Neoplastic Processes

Genetic Diseases, Inborn

Adults with primary or secondary immunodeficiency for whom human immunoglobulin-assisted recombinant human hyaluronidase treatment is initiated

Data record and questionnaires passation (SF36)

Data record and questionnaires passation

Amélie SERVETTAZ

Gauthier LEJEUNE

Primary immunodeficiencies (PID) represent more than 150 diseases affecting the immune system. More than 50% of PIDs are due to a lack or an insufficiency in antibody production. Some of these immunodeficiencies as well as some secondary immune deficiency with deficient antibody production (especially in hematology and oncology) are responsible for repeated and/or severe infections, requiring long-term replacement therapy with intravenous polyclonal immunoglobulin. Intravenous replacement therapy is administered every 21 or 28 days in hospital. Subcutaneous administration (weekly or bi-weekly) can be initiated for patients who cannot tolerate intravenous infusions or who have difficult venous access. However, some patients experience a decrease in quality of life with these more frequent administration at home. A new treatment is available in France since 2017, which is a subcutaneous infusion of human immunoglobulin facilitated by recombinant human hyaluronidase (IGHy), administered every 3 to 4 weeks in a single abdominal site, at home. No direct data are available in adults to evaluate tolerance and satisfaction with this treatment, but we know it is a preferred option in children and adolescents.

The objective of the study is to describe the continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) therapy at 6 months from the start of treatment.

The secondary objectives are to evaluate the quality of life of patients treated with human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) therapy.

Tolerance and Patients' Satisfaction With IGHy

Tolerance and Patients' Satisfaction of Subcutaneous Infusion of Human Immunoglobulin Facilitated by Recombinant Human Hyaluronidase for Primary or Secondary Immunodeficiency

Percentage of patients continuing IGHy treatment at 6 months

quality of life assessed by the SF-36. The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively

CHU de Reims

Blood and Lymph Conditions

Hematologic Diseases

Michel Delforge, MD PhD

The purpose of this observational study is to compare the administration of standard of care Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion time and infusion related reactions. Patient satisfaction, number of actions taken by the nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.

Given the growing number of patient contacts at our day-care center, there is a continuous search to further improve the flow and to shorten the time spent per patient at the day-care center, without loss of quality in care.

In order to achieve this goal, this study wants to compare the administration of Multigam IV 5% and Multigam IV 10%. Multigam 5% and Multigam 10% are immunoglobulin solutions that are administered to strengthen the body's natural defense system (immune system). In case of recurrent infections, patients with an immunodeficiency secondary to a hematologic disorder can be treated with immunoglobulin substitution therapy. Patients can receive Multigam IV 5% and Multigam IV 10% in daily clinical practice and will receive both formulations in the same manner and intensity, meaning their use is not limited to this study.

For this observational study, patients with an immunodeficiency secondary to a hematologic disorder will be evaluated for inclusion. Patient characteristics, infusion time, time spent at the day-care center, adverse events and number of actions taken by the nursing staff will be evaluated for Multigam 5% administration. After 3-4 weeks, patients will return for Multigam 10% administration and an identical evaluation will take place along with a questionnaire for the patient and nursing staff to assess their satisfaction. The results will be processed to compare and evaluate the administration of both immunoglobulin solutions.

Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder

Comparison of Multigam IV (5% vs. 10%) as Substitution Therapy in Patients With an Immunodeficiency Secondary to a Hematological Disorder to Evaluate Infusion Time, Tolerance and Satisfaction. A Monocentric Observational Belgian Study

Comparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.

Comparison of hospitalisation time (time spent at day clinic) between Multigam IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.

Evaluation of the occurence of adverse events (AEs) for both administrations via CTCAE v4.03 criteria.

Results are reported as the mean number of IVIg-related AEs per patient. Adverse events were actively monitored during infusion and patients could report adverse events up to 72h after infusion.

Evaluate the number of actions taken by the nursing staff during Multigam administration. Nursing actions were defined as the sum of actions required to increase the infusion rate (if needed) and any other action that had to be taken due to adverse effects during administration (e.g. lowering of infusion rate or supportive medication). Standard procedures like taking parameters were not accounted for this evaluation.

Assess patient satisfaction via questionnaires. Questionnaires were taken at the end of MG 10% infusion and were validated by the principal investigator (PI) and head nurse.

Patients could score following questions from 1 (strongly disagree) to 5 (strongly agree) \[Full scale: 1: strongly disagree; 2:disagree; 3: neutral; 4: agree; 5; strongly agree\]:

Question 1: I experienced less side effects during Multigam 10% infusion. Question 2: I experienced time gain with Multigam 10%. Question 3: I had a more productive day with Multigam 10%. Question 4: I am in favor of of the use of Multigam 10%.

