A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma

• Sponsor: Sherif S. Farag (Other)
• Overall Status: Completed
• CT.gov ID: NCT02078102
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 38
• Location: 1
• Arm: 1
• Actual Duration (Months): 59.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The trial is an open label Simon optimal two-stage Phase II trial of fixed doses of oral meloxicam and subcutaneous filgrastim to assess the safety and efficacy in mobilizing autologous peripheral blood stem cells (PBSC) from multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) patients planning to undergo high-dose chemotherapy with stem cell support. Clinical data regarding the cellular composition and function of the graft mobilized by this combination will be obtained.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma; Non-Hodgkin's Lymphoma	Drug: Meloxicam; Drug: Filgrastim	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Prostaglandin E2 Inhibition, Using Meloxicam, Plus Filgrastim for Mobilization of Autologous Peripheral Blood Stem Cells in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma
• Actual Study Start Date: Mar 11, 2014
• Actual Primary Completion Date: Nov 6, 2018
• Actual Study Completion Date: Feb 21, 2019

Arms and Interventions

Arm

Intervention/Treatment

Other: Treatment Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.

Drug: Meloxicam; 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.; Other Names: Mobic ; Drug: Filgrastim; Filgrastim will be subcutaneously injected in one or two sites at home.; Other Names: Neupogen

Outcome Measures

Primary Outcome Measures

1. Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis [within 100 days of transplant]

   Percent of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis with binomial exact confidence intervals according to disease: Multiple myeloma patients: percent of patients with >= 5x106 CD34 cells/kg in the first day's apheresis. Non-Hodgkin's lymphoma patients: percent of patients with >= 2.5x106 CD34 cells/kg in the first day's apheresis.

Secondary Outcome Measures

1. Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity [within 100 days of transplant]

   Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

2. Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point [Cycle 2, Days 1-4, within 100 days of transplant]

   Mean and Standard Deviation of the Graft Composition of Peripheral Blood Stem Cell Collection (CD34 (x10^6cells/kg)) at each time point collected during Cycle 2.

3. Time to Neutrophil Engraftment [within 100 days of transplant]

   Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. The median and 95% confidence intervals will be provided. Only patients with neutrophil engraftment will be included.

4. Time to Platelet Engraftment [within 100 days of transplant]

   Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. The median and 95% confidence intervals will be provided. Only patients achieving platelet engraftment will be included.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:

1. Has provided written informed consent prior to completing any study procedures.

2. Patients must have a previously documented histologic diagnosis of multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), and be eligible to undergo autologous PBSC transplantation on institutional protocols.

3. Multiple myeloma should be in first or second partial response or better, as defined by International Myeloma Working Group criteria.50

4. Non-Hodgkin's lymphoma must be in either first or second partial response or better and have any one of the following histologies:

• Diffuse large B cell lymphoma

• Transformed lymphoma

• Mantle cell lymphoma

• Follicular lymphoma (any grade)

• Peripheral T cell lymphoma

1. Age ≥18 to ≤75 years at time of consent.

2. Karnofsky performance status of at least 70%.

3. Adequate organ function defined as:

4. Left ventricular ejection fraction ≥45%

5. Corrected DLCO ≥50%

6. Serum bilirubin, AST (aspartate aminotransferase) and ALT(alanine aminotransferase) ≤ twice the upper limit of normal

7. Serum creatinine ≤ 2.0 mg/dl

8. Urine M-protein ≤1 g/24 hours (MM patients only)

9. No prior attempt at mobilizing PBSC.

10. Patients must be at least 4 weeks from last cytotoxic chemotherapy (including alkylating, anthracyclines, epipodophylatoxins, and platinum drugs), or immunomodulatory drugs (including lenalidomide or pomalidomide, or related derivatives) at time of treatment on this protocol.

11. Patients must be at least 2 weeks from last treatment with a proteasome inhibitor (e.g., bortezomib, carfilzomib) at time of treatment on this protocol.

12. Patients must be negative for HIV.

13. Women of childbearing potential must have a negative pregnancy test (urine or serum) and must not be lactating at the time of informed consent.

14. Women and men must use adequate birth control while taking part in this study (such as a condom or diaphragm with contraceptive cream/jelly, birth control pills, Norplant, abstinence (no sexual intercourse) or surgical sterilization.

