Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00478218
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 53
• Locations: 2
• Arm: 1
• Duration (Months): 57
• Patients Per Site: 26.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with newly diagnosed multiple myeloma.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: cyclophosphamide; Drug: dexamethasone; Drug: lenalidomide	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Assess the response rate in patients with newly diagnosed active multiple myeloma treated with lenalidomide, cyclophosphamide, and dexamethasone.

Secondary

• Assess the toxicity of this regimen in these patients.

• Determine the time to progression in patients treated with this regimen. OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide on days 1, 8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Lenalidomide/Cyclophosphamide/Dexamethasone

Drug: cyclophosphamide; 300 mg/m2 administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) OR 300 mg administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles); Other Names: Cytoxan, CTX, Neosar® ; Drug: dexamethasone; 40 mg administrated by PO (with food)on Days 1, 8, 15 & 22; Other Names: Decadron ; Drug: lenalidomide; 25 mg administrated by PO (with food)on Days 1-21; Other Names: Revlimid®

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment [Duration of Treatment (up to 5 years)]

   Response that was confirmed on 2 consecutive evaluations during treatment Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM) Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels

Secondary Outcome Measures

1. Overall Survival (OS) [up to 5 years]

   OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.

2. Progression-free Survival (PFS) [up to 5 years]

   PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.> Progression was defined as any one or more of the following:> An increase of 25% from lowest confirmed response in:> Serum M-component (absolute increase >= 0.5g/dl)> Urine M-component (absolute increase >= 200mg/24hour> Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl> Bone marrow plasma cell percentage (absolute increase of >=10%)

3. Duration of Response (DOR) [up to 5 years]

   Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method.

Eligibility Criteria

Criteria

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

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma

• Newly diagnosed disease

• Symptomatic disease

• Measurable or evaluable disease, defined by ≥ 1 of the following criteria:

• Serum monoclonal protein ≥ 1.0 g by protein electrophoresis

• Monoclonal protein > 200 mg by 24-hour urine electrophoresis

• Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio

• Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)

• Measurable soft tissue plasmacytoma not previously irradiated

• No monoclonal gammopathy of undetermined significance or smoldering myeloma

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if secondary to pain)

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 75,000/mm^3

• Hemoglobin ≥ 8.0 g/dL

• Creatinine ≤ 2.5 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for 1 month before, during, and for 4 weeks after completion of study therapy

• No uncontrolled infection

• No other active malignancy

• No other malignancies within the past 5 years except for currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast

• No NYHA class III-IV congestive heart failure

• No untreated active deep vein thrombosis

PRIOR CONCURRENT THERAPY:

• At least 3 weeks since prior radiotherapy for solitary plasmacytoma

• Prior clarithromycin, therapeutic dehydroepiandrosterone (DHEA), anakinra, pamidronate disodium, or zoledronic acid allowed

• No prior cytotoxic chemotherapy

• No prior corticosteroids (except for treatment of a nonmalignant disorder)

• Concurrent corticosteroids (prednisone ≤ 20 mg/per day) allowed

• No concurrent radiotherapy except palliative radiotherapy for a single painful bone lesion or fracture

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259-5499
2	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• National Cancer Institute (NCI)

Investigators

• Study Chair: Shaji K. Kumar, MD, Mayo Clinic
• Principal Investigator: Craig B. Reeder, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00478218
• Other Study ID Numbers: CDR0000546657; P30CA015083; MC058E; 06-002786; RV-MM-PI-0116
• First Posted: May 24, 2007
• Last Update Posted: Aug 31, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by Mayo Clinic: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Dexamethasone; Cyclophosphamide; Lenalidomide

Study Results

Participant Flow

Recruitment Details	Fifty-three (53) participants were recruited between July 2006 and August 2008 at Mayo Clinic.

Arm/Group Title	LCD (Cyclophosphamide 300 mg/m^2)	LCD (Cyclophosphamide 300 mg)
Arm/Group Description	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
Period Title: Overall Study
STARTED	34	19
COMPLETED	34	19
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	LCD (Cyclophosphamide 300 mg/m^2)	LCD (Cyclophosphamide 300 mg)	Total
Arm/Group Description	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22	Total of all reporting groups
Overall Participants	34	19	53
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	63.5	65	64
Sex: Female, Male (Count of Participants)
Female	17 50%	9 47.4%	26 49.1%
Male	17 50%	10 52.6%	27 50.9%
Region of Enrollment (participants) [Number]
United States	34 100%	19 100%	53 100%
Durie Salmon Stage (paricipants) [Number]
Stage IA - Low Cell Mass	3	1	4
Stage IIA - Intermediate Cell Mass	7	11	18
Stage IIIA/B - High Cell Mass	24	7	31
Parameter of Hematologic Response - Serum M-spike >= 1 g/dL (participants) [Number]
Yes	25 73.5%	14 73.7%	39 73.6%
No	9 26.5%	5 26.3%	14 26.4%
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >= 10 mg/dL (participants) [Number]
Yes	21 61.8%	14 73.7%	35 66%
No	13 38.2%	5 26.3%	18 34%
Parameter of Hematologic Response - Urine M-Spike >= 200 mg/24 hours (participants) [Number]
Yes	11 32.4%	5 26.3%	16 30.2%
No	23 67.6%	14 73.7%	37 69.8%
Parameter of Hematologic Response - Bone Marrow Plasma Cells > 30% (participants) [Number]
Yes	17 50%	14 73.7%	31 58.5%
No	17 50%	5 26.3%	22 41.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment
Description	Response that was confirmed on 2 consecutive evaluations during treatment Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM) Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels
Time Frame	Duration of Treatment (up to 5 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LCD (Cyclophosphamide 300 mg/m^2)	LCD (Cyclophosphamide 300 mg)
Arm/Group Description	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
Measure Participants	34	19
Number [participants]	28 82.4%	16 84.2%

2. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LCD (Cyclophosphamide 300 mg/m^2)	LCD (Cyclophosphamide 300 mg)
Arm/Group Description	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
Measure Participants	34	19
Median (95% Confidence Interval) [months]	NA	NA

3. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.> Progression was defined as any one or more of the following:> An increase of 25% from lowest confirmed response in:> Serum M-component (absolute increase >= 0.5g/dl)> Urine M-component (absolute increase >= 200mg/24hour> Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl> Bone marrow plasma cell percentage (absolute increase of >=10%)
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LCD (Cyclophosphamide 300 mg/m^2)	LCD (Cyclophosphamide 300 mg)
Arm/Group Description	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
Measure Participants	34	19
Median (95% Confidence Interval) [months]	27	NA

4. Secondary Outcome

Title	Duration of Response (DOR)
Description	Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method.
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

Participants who achieved a partial response(PR) or better were evaluable for this analysis.

Arm/Group Title	LCD (Cyclophosphamide 300 mg/m^2)	LCD (Cyclophosphamide 300 mg)
Arm/Group Description	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
Measure Participants	26	16
Median (95% Confidence Interval) [months]	26.1	NA

Adverse Events

Arm/Group Title	LCD (Cyclophosphamide 300 mg/m^2)		LCD (Cyclophosphamide 300 mg)
Arm/Group Description	Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22		Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
All Cause Mortality
	LCD (Cyclophosphamide 300 mg/m^2)		LCD (Cyclophosphamide 300 mg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LCD (Cyclophosphamide 300 mg/m^2)		LCD (Cyclophosphamide 300 mg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/34 (38.2%)		2/19 (10.5%)
Blood and lymphatic system disorders
Febrile neutropenia	1/34 (2.9%)	1	1/19 (5.3%)	1
Cardiac disorders
Atrial fibrillation	1/34 (2.9%)	1	0/19 (0%)	0
Gastrointestinal disorders
Lower gastrointestinal hemorrhage	1/34 (2.9%)	1	0/19 (0%)	0
Nausea	1/34 (2.9%)	1	0/19 (0%)	0
General disorders
Death NOS	0/34 (0%)	0	1/19 (5.3%)	1
Infections and infestations
Lung (pneumonia) infection	0/34 (0%)	0	1/19 (5.3%)	1
Pneumonia	1/34 (2.9%)	1	0/19 (0%)	0
Sepsis	1/34 (2.9%)	1	0/19 (0%)	0
Skin (cellulites) infection	1/34 (2.9%)	1	0/19 (0%)	0
Investigations
Creatinine	1/34 (2.9%)	1	0/19 (0%)	0
Leukopenia	2/34 (5.9%)	2	0/19 (0%)	0
Neutropenia	5/34 (14.7%)	5	0/19 (0%)	0
Platelet count decreased	1/34 (2.9%)	2	0/19 (0%)	0
Metabolism and nutrition disorders
Hypocalcemia	1/34 (2.9%)	1	0/19 (0%)	0
Hypokalemia	1/34 (2.9%)	1	0/19 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	2/34 (5.9%)	2	1/19 (5.3%)	1
Pain in extremity	1/34 (2.9%)	1	0/19 (0%)	0
Nervous system disorders
Ischemia-Cerebral	1/34 (2.9%)	1	0/19 (0%)	0
Psychiatric disorders
Confusion	1/34 (2.9%)	1	0/19 (0%)	0
Depression	1/34 (2.9%)	1	0/19 (0%)	0
Renal and urinary disorders
Renal Failure	1/34 (2.9%)	1	0/19 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea	0/34 (0%)	0	1/19 (5.3%)	1
Vascular disorders
Hypotension	1/34 (2.9%)	1	0/19 (0%)	0
Thrombosis	3/34 (8.8%)	3	1/19 (5.3%)	1
Other (Not Including Serious) Adverse Events