Universitaire Ziekenhuizen KU Leuven

30 participants who received Multigam 5% intravenous immunoglobulin (IVIg).

Multigam 5% Infusion

30 participants who received Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks after their Multigam 5% infusion.

Multigam 10% Infusion

Baseline characteristics of the study population (30 participants).

All Study Participants

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Belgium

Region of Enrollment

Haematological disorder

Time between first IVIg infusion and start of study

First Multigam Dosage

Datamanager

H0: No difference between Multigam 5% and Multigam 10% infusion time Ha: Multigam 10% infusion time is significantly shorter than Multigam 5%

Multigam 5% infusion

Multigam 10% infusion

30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.

Dosing was set at 0.4 g/kg for both infusions.

Infusion Time of Multigam IV 5% and Multigam IV 10%

H0: No difference in hospitalisation time between Multigam 5% and Multigam 10% infusion Ha: Hospitalisation time with Multigam 10% infusion is significantly shorter than with Multigam 5%

30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.

Hospitalisation Time of Multigam IV 5% and Multigam IV 10%

IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration

H0: No difference in number of nursing actions per patient between Multigam 5% and Multigam 10% infusion Ha: Number of nursing actions per patient is smaller with Multigam 10% infusion

Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration

Question 1

Question 2

Question 3

Question 4

Row 3: 1 patient was unable to assess the question

Patient Satisfaction Questionnaire.

Multigam 5% Infusion (Baseline)

Multigam 10% Infusion (3-4 Weeks Later)

Heart and Blood Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Disease Progression

Bone Marrow Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Antirheumatic Agents

Dexamethasone

Cyclophosphamide

Lenalidomide

Bortezomib

Dexamethasone acetate

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Angiogenesis Inhibitors

Growth Inhibitors

Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 8

Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 8 and cyclophosphamide 500 mg, orally daily, days 1, 8 and 15 for cycle 5 to 8

Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 8 and lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8

Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 8

500 mg, p.o daily, days 1, 8 and 15 for cycles 5 to 8 cycles

1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 for cycles 1 to 8

20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycles 1 to 8

10 mg orally daily, days 1-14 for cycles 5 to 8

Janssen-Cilag International NV Clinical Trial

The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that have achieved a stable response after 4 initial cycles of treatment with VD. Multiple myeloma is the second most common cancer of the blood. Bortezomib disrupts the life cycle of the cell, affecting numerous biologic pathways, including those related to growth and survival of cancer cells.

It has been shown that quality of response corresponds with clinical benefit. Stable disease is not regarded as a satisfactory result of therapy for relapsed and refractory multiple myeloma. However, there is no consensus if, when and how treatment should be continued or changed in the case of stable disease.

There are different strategies of achieving an optimal quality of response in relapsed and refractory multiple myeloma. One is to treat for a longer duration with one regimen. The alternative path can be a sequential approach adding another agent to the initial regimen depending on the outcome of therapy after a defined treatment period. These two principles will be evaluated in the present study.

Both Cyclophosphamide and Lenalidomide have proven to be efficacious in multiple myeloma and combinations of both agents with bortezomib and Dexamethasone have been shown to be active and tolerable.

In this study patients with relapsed/progressive or refractory multiple myeloma will start treatment with bortezomiib and Dexamethasone. Response will be evaluated after four cycles. Patients with complete, very good partial response or partial response will continue treatment as initiated. Patients with stable disease will either continue treatment with the bortezomib/Dexamethasone combination for another four cycles or will receive Cyclophosphamide or Lenalidomide as an additional third agent for another four cycles.

Patients with multiple myeloma that are refractory to or have relapsed/progressed after primary treatment for multiple myeloma will be enrolled in the study. All patients will receive a combination of bortezomib plus dexamethasone for a total of four cycles. Based on the response to this treatment, further study treatment is customized. Patients with a complete, a very good partial or a partial response will continue to receive bortezomib and Dexamethasone for a maximum additional four cycles, to an overall maximum of eight cycles. Patients achieving stable disease, as defined by International Myeloma Working Group 2006 (IMWG 2006) response criteria, will undergo a central randomisation to continue treatment with VD or VD plus cyclophosphamide or VD plus lenalidomide. Patients with progressive disease will go off study treatment. After randomisation, patients will receive therapy for up to four additional treatment cycles, to an overall maximum of eight cycles. Each cycle will consist of three weeks treatment. There will be a long-term follow-up period with monthly visits until relapse or progressive disease. Thereafter follow-up for survival will be continued by at least a phone call every other month. This will be performed for all patients until the last patient was treated and followed up for 1 year.