Exclusion Criteria:

Exclude a patient if any of the following conditions are observed:

1. Patients must not have received radiation therapy within the past 4 weeks, and not to more than 20% of hematopoiesis forming bones (spine, pelvis and proximal long bones).

2. Patients must not have active central nervous system involvement.

3. Patients must not have a prior autologous, syngeneic or allogeneic hematopoietic stem cell transplant.

4. Patients must not have received prior bone seeking radionuclides.

5. Patients must not have received myeloid growth factors within 2 weeks before mobilization attempt on this study.

6. Patients must not have taken nonsteroidal antiinflammatory drugs (NSAID) in the past 14 days before treatment on this protocol.

7. Patients must not have nor had active or recent peptic ulcer disease within the past 6 months.

1. Patients with active significant symptoms of dyspepsia will be excluded.

1. Patients with a history of asthma will be excluded because of the potential for NSAID to precipitate asthma in these patients.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Sherif S. Farag
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Sherif Farag, M.D., Ph.D., Indiana University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 21, 2016

More Information

Publications

None provided.

• Responsible Party: Sherif S. Farag, Principal Investigator, Indiana University School of Medicine
• ClinicalTrials.gov Identifier: NCT02078102
• Other Study ID Numbers: IUCRO-0419; CA182947; 1312925163
• First Posted: Mar 5, 2014
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin; Meloxicam

Study Results

Participant Flow

Arm/Group Title	Multiple Myeloma	Non Hodgkins Lymphoma
Arm/Group Description	This is for the patients with Multiple Myeloma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.	This is for the patients with Non Hodgkins Lymphoma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
Period Title: Overall Study
STARTED	25	13
COMPLETED	23	12
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Multiple Myeloma	Non Hodgkins Lymphoma	Total
Arm/Group Description	This is for the patients with Multiple Myeloma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.	This is for the patients with Non Hodgkins Lymphoma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.	Total of all reporting groups
Overall Participants	25	13	38
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 64%	11 84.6%	27 71.1%
>=65 years	9 36%	2 15.4%	11 28.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.1 (8.6)	51.2 (16.1)	57.8 (12.5)
Sex: Female, Male (Count of Participants)
Female	12 48%	5 38.5%	17 44.7%
Male	13 52%	8 61.5%	21 55.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	22 88%	11 84.6%	33 86.8%
Unknown or Not Reported	3 12%	2 15.4%	5 13.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 8%	1 7.7%	3 7.9%
White	21 84%	10 76.9%	31 81.6%
More than one race	1 4%	0 0%	1 2.6%
Unknown or Not Reported	1 4%	2 15.4%	3 7.9%
Disease Status at Registration (Count of Participants)
Partial Response	19 76%	0 0%	19 50%
Partial Response without prior Complete Response	0 0%	1 7.7%	1 2.6%
Very Good Partial Response	5 20%	1 7.7%	6 15.8%
Complete Remission	1 4%	9 69.2%	10 26.3%
Complete Remission Confirmed	0 0%	1 7.7%	1 2.6%
Unknown	0 0%	1 7.7%	1 2.6%

Outcome Measures

1. Primary Outcome

Title	Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
Description	Percent of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis with binomial exact confidence intervals according to disease: Multiple myeloma patients: percent of patients with >= 5x106 CD34 cells/kg in the first day's apheresis. Non-Hodgkin's lymphoma patients: percent of patients with >= 2.5x106 CD34 cells/kg in the first day's apheresis.
Time Frame	within 100 days of transplant

Outcome Measure Data

Analysis Population Description

Patients with available post-transplant CD34+ results.

Arm/Group Title	Multiple Myeloma	Non Hodgkins Lymphoma
Arm/Group Description	This is for the patients with Multiple Myeloma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.	This is for the patients with Non Hodgkins Lymphoma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
Measure Participants	25	12
Number (95% Confidence Interval) [percentage of participants]	32.0 128%	58.3 448.5%

2. Secondary Outcome

Title	Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity
Description	Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame	within 100 days of transplant

Outcome Measure Data

Analysis Population Description

All patients who received a transplant.

Arm/Group Title	Multiple Myeloma	Non Hodgkins Lymphoma
Arm/Group Description	This is for the patients with Multiple Myeloma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.	This is for the patients with Non Hodgkins Lymphoma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
Measure Participants	25	13
Count of Participants [Participants]	0 0%	0 0%

3. Secondary Outcome

Title	Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
Description	Mean and Standard Deviation of the Graft Composition of Peripheral Blood Stem Cell Collection (CD34 (x10^6cells/kg)) at each time point collected during Cycle 2.
Time Frame	Cycle 2, Days 1-4, within 100 days of transplant

Outcome Measure Data

Analysis Population Description

Patients with available post-transplant CD34 (x10^6/kg) data.