	LCD (Cyclophosphamide 300 mg/m^2)		LCD (Cyclophosphamide 300 mg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/34 (100%)		19/19 (100%)
Blood and lymphatic system disorders
Anemia	14/34 (41.2%)	50	10/19 (52.6%)	37
Cardiac disorders
Atrial fibrillation	1/34 (2.9%)	1	0/19 (0%)	0
Cardiovascular	1/34 (2.9%)	1	0/19 (0%)	0
Sinus bradycardia	1/34 (2.9%)	1	1/19 (5.3%)	1
Endocrine disorders
Hypothyroidism	2/34 (5.9%)	3	1/19 (5.3%)	1
Eye disorders
Cataract	1/34 (2.9%)	1	0/19 (0%)	0
Gastrointestinal disorders
Constipation	2/34 (5.9%)	2	2/19 (10.5%)	3
Diarrhea-No Colostom	7/34 (20.6%)	17	3/19 (15.8%)	6
Dyspepsia	1/34 (2.9%)	1	1/19 (5.3%)	1
Nausea	3/34 (8.8%)	5	0/19 (0%)	0
Oral cavity Mucositis/stomatitis (functional/symptomatic)	0/34 (0%)	0	1/19 (5.3%)	1
Pain-Abdominal	2/34 (5.9%)	2	0/19 (0%)	0
Vomiting	3/34 (8.8%)	3	0/19 (0%)	0
General disorders
Edema: Limb	3/34 (8.8%)	5	1/19 (5.3%)	1
Fatigue	31/34 (91.2%)	239	18/19 (94.7%)	174
Fever-No ANC	0/34 (0%)	0	2/19 (10.5%)	2
Infections and infestations
Pneumonia	1/34 (2.9%)	1	0/19 (0%)	0
Respiratory tract infection	1/34 (2.9%)	1	1/19 (5.3%)	1
Skin (cellulites) infection	1/34 (2.9%)	1	0/19 (0%)	0
Investigations
Creatinine	1/34 (2.9%)	1	0/19 (0%)	0
Leukopenia	21/34 (61.8%)	96	14/19 (73.7%)	67
Lymphopenia	2/34 (5.9%)	24	4/19 (21.1%)	24
Neutropenia	31/34 (91.2%)	288	16/19 (84.2%)	163
Platelet count decreased	19/34 (55.9%)	70	12/19 (63.2%)	86
Metabolism and nutrition disorders
Anorexia	1/34 (2.9%)	1	0/19 (0%)	0
Dehydration	1/34 (2.9%)	1	0/19 (0%)	0
Hyperglycemia	0/34 (0%)	0	5/19 (26.3%)	13
Hyperkalemia	1/34 (2.9%)	1	0/19 (0%)	0
Hypocalcemia	0/34 (0%)	0	1/19 (5.3%)	1
Hypoglycemia	1/34 (2.9%)	1	0/19 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	1/34 (2.9%)	1	2/19 (10.5%)	2
Back pain	3/34 (8.8%)	8	1/19 (5.3%)	2
Bone pain	3/34 (8.8%)	7	0/19 (0%)	0
Extremity-lower weakness	1/34 (2.9%)	1	3/19 (15.8%)	5
Extremity-upper weakness	1/34 (2.9%)	1	1/19 (5.3%)	1
Muscle Weakness	4/34 (11.8%)	4	3/19 (15.8%)	4
Musculoskeletal	1/34 (2.9%)	1	0/19 (0%)	0
Myalgia	2/34 (5.9%)	2	1/19 (5.3%)	4
Neck pain	1/34 (2.9%)	2	0/19 (0%)	0
Pain in extremity	2/34 (5.9%)	3	3/19 (15.8%)	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy	1/34 (2.9%)	1	0/19 (0%)	0
Nervous system disorders
Peripheral motor neuropathy	0/34 (0%)	0	1/19 (5.3%)	1
Peripheral sensory neuropathy	17/34 (50%)	61	14/19 (73.7%)	108
Syncope	0/34 (0%)	0	1/19 (5.3%)	1
Syncope Vasovagal	0/34 (0%)	0	1/19 (5.3%)	1
Tremor	1/34 (2.9%)	1	2/19 (10.5%)	3
Psychiatric disorders
Agitation	4/34 (11.8%)	8	0/19 (0%)	0
Anxiety	5/34 (14.7%)	8	1/19 (5.3%)	1
Confusion	2/34 (5.9%)	3	0/19 (0%)	0
Depression	4/34 (11.8%)	5	2/19 (10.5%)	2
Euphoria	1/34 (2.9%)	1	0/19 (0%)	0
Insomnia	3/34 (8.8%)	12	4/19 (21.1%)	6
Renal and urinary disorders
Cystitis	6/34 (17.6%)	8	2/19 (10.5%)	2
Renal Failure	1/34 (2.9%)	1	0/19 (0%)	0
Reproductive system and breast disorders
Impotence	1/34 (2.9%)	1	0/19 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	1/34 (2.9%)	1	0/19 (0%)	0
Dyspnea	2/34 (5.9%)	2	0/19 (0%)	0
Skin and subcutaneous tissue disorders
Petechiae	0/34 (0%)	0	1/19 (5.3%)	1
Rash/Desquamation	3/34 (8.8%)	5	4/19 (21.1%)	8
Skin Irritation	0/34 (0%)	0	1/19 (5.3%)	2
Vascular disorders
Phlebitis	1/34 (2.9%)	1	0/19 (0%)	0
Thrombosis	4/34 (11.8%)	5	1/19 (5.3%)	1

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.