Safety will be assessed by the monitoring of adverse events, physical examination (including neurological/peripheral neurological examinations), pulmonary examinations, vital signs measurements, and clinical laboratory tests.

Patients will be treated in a 3-week cycle, up to a maximum of 8 cycles bortezomib 1.3 mg/m2 will be administered on day 1, 4, 8 and 11 as i.v. bolus infusion.

Dexamethasone 20 mg po will be administered on days 1, 2, 4, 5, 8, 9, 11, 12. Dexamethasone will be administered as 2 tables of 8 mg plus 1 tablet of 4 mg Cyclophosphamide 500 mg po will be administered as 10 tablets of 50 mg on day 1, 8, 15 Lenalidomide will be administered as once daily 10 mg tablet from day 1 to 14

Treatment With Velcade (Bortezomib) Plus Dexamethasone (VD) or VD Plus Cyclophosphamide or VD Plus Lenalidomide in Patients With Multiple Myeloma Stabilized After 4 Cycles of VD

Efficacy and Safety of Velcade Plus Dexamethasone (VD), VD+Cyclophosphamide or VD Plus Lenalidomide in MMY Patients Who Are Refractory or Have Relapsed After Their Primary Therapy for MMY and Have Achieved Stable Disease After 4 Cycles of VD

Overall Best Confirmed Response is the best Overall Response Rate with borezomib-dexamathasone (+/-cyclophosphamide or lenalidomide) recorded between baseline and end of treatment. Response was assessed using the International Myeloma working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.

Time from start of treatment to the date of the first documentation of a confirmed response. Estimated using the Kaplan-Meier method. Response was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.

Time from start of treatment to date of disease progression, relapse from CR or death. Estimated using the kaplan-meier method. 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", or similar definition as accurate and appropriate.

Is calculated as the time from start of treatment to the date of the first observation of disease progression or relapse from CR. Deaths owing to causes other than progression not counted, but censored. Subjects who withdraw from the study or die will be censored at the time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).

Percent Probability of Survival at 1 year from the start of treatment, estimated using Kaplan-Meier analysis.

Is defined as the time interval from start of treatment to the date of death due to any cause. In the absence of confirmation of death (including subjects lost to follow-up), survival time will be censored at the last date the subject is known to be alive

Janssen-Cilag International NV

Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.

Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8

Complete to Partial Response: Bortezomib + Dexamethasone

Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8

Stable Disease After 4 Cycles: VD, VDC, VDL

bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles

France

Germany

Greece

Hungary

Lithuania

Poland

Serbia

Spain

Turkey

United Kingdom

modified Intent to Treat Population consisting of all 163 participants with at least 1 dose and 1 post baseline efficacy assessment.: Complete and Partial Responders (non-randomized), n=144. Stable Disease (randomized to VD, VDC, and VDL), n=19.

The response rate of bortezomib in combination with dexamethasone after 4 cycles was much higher than originally assumed. Therefore the sample size of the randomized groups is too small for further statistical analysis.

EMEA Medical Affairs Director Oncology

mITT: All patients with at least 1 dose and 1 post baseline assessment. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19). Data are missing for 21 patients in the non-randomized CR/PR group, n=123.

Overall Best Confirmed Response

mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).

Median Time to First Confirmed Response

mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).

Progression Free Survival

mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).

Time to Progression

One Year Survival

Overall Survival

Cycle 1 to 4: Bortezomib + Dexamethasone (VD)

Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8

Stable Disease: Bortezomib + Dexamethasone (VD)

Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and cyclophosphamide 500 mg, orally daily, days 1, 8 and 15 for cycle 5 to 8

SD: Bortezomib+Dexamethasone+Cyclophosphamide (VDC)

Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotherapy and Paraneoplastic Neurological Syndromes	NCT02343211	Paraneoplastic ...	Immunoglobulin	18 Years -	Assistance Publique - Hôpitaux de Paris
Tolerance and Patients' Satisfaction With IGHy	NCT03668288	Secondary or Pr...	Data record and...	18 Years -	CHU de Reims
Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder	NCT03250845	Hematologic Dis... Secondary Immun...		18 Years -	Universitaire Ziekenhuizen KU Leuven
Immunotherapy and Paraneoplastic Neurological Syndromes	NCT02343211	Paraneoplastic ...	Immunoglobulin	18 Years -	Assistance Publique - Hôpitaux de Paris
Treatment With Velcade (Bortezomib) Plus Dexamethasone (VD) or VD Plus Cyclophosphamide or VD Plus Lenalidomide in Patients With Multiple Myeloma Stabilized After 4 Cycles of VD	NCT00908232	Multiple Myelom...	Cyclophosphamid... Bortezomib Dexamethasone Lenalidomide	18 Years -	Janssen-Cilag International NV

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