Arm/Group Title	Multiple Myeloma	Non Hodgkins Lymphoma
Arm/Group Description	This is for the patients with Multiple Myeloma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.	This is for the patients with Non Hodgkins Lymphoma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
Measure Participants	25	12
Cycle 2 Day 1	3.42 (2.72)	3.22 (2.20)
Cycle 2 Day 2	4.92 (2.86)	3.51 (2.67)
Cycle 2 Day 3	2.63 (1.70)	0.89 (0.45)
Cycle 2 Day 4	1.55 (0.35)	0.90 (NA)

4. Secondary Outcome

Title	Time to Neutrophil Engraftment
Description	Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. The median and 95% confidence intervals will be provided. Only patients with neutrophil engraftment will be included.
Time Frame	within 100 days of transplant

Outcome Measure Data

Analysis Population Description

All patients who had a transplant and engrafted. All patients were analyzed together since the definition for neutrophil engraftment is the same regardless of disease and only the time until overall neutrophil engraftment was the outcome of interest.

Arm/Group Title	Treatment Group
Arm/Group Description	Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
Measure Participants	34
Median (95% Confidence Interval) [days]	13.0

5. Secondary Outcome

Title	Time to Platelet Engraftment
Description	Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. The median and 95% confidence intervals will be provided. Only patients achieving platelet engraftment will be included.
Time Frame	within 100 days of transplant

Outcome Measure Data

Analysis Population Description

All patients who received a transplant and engrafted. All patients were analyzed together since the definition for platelet engraftment is the same regardless of disease and only the time until overall platelet engraftment was the outcome of interest.

Arm/Group Title	Treatment Group
Arm/Group Description	Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
Measure Participants	34
Median (95% Confidence Interval) [days]	16.5

Adverse Events

Time Frame	up to 100 days post-transplant
Arm/Group Title	Multiple Myeloma		Non Hodgkins Lymphoma
Arm/Group Description	This is for the patients with Multiple Myeloma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.		This is for the patients with Non Hodgkins Lymphoma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
All Cause Mortality
	Multiple Myeloma		Non Hodgkins Lymphoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/25 (16%)		1/13 (7.7%)
Serious Adverse Events
	Multiple Myeloma		Non Hodgkins Lymphoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/25 (4%)		1/13 (7.7%)
Gastrointestinal disorders
Diarrhea	1/25 (4%)		0/13 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	0/25 (0%)		1/13 (7.7%)
Other (Not Including Serious) Adverse Events
	Multiple Myeloma		Non Hodgkins Lymphoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/25 (40%)		10/13 (76.9%)
Blood and lymphatic system disorders
Anemia	0/25 (0%)		2/13 (15.4%)
Cardiac disorders
Chest pain - cardiac	1/25 (4%)		1/13 (7.7%)
Gastrointestinal disorders
Abdominal pain	0/25 (0%)		2/13 (15.4%)
Nausea	4/25 (16%)		6/13 (46.2%)
Oral dysesthesia	0/25 (0%)		1/13 (7.7%)
General disorders
Fatigue	1/25 (4%)		1/13 (7.7%)
Pain	1/25 (4%)		2/13 (15.4%)
Infections and infestations
Skin infection	0/25 (0%)		1/13 (7.7%)
Upper respiratory infection	2/25 (8%)		0/13 (0%)
Investigations
Platelet count decreased	1/25 (4%)		2/13 (15.4%)
Metabolism and nutrition disorders
Hypocalcemia	1/25 (4%)		3/13 (23.1%)
Hypokalemia	0/25 (0%)		1/13 (7.7%)
Musculoskeletal and connective tissue disorders
Back pain	0/25 (0%)		1/13 (7.7%)
Bone pain	0/25 (0%)		2/13 (15.4%)
Myalgia	1/25 (4%)		1/13 (7.7%)
Nervous system disorders
Headache	0/25 (0%)		1/13 (7.7%)
Paresthesia	1/25 (4%)		1/13 (7.7%)
Skin and subcutaneous tissue disorders
Rash maculo-papular	0/25 (0%)		1/13 (7.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.